Reported trial results for Psoriasis
Every Psoriasis trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
246 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
-
NCT06095102 · results posted 25 June 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT06095102) enrolled 311 people with plaque psoriasis — 103 received a placebo (an inactive treatment) and 208 received a pill called JNJ-77242113 at a dose of 200 mg. By the end of the study, 93 people in the placebo group and 200 in the JNJ-77242113 group had completed the trial. The trial was measuring how participants' psoriasis responded after 16 weeks, using several scoring systems where doctors rated the severity of skin plaques, scalp involvement, genital skin involvement, and hand and foot involvement. The reported data shows the following figures at the 16-week mark. For the main (primary) outcome — the proportion of participants whose overall skin score reached "clear" or "minimal" and improved by at least two grades — 5.8% of the placebo group and 56.7% of the JNJ-77242113 group met this measure. For the secondary outcomes: regarding scalp psoriasis (among those with moderate-to-severe scalp disease at the start), 10.6% in the placebo group and 65.9% in the JNJ-77242113 group reached a "clear" or "minimal" scalp score, while 5.9% versus 57.5% achieved at least a 90% improvement on a separate scalp scoring tool. For genital psoriasis (again, among those with moderate-to-severe disease at baseline), 21.4% in the placebo group and 76.5% in the JNJ-77242113 group reached a "clear" or "minimal" score. For hand and foot psoriasis, those figures were 26.1% and 41.7% respectively. Finally, the proportion whose overall skin score reached fully "clear" (the highest possible improvement) was 1.0% in the placebo group and 25.5% in the JNJ-77242113 group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT06220604 · results posted 25 June 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 731 adults with plaque psoriasis across three groups: 82 people received a placebo (dummy treatment) for the first 16 weeks before switching to the study drug JNJ-77242113 (200 mg); 322 people received JNJ-77242113 (200 mg) from the start; and 327 people received a comparator drug called deucravacitinib (6 mg). The trial was primarily measuring how many participants' skin cleared or nearly cleared by week 16, using two standard psoriasis scoring tools — one rated by a doctor's overall assessment of the skin (IGA), and one that scores redness, thickness, and scaling across the whole body (PASI). The reported data shows the following results at week 16, comparing the placebo group to the JNJ-77242113 group. On the doctor's skin assessment (IGA), 70.9% of participants taking JNJ-77242113 reached a score of "clear" or "almost clear," compared with 8.6% in the placebo group. For the body-wide skin score (PASI), 57.5% of the JNJ-77242113 group showed at least a 90% reduction from their starting score, compared with 1.2% in the placebo group. Among the secondary measures also reported: 36.9% of the JNJ-77242113 group had a completely clear skin score (IGA of 0) versus 1.2% on placebo; 77.8% of the JNJ-77242113 group showed at least a 75% improvement on the body score by week 16 (versus 9.9% on placebo); 31.9% showed a full 100% clearance on the body score (versus 1.2% on placebo); and at the earlier week 8 check-in, 25.3% of the JNJ-77242113 group had already reached 90% improvement on the body score, compared with 0% on placebo. Results for the deucravacitinib group were not included in the outcome measure data as reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT06143878 · results posted 25 June 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 774 adults with plaque psoriasis across three groups: 156 people received a placebo (inactive treatment) for the first 16 weeks before switching to the study drug JNJ-77242113 200 mg; 311 people received JNJ-77242113 200 mg from the start; and 307 people received an already-approved medicine called deucravacitinib 6 mg. The trial was primarily measuring how many participants showed a meaningful improvement in their skin at 16 weeks, using two standard psoriasis scoring tools — one rated by a doctor (the IGA scale) and one that measures how much of the body is affected and how severe the patches are (the PASI scale). It is worth noting that the reported outcome data only compared the placebo group and the JNJ-77242113 group; figures for the deucravacitinib group were not included in the submitted results data. The reported data shows that, at 16 weeks, 68.5% of participants who received JNJ-77242113 from the start reached a doctor-assessed skin score of "clear" or "almost clear" (IGA 0 or 1), compared with 10.9% in the placebo group. On the PASI scale, 55.0% of the JNJ-77242113 group achieved at least a 90% reduction in their psoriasis score from where they started, versus 3.8% in the placebo group. For complete clearance of the skin score (PASI 100), the reported figures were 31.2% for JNJ-77242113 and 1.3% for placebo. Earlier in the trial, at week 4, the reported data shows 12.2% of the JNJ-77242113 group had reached a 75% improvement in their PASI score, rising to 74.3% by week 16, compared with 2.6% and 11.5% respectively for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT05272150 · results posted 24 June 2026
According to the results reported on ClinicalTrials.gov, this trial looked at guselkumab (a 100 mg injection) compared to a placebo (an inactive treatment) in people with psoriasis. The trial was split into two groups: Cohort A focused on general plaque psoriasis across the body, and Cohort B focused on scalp psoriasis. In total, 211 people started the trial — 103 in Cohort A and 108 in Cohort B. Some participants who started on placebo later switched to guselkumab during the study. The main things being measured at the 16-week mark were how many participants had their skin condition rated as "cleared" or nearly cleared by a doctor, and how much improvement was seen in standardised skin-scoring systems. The reported data shows the following figures at Week 16. In Cohort A (body plaque psoriasis), 74% of participants receiving guselkumab had their skin rated as "cleared" or "minimal" by the doctor's assessment, compared with 0% in the placebo group. Using a separate body-wide scoring system (PASI), 57.1% of the guselkumab group showed at least 90% improvement from their starting score, versus 3.8% in the placebo group. For complete clearance on that same scoring system, 29.9% of the guselkumab group met that threshold, compared with 0% in the placebo group. In Cohort B (scalp psoriasis), 68.4% of people on guselkumab had their scalp rated as "no disease" or "very mild" by the doctor, versus 11.5% on placebo. Using the scalp-specific scoring system, 65.8% of the guselkumab group showed at least 90% improvement from their starting score, compared with 3.8% in the placebo group. It is worth noting that the placebo group participants eventually crossed over to receive guselkumab, so their placebo-period results reflect only that earlier phase of the study. The reported data describes what was measured at a specific point in time within the trial's design, and these figures relate to the participants in this particular study only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01872546 · results posted 24 June 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 18 adults who received a medication called adalimumab. All 18 participants completed the study — none dropped out. The trial was looking at two things after 4 weeks of treatment: changes in a skin disease severity score called the PASI (Psoriasis Area and Severity Index, a standard way of measuring how much of the body is affected by psoriasis and how severe it looks), and changes in a quality-of-life score called the DLQI (Dermatology Life Quality Index, a questionnaire about how a skin condition affects day-to-day life). The reported data shows that out of 18 participants, 14 had a reduction in their PASI score at the 4-week mark. Separately, the reported data also shows that 14 out of 18 participants had a reduction in their DLQI score at 4 weeks. It is worth noting that the data as submitted does not report the actual size of those reductions — only whether a reduction occurred — so those figures are not available here. It is also important to note that this was a small, single-group study with no comparison group, which limits what can be drawn from the numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT06357221 · results posted 9 June 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT06357221) enrolled 46 people who had psoriasis, all of whom used a skincare product as the single treatment being tested. Of the 46 who started, 41 completed the trial and 5 did not finish. The trial tracked several things over time: how much body surface area was affected by psoriasis (using a "handprint" method, where one handprint equals roughly 1% of the body's skin), how severe a specific target patch of psoriasis looked (scored on a 0–24 scale), how a doctor rated the overall psoriasis severity (scored 0–5), how scaly and smooth the skin appeared under a specialised imaging device, and how satisfied participants felt with the treatment. The reported data shows that scores on all the measured scales went down over the course of the study — and for these measures, lower numbers mean less psoriasis or less severe skin changes. Body surface area affected started at a reported average of 9.3% and came down to 5.1% by the final time point. The target lesion severity score started at around 10.85 (out of a possible 24) and was reported at 3.51 by the end. The doctor's overall severity rating started at 2.67 (out of 5) and was reported at 1.37 at the last check. The imaging measurements for scaliness and smoothness also showed lower numbers over time. For participant satisfaction, the reported data shows that out of 41 completers, the number giving favourable responses across nine different satisfaction questions ranged from 33 to 40 participants, though the specific questions behind each number were not detailed in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT05364554 · results posted 1 June 2026
According to the results reported on ClinicalTrials.gov, this trial involved 227 people with psoriasis across six groups, each receiving a different dose or dosing schedule of an investigational tablet called JNJ-77242113, or a placebo that was later switched to the active treatment. The groups ranged in size from 35 to 40 participants at the start, and between 27 and 35 in each group completed the study. The trial measured how participants' psoriasis changed after 36 weeks of a long-term extension period, using several standardised scoring tools that assess the severity and extent of skin plaques, as well as self-reported symptoms such as itch, pain, and burning. The reported data shows that, for the primary measure — the proportion of participants whose psoriasis severity score (called PASI) improved by at least 75% from their starting point — the figures ranged from 48.8% in the lowest-dose group to 76.2% in the highest-dose group (100 mg twice daily). For a more stringent target of at least 90% improvement, the reported figures ranged from 27.9% to 64.3% across the groups, and for complete clearance on this scale, between 14.0% and 40.5% of participants were recorded as reaching that mark. A separate doctor-assessed skin score (IGA) showed between 37.2% and 73.8% of participants across groups reached a rating of "cleared" or "minimal." On a patient-reported symptom scale (0–100, where higher means more severe), all groups showed a reduction from their starting scores, with changes ranging from −29.4 to −47.7 points at week 36. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT06095115 · results posted 1 June 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 684 participants with plaque psoriasis — 228 in the placebo group and 456 in the JNJ-77242113 200 mg group. The trial was measuring how participants' skin responded over 16 weeks using two main scoring tools: the IGA (Investigator's Global Assessment), which rates overall skin clearance on a scale from 0 (completely clear) to 4 (severe), and the PASI (Psoriasis Area and Severity Index), which scores the extent and severity of psoriasis across the body on a scale of 0 to 72. The trial also tracked responses at earlier time points and continued follow-up through to week 52. The reported data shows that at week 16, 64.7% of participants in the JNJ-77242113 group had their IGA score reach 0 (clear) or 1 (minimal) with at least a 2-point improvement from their starting score, compared with 8.3% in the placebo group. For the second primary measure, 49.6% of the JNJ-77242113 group showed at least a 90% improvement in their PASI score by week 16, compared with 4.4% in the placebo group. For the secondary outcomes, the reported data shows that 33.3% of the JNJ-77242113 group achieved a completely clear IGA score of 0 at week 16, versus 1.3% on placebo. Looking at earlier time points, 14.9% of the treatment group achieved a 75% or greater PASI improvement by week 4, rising to 21.5% achieving a 90% or greater PASI improvement by week 8, and 69.1% achieving a 75% or greater PASI improvement by week 16 — compared with 2.2%, 1.3%, and 11.0% respectively in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT05357755 · results posted 5 May 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 89 people with psoriasis across three groups: 24 received a placebo (a dummy pill with no active ingredient), 31 received a lower dose of the investigational pill JNJ-77242113 (10 mg once daily), and 34 received a higher dose (50 mg once daily). The trial ran for 16 weeks and was primarily measuring how many participants saw their psoriasis severity score — called the PASI score, a standardised 0–72 scale where higher numbers mean more severe psoriasis — improve by at least 75% from where it started. The reported data shows that for the main measurement at 16 weeks, 4.2% of placebo participants, 41.9% of those on the lower dose, and 73.5% of those on the higher dose reached that 75%-or-better improvement mark. For an even greater improvement of 90% or more, the reported figures were 0% (placebo), 25.8% (lower dose), and 52.9% (higher dose). Complete clearance of the score (100% improvement) was reported in 0% of the placebo group, 9.7% on the lower dose, and 23.5% on the higher dose. Separately, a doctor's overall skin assessment (rated 0–4, where 0 means completely clear) found that a score of "cleared or minimal" was reached by 4.2% on placebo, 41.9% on the lower dose, and 73.5% on the higher dose, while a "completely cleared" rating was reported in 0%, 12.9%, and 29.4% respectively. The reported average change in total PASI score from the starting point was −4.30 for placebo, −11.56 for the lower dose, and −16.84 for the higher dose. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT06042920 · results posted 17 April 2026
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called deucravacitinib (also referred to in the trial as BMS-986165) in people with two specific types of psoriasis — psoriasis affecting the palms and soles of the feet (called palmoplantar psoriasis), and psoriasis affecting the genital area. The trial had two phases: a placebo-controlled phase (where some participants received the active medicine and others received a dummy treatment with no active ingredient) and an active treatment phase (where all participants received the medicine). In the placebo-controlled phase, 30 people with palmoplantar psoriasis received the medicine, 15 received the placebo, 56 people with genital psoriasis received the medicine, and 29 received the placebo. The reported data shows two main things were measured. For palmoplantar psoriasis, the trial measured how many people achieved at least a 75% improvement in a standard skin severity score — 31.3% of those on the medicine reached this level, compared with 33.3% of those on the placebo. For genital psoriasis, the trial measured how many people's skin was rated as "clear" or "almost clear" by a doctor — 48.4% of those on the medicine reached this rating, compared with 0% of those on the placebo. A secondary measure looked at a self-reported itch score for genital psoriasis (on a 0–10 scale): those on the medicine reported an average decrease of 1.9 points from their starting score, compared with a decrease of 0.8 points for the placebo group. The reported data also shows that during the placebo-controlled phase, 17 of 30 palmoplantar participants and 31 of 56 genital participants on the medicine experienced at least one adverse event (an unwanted medical occurrence during the study period); one serious adverse event was recorded among genital psoriasis participants on the medicine, and none in the other groups. Two participants in the genital psoriasis medicine group had severe laboratory test abnormalities recorded, while none were recorded in the other groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT05366855 · results posted 27 March 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05366855) was a follow-on maintenance study involving 42 participants in total across eight different groups. People who had taken part in an earlier trial of imsidolimab (a medicine being investigated for Generalised Pustular Psoriasis, or GPP — a rare and serious skin condition) were placed into groups depending on how they had responded previously and what treatment they received in this study. The study was measuring how often unwanted health events (called adverse events) occurred, and tracking whether participants' skin disease stayed under control over time. The reported data shows that for the primary outcome — counting how many people in each group experienced any adverse event — the numbers ranged from 0 to 8 participants depending on the group, out of group sizes of 0 to 9 people. For the secondary outcomes, the reported data shows that 100% of participants in the double-blind imsidolimab injection group maintained a skin disease score of 0 or 1 (meaning "clear" or "almost clear" on the doctor's rating scale), compared with 64.4% in the placebo group. Regarding flare-ups (defined as the disease returning to a moderate or severe rating), 100% of participants in the imsidolimab group had no recorded flare recurrence during the study, compared with 63.3% in the placebo group. For the time until a first flare recurrence, a median figure was not reached for the imsidolimab group (meaning not enough participants had a flare for a midpoint to be calculated), while it was reported as 42.3 weeks for the placebo group. It is worth noting that the group sizes in this trial were very small, and the reported completion data shows that most participants did not complete the study as initially planned. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT05352893 · results posted 17 March 2026
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called imsidolimab for people with a serious skin condition called generalised pustular psoriasis (GPP), which causes widespread painful pus-filled spots. Forty-five people took part in total — 15 received a higher dose of imsidolimab (750 mg), 15 received a lower dose (300 mg), and 15 received a placebo (a dummy treatment with no active medicine). The main thing the trial was measuring was how many people's skin was rated as "clear" or "almost clear" by their doctor using a standard 5-point scoring tool, where 0 means clear and 4 means severe. Not everyone finished the trial — 11, 12, and 5 people completed it in the higher-dose, lower-dose, and placebo groups respectively. The reported data shows that for the main measure, 8 out of 15 people in the higher-dose group and 8 out of 15 in the lower-dose group had their skin rated as clear or almost clear by their doctor, compared with 2 out of 15 in the placebo group. For the secondary measure — which looked specifically at the severity of the pus-filled spots using a separate but similar 5-point scoring tool — the reported data shows 6 out of 15 in the higher-dose group and 10 out of 15 in the lower-dose group were rated clear or almost clear for pustules, compared with 2 out of 15 in the placebo group. No other outcome data was included in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT06011733 · results posted 20 February 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT06011733) enrolled 133 adults with moderate to severe psoriasis. Participants were split into two groups: 33 people who started on a placebo (an inactive treatment) before switching to the medicine bimekizumab, and 100 people who received bimekizumab from the start. The trial was measuring how much psoriasis improved over time using two main scoring tools — a detailed skin assessment called the PASI score (which rates redness, thickness, and scaling across the body on a scale where 0 means no disease and 72 means the most severe possible), and a doctor's overall impression rating called the IGA (scored 0 to 4, where 0 is clear skin and 4 is severe). The reported data shows that by Week 16, in the group receiving bimekizumab, 94% of participants had at least a 90% improvement in their PASI score, compared to 3% in the placebo group. Similarly, 92% of the bimekizumab group received a score of 0 or 1 (clear or almost clear) on the doctor's IGA rating, compared to 3% in the placebo group. The reported data also shows that by Week 16, 65% of the bimekizumab group had a 100% improvement in their PASI score, versus 0% in the placebo group, and by as early as Week 4, 74% of the bimekizumab group had achieved at least a 75% improvement in their PASI score, compared to 3% on placebo. For additional measures looking at how participants felt day-to-day, the reported data shows that at Week 16, 84.1% of people in the bimekizumab group reported a meaningful reduction in itch (at least a 4-point drop on a 0–10 scale), compared to 8% in the placebo group. For pain, 86.1% of the bimekizumab group reported a meaningful reduction, compared to 14.3% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04246372 · results posted 11 December 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 47 participants who were already receiving tofacitinib (a tablet medicine) as part of their usual care for one of five immune-related skin conditions: alopecia areata (patchy hair loss), atopic dermatitis (eczema), vitiligo, psoriasis, or hidradenitis suppurativa. Forty-two of the 47 participants completed the study. The trial was primarily measuring two things over 16 weeks: any serious unwanted events that were definitely caused by tofacitinib, and changes in a molecular measure called an "Interferon Score" — a laboratory calculation based on the activity of 16 genes in the blood that reflects how active a particular immune pathway is. The reported data shows that zero serious unwanted events were recorded as definitely linked to tofacitinib during the study period. For the Interferon Score, the reported average change was −8.41 points at 16 weeks, meaning the score went down on average (noting that no threshold for what a change in this score means clinically has been established). For the secondary measures, the reported data shows an average change of −1.31 points on a doctor-rated skin severity scale (where lower is less severe), and an average change of −2.88 points on a quality-of-life questionnaire scored out of 30 (where lower means less impact on daily life). Among participants with alopecia areata, the reported average change on the hair-loss measurement scale was −28.10 points at 16 weeks. The eczema-specific score was not reported in the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04936308 · results posted 8 December 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04936308) enrolled 453 people in total across three groups: 150 who started on a placebo and later switched to guselkumab 100 mg, 152 who received guselkumab 100 mg every 8 weeks, and 151 who received guselkumab 100 mg every 4 weeks. The trial was measuring outcomes in people with psoriatic arthritis — a condition involving joint inflammation alongside the skin condition psoriasis. The main thing the trial was tracking was whether participants' joint symptoms improved by at least 20% (a standard measure called an ACR 20 response) by week 24. The reported data shows that at week 24, around 35.9% of people in the placebo-then-guselkumab group met that joint improvement threshold, compared with 63.0% in the every-8-weeks guselkumab group and 60.9% in the every-4-weeks guselkumab group. For skin-related measures (among those with meaningful skin involvement at the start), the reported data shows that roughly 18.8% of the placebo group, 60.7% of the every-8-weeks group, and 56.8% of the every-4-weeks group showed a significant clearing or near-clearing of their skin at week 24. A separate skin score measuring at least 90% improvement in psoriasis severity was reported for 12.5%, 47.6%, and 54.9% of participants in each respective group. The reported data also shows changes in physical function, quality of life, and fatigue scores at week 24. On the physical function questionnaire (where a lower score means less difficulty), the placebo group's score decreased by 0.24 points on average, while the every-8-weeks and every-4-weeks guselkumab groups decreased by 0.40 and 0.42 points respectively. On the physical quality-of-life measure (where a higher score means better quality of life), average scores increased by 3.7, 7.0, and 7.0 points across the three groups. On the fatigue questionnaire (where a higher score means less fatigue), average scores increased by 3.9, 7.8, and 8.4 points respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT05730725 · results posted 25 November 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 109 people in total across four groups — a placebo group (28 people) and three treatment groups (27 people each). The trial was studying a treatment for moderate-to-severe psoriasis, a skin condition. The main things being measured were how much participants' psoriasis skin scores improved after 12 weeks, and information about unwanted health events that occurred during the trial. Most participants completed the study: 24 out of 28 in the placebo group, and 25–26 out of 27 in each treatment group. The reported data shows that the main skin score measurement used was called the PASI — a scale from 0 to 72 where higher numbers mean more severe psoriasis. One key goal was to see how many participants achieved at least a 75% reduction in their PASI score by week 12 (called "PASI-75"). In the placebo group, 3.6% of participants reached this level of reduction. In Treatment 1, Treatment 2, and Treatment 3, the reported figures were 47.8%, 80.8%, and 63.0% respectively. For a less stringent measure — a 50% reduction in PASI score — the reported figures were 17.9% (placebo), 73.9% (Treatment 1), 92.3% (Treatment 2), and 81.5% (Treatment 3). A doctor's overall skin assessment score of 0 or 1 (meaning clear or nearly clear skin) at week 12 was reported in 3.6% of the placebo group, compared with 54.2%, 69.2%, and 55.6% across the three treatment groups. The reported data also shows that unwanted health events during the trial were tracked carefully. In terms of events considered related to treatment, 16 people in the placebo group and 14 each in Treatment 1 and Treatment 2, and 16 in Treatment 3 experienced such events. Serious unwanted health events were reported in 1 person each in the placebo and Treatment 1 groups, and none in Treatment 2 or Treatment 3. No participants experienced what were classified as severe unwanted health events in any group, though mild and moderate events were recorded across all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04271540 · results posted 25 November 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people who had psoriasis (a skin condition) and were treated with a medicine called tildrakizumab. The trial was measuring how the drug affected blood flow in the heart's arteries — specifically something called "coronary flow reserve" (CFR), which is a way of measuring how well the heart's blood vessels can increase blood flow when the body needs more. Thirty participants completed the study, and six did not finish. There was only one group in this trial — everyone received the treatment, so there was no comparison group. The reported data shows that after 24 weeks of treatment, the average change in coronary flow reserve was −0.03 (on a ratio scale). In plain terms, this means the average reading was almost the same as it was at the start of the trial — a very small decrease. The reported data also shows a small average increase of 0.07 ml/min/g in peak blood flow through the heart muscle during stress, and an average decrease of 1.1 units in the resistance the heart's blood vessels put up during stress. A secondary measure looked at whether changes in heart blood flow were linked to improvements in psoriasis skin scores; the reported figure (a correlation score of 0.18, where 0 means no link and 1 means a perfect link) suggests only a weak relationship between the two, though it is important to note that correlation scores alone do not tell us whether one thing caused a change in the other. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT06176768 · results posted 15 October 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT06176768) enrolled 33 people with psoriasis — 16 received the investigational medicine LY3972406 and 17 received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring how many participants achieved at least a 75% reduction in their psoriasis severity score (called PASI-75), a standard way of tracking how much psoriasis improves. The trial was terminated early, with only 3 participants in the LY3972406 group and 4 in the placebo group completing the full study period. The reported data shows that 18.8% of participants taking LY3972406 reached the PASI-75 target, compared with 5.9% of those on placebo. For the secondary measures, the LY3972406 group showed an average reduction of 7.26 percentage points in the amount of body surface area affected by psoriasis, while the placebo group showed a reduction of 0.48 percentage points. A quality-of-life questionnaire (scored 0–30, where lower scores mean less impact on daily life) showed an average reduction of 6.71 points in the LY3972406 group and 4.35 points in the placebo group. The reported data also shows that the average blood concentration of LY3972406 measured in participants was 158 nanograms per millilitre (a very small unit of measurement used to track how much of a medicine is present in the blood). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT05811234 · results posted 24 September 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 291 adults who used a cream called CAL/BDP PAD Cream — a combination topical treatment applied to the scalp — for scalp psoriasis. Of those who started, 265 completed the trial. The study measured how satisfied participants were with the medication (using a questionnaire called TSQM-9), how the condition affected their quality of life and itch levels (using tools called Scalpdex and WI-NRS), and how many participants' scalps were rated as "clear" or "almost clear" by a doctor (called Scalp-PGA treatment success). The reported data shows that at 12 weeks, participant satisfaction scores on the TSQM-9 — which runs from 0 to 100, where higher means more satisfied — were 73.56 for effectiveness, 72.07 for convenience, and 75.97 for overall (global) satisfaction. For quality of life, the Scalpdex questionnaire scores — where lower numbers mean a better quality of life — were reported as 22.66 for symptoms, 29.53 for emotions, and 26.88 for day-to-day functioning. Regarding itch (scored 0 to 10, where 10 is the worst imaginable), the reported data shows a starting score of 6.43, which came down to 2.66 by week 12. For the doctor's assessment, 48% of participants were rated as treatment successes at week 4, rising to 68.4% at week 12. It is worth noting that this trial had only one group — everyone used the same cream — so there was no comparison group receiving a different or dummy treatment, which means the reported numbers reflect what was observed in this single group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03897075 · results posted 6 June 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 99 people in total — 48 received a placebo (a dummy treatment with no active ingredient) and 51 received a medicine called tildrakizumab at a dose of 100 mg. The trial was looking at nail psoriasis, a condition where psoriasis affects the fingernails or toenails. The main thing researchers were measuring was how many participants saw their nail psoriasis score (using a scale called the mNAPSI) improve by at least 75% after 28 weeks of treatment. By the end of the study, 35 people in the placebo group and 43 in the tildrakizumab group had completed the trial. The reported data shows that at the 28-week mark, about 4.2% of people in the placebo group reached that 75% improvement target, compared with about 25.5% of people in the tildrakizumab group. For the secondary measures, the reported data shows that roughly 4.2% of placebo participants and 29.4% of tildrakizumab participants achieved a near-normal or minimal nail psoriasis rating on a separate assessment tool (called ViSENPsO). Among those who started the trial with notable nail pain, about 25.7% of the placebo group and 45.5% of the tildrakizumab group reported at least a 3-point reduction in their pain score. The trial also tracked adverse events (unwanted health events that occurred during the study). The reported data shows that 39.6% of placebo participants and 54.9% of tildrakizumab participants experienced any adverse event over the course of the study. Serious adverse events were reported in 4.2% of the placebo group and 5.9% of the tildrakizumab group. No participants in either group were reported to have had a severe infection requiring hospital-level antibiotic treatment, and no malignancies (cancers, excluding a specific cervical condition) were reported in the tildrakizumab group, compared with 2.1% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
-
NCT04717466 · results posted 5 June 2025
According to the results reported on ClinicalTrials.gov, this trial involved 20 people in total — 10 with psoriasis and 10 without (referred to as the healthy group). All 20 participants completed the study. The trial was looking at whether there were any differences in brain structure and brain activity between the two groups, and whether these changed over a four-week period. For the psoriasis group, researchers also tracked itch, pain, and skin severity scores, as well as overall wellbeing for both groups. The reported data shows the following changes from the start of the study to week four. For brain structure (measured by looking at the density of brain tissue on MRI scans), the reported change was zero for both groups, meaning no change was recorded. For brain activity (measured by tracking blood flow in the brain), the psoriasis group showed a change of +1 unit, while the healthy group showed a change of −18 units — the units here represent millilitres of blood per 100 grams of brain tissue per minute. For the psoriasis group only, itch scores (on a 0–10 scale) changed by 3 points, pain scores changed by 2 points, and skin severity scores (on a 0–100 scale) changed by 8 points. For overall wellbeing (on a 0–25 scale, where higher means better wellbeing), the psoriasis group showed a change of 2 points and the healthy group showed a change of 0 points. The reported data does not indicate whether these changes represent increases or decreases from baseline. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT05195814 · results posted 30 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05195814) enrolled 141 people with psoriatic arthritis — 66 in a group taking tofacitinib on its own, and 75 in a group taking tofacitinib together with another medicine called OSM (a combination therapy). All 141 participants completed the study. The trial was measuring several things over six months: how many joints were tender or swollen, whether participants reached a state of low or minimal disease activity, how much skin was affected by psoriasis, and whether a specific type of joint-area inflammation (called enthesitis) had resolved. The reported data shows the following across the key measurements at six months. For tender joints (checked across 68 joints), the overall group showed an average reduction of 2.5 joints from their starting count — 3.2 for the monotherapy group and 2.0 for the combination group. For swollen joints (checked across 66 joints), the overall average reduction was 1.6 joints — 2.2 for monotherapy and 1.1 for combination. Regarding minimal disease activity (a threshold where most symptoms are well controlled by several measures at once), 17.8% of all participants reached that level overall — 15.0% in the monotherapy group and 20.7% in the combination group. For skin coverage by psoriasis, 24.7% of all participants had no skin affected at six months (27.1% monotherapy; 22.0% combination). Using a broader disease activity scoring tool (PASDAS, which combines joint, skin, and function measures into a single score), 21.8% of all participants scored in the low disease activity range — 21.1% monotherapy and 22.5% combination. Finally, of those who had enthesitis at the start, 35.2% overall had it resolve by six months — 33.3% in the monotherapy group and 36.7% in the combination group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03451851 · results posted 28 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03451851) looked at plaque psoriasis in children and adolescents. In the first part of the trial (weeks 0 to 16), participants were split into three groups: 25 received a placebo (an inactive treatment), 41 received guselkumab, and 26 received etanercept. A separate second part of the trial also enrolled 28 additional participants who received guselkumab. The trial measured how much participants' psoriasis improved using two main tools: a doctor's overall rating of skin clearance (called the IGA, scored from 0 = clear skin to 4 = severe), and a detailed scoring system covering how much of the body was affected and how severe the patches were (called PASI, scored from 0 to 72, where higher means more severe). The reported data shows that at week 16, 65.9% of participants in the guselkumab group and 69.2% in the etanercept group had skin rated as "cleared" or "minimal" on the doctor's scale, compared with 16.0% in the placebo group. For the PASI measure, 75.6% of the guselkumab group and 69.2% of the etanercept group showed at least a 75% improvement in their skin score from the start of the trial, compared with 20.0% in the placebo group. The reported data also shows that for the secondary measures at week 16: at least a 90% improvement in PASI score was reported for 56.1% (guselkumab), 53.8% (etanercept), and 16.0% (placebo); complete clearance of the skin score was reported for 39.0% (guselkumab), 26.9% (etanercept), and 4.0% (placebo); and a 100% improvement in PASI was reported for 34.1% (guselkumab), 26.9% (etanercept), and 0% (placebo). A quality-of-life questionnaire for children (scored 0–30, where lower means less impact on daily life) showed average reductions from the starting score of 7.12 points in the guselkumab group, 6.08 points in the etanercept group, and 1.68 points in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04908514 · results posted 11 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04908514) looked at a treatment called ADX-629 for psoriasis. Ten people started the study, seven completed it, and three did not finish. The trial was mainly measuring changes in psoriasis severity using a standard scoring tool called the Psoriasis Area and Severity Index (PASI), which runs from 0 (no psoriasis) to 72 (maximum severity). A second scoring tool, the Investigator's Global Assessment (IGA), was also used — this runs from 0 (clear skin) to 4 (severe). The reported data shows that, for the PASI score, the average change from the starting point was recorded at three different time points during the study: scores dropped by 4.3 points, then 7.6 points, and then 8.0 points from where participants began (lower numbers mean less severe psoriasis on this scale). For the IGA score, the reported average changes from the starting point across three time points were drops of 0.50, 0.68, and 0.85 points. The reported data also shows that, of the participants assessed at week 12, 3 out of the group had their PASI score reduce by at least 50% from their starting point, and 2 out of the group had it reduce by at least 75%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03047395 · results posted 11 December 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03047395) enrolled 2,170 people who were all given risankizumab 150 mg. Of those who started, 1,601 completed the study and 569 did not finish. The trial's main focus was on tracking and recording adverse events — that is, any unwanted or unexpected medical occurrences that happened during the study, whether or not they were thought to be related to the medication. The reported data shows two categories of adverse events were counted. A serious adverse event was defined as something that caused death, was life-threatening, required a hospital stay, caused lasting disability, or was otherwise judged to be a significant medical concern. A non-serious adverse event covered any other unwanted medical occurrence. According to the figures submitted, 435 participants were reported to have experienced serious adverse events, and 1,215 participants were reported to have experienced non-serious adverse events during the study period. No other outcome measures were included in the submitted results data. It is worth noting that recording adverse events is a standard part of clinical trials and does not on its own tell us whether a treatment is beneficial or harmful — it simply documents what medical events occurred and how often. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03598790 · results posted 6 December 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03598790) looked at a medicine called bimekizumab (BKZ) in people with different forms of psoriasis — a skin condition. Participants were placed into groups depending on their type of psoriasis and how often they received the medicine (either every four weeks or every eight weeks). In total, more than 1,300 people took part across the main treatment period and a follow-up extension phase. The trial measured how often unwanted health events (called adverse events) occurred, as well as how much participants' skin improved over time, with assessments running up to around three years. The reported data shows that the rate of any treatment-emergent adverse event (that is, any unwanted health event that appeared after starting the medicine) varied across the groups, ranging from about 74 to 328 new events per 100 patient-years — a way of accounting for the fact that people were in the trial for different lengths of time. Serious adverse events (those considered more significant medically) were reported at rates ranging from roughly 4 to 20 per 100 patient-years across the groups. Adverse events that led someone to stop taking the medicine were reported at rates of approximately 1 to 8 per 100 patient-years depending on the group. For skin improvement, the reported data shows that at around the three-year mark (week 144), between approximately 73% and 90% of participants in the various psoriasis groups achieved at least a 90% reduction in their skin disease score (a measure called PASI90), depending on which group they were in. Separately, between approximately 60% and 79% of participants in certain groups were rated by their doctor as having clear or almost clear skin at that same time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03706209 · results posted 22 November 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03706209) looked at a medicine called MP1032 for people with psoriasis, a skin condition. A total of 155 people started the trial across three groups: 52 people took a lower dose of MP1032 (150 mg twice daily), 48 took a higher dose (300 mg twice daily), and 55 took a placebo (a dummy treatment with no active ingredient). By the end of the study, 36, 39, and 39 people respectively had completed the trial in each group. The trial measured two main things after 12 weeks: how many people's psoriasis skin scores improved by at least 75% (called PASI 75), and how many people's doctors rated their overall skin condition as improved (called PGA improvement). The reported data shows that for the PASI 75 measure — meaning at least a 75% reduction in the psoriasis skin score — 4 out of 46 participants in the lower-dose group and 4 out of 43 in the higher-dose group reached this point, compared with 1 out of 53 in the placebo group. For the doctor's overall rating (PGA), 14 out of 36 in the lower-dose group and 14 out of 33 in the higher-dose group showed at least a one-point improvement, compared with 10 out of 44 in the placebo group. A separate measure looked at a 50% improvement in skin scores (PASI 50): 8 out of 42 in the lower-dose group and 10 out of 37 in the higher-dose group reached this, versus 6 out of 48 in the placebo group. The reported data also shows that when looking at the average change in psoriasis skin scores from the start of the trial to week 12, the lower-dose group had an average change of +0.1 (a very slight increase), the higher-dose group had an average change of −1.1 (a slight decrease), and the placebo group had an average change of −0.1 — noting that a negative number indicates a lower skin score, which is considered a better result on this scale. Additional analyses in a smaller subset of participants (called the "valid cases set") showed broadly similar patterns across both the skin score and doctor's rating measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03726489 · results posted 19 September 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03726489) enrolled 390 people in an office-based light therapy (phototherapy) group and 393 people in a home-based light therapy group — 783 participants in total. The trial was studying phototherapy for psoriasis, comparing treatment received at a clinic versus treatment done at home. It measured two main things: how many participants' skin was rated as "clear" or "almost clear" by a doctor (using a scoring tool called the Physician Global Assessment, or PGA), and how many participants reported that psoriasis had little or no impact on their daily life (using a quality-of-life questionnaire called the DLQI). The reported data shows that, for the skin clearance measure, 100 participants in the office-based group and 129 in the home-based group achieved a "clear or almost clear" rating at some point during the study — though not all participants were assessed at every time point. For the quality-of-life measure, 131 participants in the office-based group and 206 in the home-based group scored in the range indicating little or no impact on daily life. For the secondary measures, the reported data shows that home-based participants recorded a higher average number of treatment sessions (around 27 sessions on average, compared to around 18 for the office-based group) and received a higher cumulative light dose overall. The reported data also shows that office-based participants used topical (applied to the skin) psoriasis medications on roughly 3.9 days per week on average, compared to around 3.1 days per week for the home-based group. A small number of participants in both groups started or stopped oral or biologic (injected or infused) psoriasis treatments during the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02984020 · results posted 27 August 2024
According to the results reported on ClinicalTrials.gov, this was a post-marketing surveillance study of Xeljanz (tofacitinib) — meaning it was designed to track what happened to patients already using the medicine in routine clinical practice, rather than testing it against a comparison group. A total of 1,041 people were enrolled, 1,009 of them completed the study, and 32 did not finish. The study was focused entirely on monitoring and recording any medical events that occurred while participants were taking Xeljanz. The reported data shows that out of 1,041 participants, 261 experienced at least one adverse event (an unexpected or unwanted medical occurrence of any kind). Of those, 148 were considered adverse drug reactions — meaning a doctor judged them to be linked to Xeljanz. Forty participants experienced a serious adverse event (one serious enough to cause hospitalisation, be life-threatening, or result in lasting harm), and 20 of those were considered serious adverse drug reactions. Separately, 21 participants had an unexpected adverse event (meaning the event differed in some way from what was already known about the medicine), and 16 had an unexpected adverse drug reaction. Looking at how severe the adverse events were: 201 participants had mild events, 82 had moderate events, and 7 had severe events. In terms of how those events resolved: 200 participants recovered fully, 43 were still recovering at the time of reporting, 38 had not recovered, 1 recovered with lasting effects, and for 7 the outcome was unknown. The reported data also shows the average duration of an adverse event was 26 days, though this figure was only based on participants for whom that information was available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00563524 · results posted 23 August 2024
According to the results reported on ClinicalTrials.gov, this trial tested an investigational drug called ILV-094 across six groups of participants. A total of 76 people took part — split across four ILV-094 dose groups (given either by injection under the skin or directly into a vein) and two placebo groups (one for each delivery method). The trial was primarily focused on monitoring participants for any medical events or notable changes in their heart readings, vital signs (such as blood pressure and heart rate), and blood and urine test results during and after treatment, up to around 18 weeks. It also measured how much of the drug was absorbed into participants' bloodstreams. The reported data shows that when it came to general medical events (called adverse events), the number of participants who experienced at least one such event ranged from 3 out of 13 in the lower-dose injection group up to 11 out of 12 in the lower-dose intravenous group, with the placebo groups reporting 7 and 9 participants respectively. Serious adverse events — meaning more significant medical occurrences — were reported in 2 participants in the higher-dose intravenous group and none in any other group. For heart trace (ECG) changes meeting pre-set thresholds, between 2 and 4 participants were recorded across all groups. Notable changes in vital signs affected between 0 and 5 participants per group, and laboratory test results of potential concern were seen in 7 to 10 participants across the groups. Regarding how much drug reached the bloodstream, the reported peak blood concentration figures were higher at larger doses and when given intravenously compared to injections under the skin. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT05789576 · results posted 9 August 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 31 participants, all of whom used VTAMA (tapinarof) cream 1%. The trial was looking at a cream applied to psoriasis patches on the head and neck. The main thing being measured was how many participants reached a score of "clear" or "almost clear" on a standardised 5-point skin assessment scale (called the Physician Global Assessment, or PGA), while also improving by at least 2 steps on that scale from where they started. Of the 31 who began the trial, 24 completed it and 7 did not. The reported data shows that 23 out of 31 participants reached the "clear" or "almost clear" target on the PGA scale for their head and neck lesion, with at least a 2-grade improvement. The trial also tracked how long it took participants to reach that point. According to the results reported on ClinicalTrials.gov, the reported figure for time to reach that assessment level was 29 days (just under a month), on average. No other outcome figures were included in the submitted data beyond these two measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01947933 · results posted 25 July 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT01947933) tested a drug called LY3074828 (also known as mirikizumab) against a placebo (a dummy treatment with no active ingredient). A total of 45 people took part across nine groups — one placebo group of 7 people, and eight groups of around 3–5 people each who received different doses of LY3074828, either by intravenous drip (into a vein) or by subcutaneous injection (under the skin). The trial was primarily measuring how many participants in each group experienced unwanted side effects that the study doctors believed were related to the study drug. It also measured how the drug moved through the body over time — specifically, how much of the drug was present in the bloodstream and what the highest concentration reached was. The reported data shows that, for the primary measure, the number of participants who experienced side effects considered by the doctors to be related to the study drug varied across groups: 1 person in the placebo group, 1 in the 5 mg group, 2 in the 20 mg group, none in the 60 mg and 120 mg intravenous groups, 3 in the 120 mg under-the-skin group, 1 in the 200 mg group, and none in the 350 mg and 600 mg groups. For the body-concentration measurements, the reported data shows that the peak drug level in the blood (the highest point reached) ranged from 1.60 micrograms per millilitre in the lowest dose group up to 220 micrograms per millilitre in the highest dose group. The total overall exposure to the drug over time also increased with higher doses, ranging from 33.6 to 1,360 micrograms•day per millilitre across the intravenous dose groups. The 5 mg group's overall exposure figure was listed as not available in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT05680740 · results posted 8 July 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 34 people with psoriasis affecting skin fold areas (such as the groin, armpits, or under the breasts — known as "intertriginous" areas). All participants used VTAMA® (tapinarof) cream 1%. Of the 34 who started, 28 completed the trial and 6 did not finish. The trial was primarily measuring how many participants reached a doctor-rated score of "clear" or "almost clear" on a five-point skin assessment scale, where a score of 0 means no visible psoriasis and 4 means severe psoriasis. It also tracked how long it took participants to reach that level of improvement. The reported data shows that 24 out of 34 participants reached the main goal — a score of "clear" (0) or "almost clear" (1) on the skin assessment, with at least a two-point improvement from where they started. For the secondary measure, the reported data shows that the median time (meaning the middle value when all individual times are lined up in order) for participants to reach that level of improvement was 45 days. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01010542 · results posted 3 July 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT01010542) looked at a treatment called ILV-095 for psoriasis — a skin condition. A total of 39 people started the trial: 1 person received the lower dose (100 mg), 30 received the higher dose (300 mg), and 8 received a placebo (a dummy treatment with no active ingredient). The main thing the trial was measuring was the proportion of participants whose psoriasis skin score — called the PASI score, a standard 0–72 scale where higher numbers mean more severe disease — improved by at least 50% compared to their starting point, checked at weeks 2, 4, 6, and 8. The reported data shows the following results for the percentage of participants reaching that 50% improvement target: at Week 2, 0% of the 100 mg group, 13.8% of the 300 mg group, and 14.3% of the placebo group reached this threshold; at Week 4, the figures were 0%, 28.6%, and 28.6% respectively; at Week 6, 0%, 25.0%, and 33.3%; and at Week 8, 0%, 33.3%, and 16.7%. The trial also tracked two other measures — a lesion severity score (rated 0–12) and a physician's overall rating of psoriasis (rated 0–4) — across all four time points, with the reported data showing scores generally declining over time across all groups. It is worth noting that only 1 person was in the 100 mg group, so those figures carry very little weight on their own. The reported data shows that this was a small trial, and the numbers across groups should be interpreted with that limitation in mind. No conclusions about whether ILV-095 performed differently from placebo can be drawn from this summary alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT05268016 · results posted 27 June 2024
According to the results reported on ClinicalTrials.gov, this trial tested four different doses and dosing schedules of an investigational treatment called ME3183 in people with psoriasis. A total of 132 participants were enrolled across the five groups — four ME3183 groups (26–27 people each) and one placebo group (27 people). Not everyone finished the trial: between 14 and 18 people completed it in each ME3183 group, and 16 completed it in the placebo group. The main thing the trial was measuring was how many participants saw their psoriasis severity score (called the PASI score, a standard scale from 0 to 72 where higher means more severe disease) drop by 75% or more after 16 weeks. The reported data shows that at week 16, the share of participants reaching that 75%-reduction mark varied across groups. In the ME3183 groups, the figures were: Dose 1 (twice daily) — 58.3%; Dose 2 (once daily) — 32.0%; Dose 3 (twice daily) — 61.5%; and Dose 4 (once daily) — 52.0%. In the placebo group, the reported figure was 14.8%. The trial also tracked unwanted health events (called adverse events) that occurred during or after treatment. The reported data shows that the number of participants who experienced any such event ranged from 16 to 24 across the ME3183 groups and was 16 in the placebo group. Serious adverse events — meaning events considered potentially life-threatening or requiring hospitalisation — were reported for 1 participant in the Dose 2 ME3183 group and 1 participant in the placebo group, with none reported in the other groups. No clinically significant abnormalities in physical examination findings or vital signs (such as blood pressure or heart rate) were reported for any participant in any group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04713592 · results posted 14 June 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04713592) involved 174 adults with palmoplantar psoriasis — a form of psoriasis affecting the palms of the hands and soles of the feet. Participants were randomly assigned to receive either the drug risankizumab (87 people) or a placebo — an inactive treatment (87 people) — for the first 16 weeks. After that, all participants who completed this first phase moved into an open-label period (where everyone received risankizumab) running from week 16 to week 52. The trial was measuring how much the psoriasis on participants' hands and feet improved, using several scoring tools rated by doctors, as well as tracking any unwanted medical events that occurred during the trial. The reported data shows that by week 16, 33.3% of participants in the risankizumab group had their doctor rate their skin as "clear" or "almost clear" on the main scoring scale (ppIGA), compared with 16.1% in the placebo group. Using a separate area-and-severity scoring tool (PPASI), the reported data shows that 42.5% of the risankizumab group achieved at least a 75% improvement in their score, versus 14.9% in the placebo group. For a 90% improvement on the same scale, the figures were 27.6% (risankizumab) versus 5.7% (placebo), and for complete (100%) improvement, 17.2% versus 1.1%. On another doctor-rated overall skin score (sPGA), 32.2% of the risankizumab group reached "clear" or "almost clear" compared with 11.5% in the placebo group. Regarding unwanted medical events, the reported data shows that during the first 16 weeks, 25 participants in the risankizumab group and 20 in the placebo group experienced at least one treatment-emergent adverse event (that is, any medical event that began or got worse after starting the study drug). Five participants in the risankizumab group experienced a serious adverse event during this period, compared with none in the placebo group. In the later open-label phase, 40 participants who had originally received risankizumab and 29 who had originally received placebo reported at least one such event, with 5 serious events recorded in each of those groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03991936 · results posted 27 March 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 55 people in total, split evenly across five groups of 11. Each group received injections directly into affected nails (a method called intralesional injection) of either a dummy treatment (placebo) or one of four different doses of a medicine called triamcinolone acetonide — at 2.5, 5.0, 7.5, or 10 mg/mL. The trial was measuring which dose level was most effective for nail psoriasis, and also tracking changes in nail psoriasis severity and quality of life. One person in each group did not complete the study, leaving 10 completers per group. The reported data shows that, across all groups combined, the lowest concentration identified as most effective was 2.5 mg/mL. For nail severity — measured using a scoring tool called the NAPSI, where a score of 0 means no psoriasis and 8 means the worst — the reported changes from the start of the trial were: the placebo group's score dropped by about 0.96 points; the 2.5 mg/mL group dropped by about 3.96 points; the 5.0 mg/mL group by about 2.96 points; the 7.5 mg/mL group by about 3.53 points; and the 10 mg/mL group by about 3.93 points. For quality of life (measured as a percentage, where 0% means no impact and 100% means the worst impact), the reported data shows an average change of 4.5 percentage points across all groups combined — however, a breakdown by individual group was not reported in the data. Regarding reported side effects linked to the study treatment, the data shows 0 participants in the placebo group experienced a related adverse event, compared with 3 in the 2.5 mg/mL group, 4 in the 5.0 mg/mL group, 7 in the 7.5 mg/mL group, and 8 in the 10 mg/mL group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT05020249 · results posted 22 March 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT05020249) enrolled 47 people with psoriasis — 15 received a placebo (an inactive treatment) and 32 received bimekizumab 320 mg given every four weeks. The trial was primarily measuring two things at the 16-week mark: how many participants had at least a 90% improvement in a skin-scoring system called PASI (which rates the redness, thickness, scaliness, and area of psoriasis patches on a scale of 0 to 72), and how many were rated "clear" or "almost clear" by a doctor using a separate 0–4 scale called the IGA. The reported data shows that for the two primary measures at week 16, 0% of participants in the placebo group met either target, compared with 81.3% in the bimekizumab group for the 90%-improvement skin score (PASI90), and 87.5% for the doctor's "clear or almost clear" rating (IGA 0/1). For the secondary measures — also reported at week 16 unless noted — the reported data shows that 21.9% of the bimekizumab group achieved a complete 100% improvement in the skin score (PASI100), and 21.9% were rated fully "clear" by the doctor (IGA 0), compared with 0% in both cases for placebo. At the earlier four-week check, 75.0% of the bimekizumab group had reached at least a 75% improvement in the skin score (PASI75), versus 0% on placebo. Finally, when participants rated their own itch on a 0–10 daily diary, 57.7% of the bimekizumab group reported a reduction of at least 4 points by week 16, compared with 0% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04493424 · results posted 20 March 2024
According to the results reported on ClinicalTrials.gov, this extension trial (NCT04493424) enrolled 108 participants who had previously taken part in a parent trial of spesolimab (also known as BI 655130), a medicine being studied for palmoplantar pustulosis — a skin condition that causes painful blisters and redness on the palms of the hands and soles of the feet. The trial's main focus was on tracking unwanted or unexpected health events (called treatment-emergent adverse events) that occurred while participants were receiving the study medicine. Secondary measurements looked at changes in skin severity scores over time, up to weeks 48 and 96 of the overall study period. The reported data shows that none of the 108 participants were recorded as having formally "completed" the trial under the study's own definitions, though this may reflect how the trial's milestones were structured rather than participants dropping out. The reported data shows that 96 out of 108 participants experienced at least one treatment-emergent adverse event during the study. Regarding the skin severity scores, the PPP ASI (a scale from 0 meaning clear skin to 72 meaning the worst possible condition), the reported average percentage change from the starting score in the parent trial was approximately a 76.9% reduction at week 48 and a 77.6% reduction at week 96. For the proportion of participants whose PPP ASI score dropped by at least 50% from their original starting point, the reported figures were 0.770 (about 77 in every 100 participants) at week 48 and 0.683 (about 68 in every 100) at week 96. A separate measure asked doctors to rate each participant's skin globally; the reported data shows that 0.720 (about 72 in every 100) participants had a doctor's rating of "clear" or "almost clear" at week 48, and 0.707 (about 71 in every 100) at week 96. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04305327 · results posted 28 February 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04305327) enrolled a total of 12 participants across four groups: 2 received brodalumab, 6 received ustekinumab, 2 received a placebo followed by brodalumab, and 2 received a placebo followed by ustekinumab. The trial was studying treatments for psoriasis in children and was measuring things like the severity and extent of skin plaques, a doctor's overall rating of the skin condition, and the impact of the skin condition on the child's quality of life — all assessed at 12 weeks. The reported data shows that none of the 12 participants completed the study — all 12 are listed as "not completed." Because of this, the results for the primary outcome — which measured how many participants had at least a 75% improvement in their psoriasis skin score (called a PASI 75 response) at 12 weeks — were recorded as "not available" (meaning no usable result was reported). The reported data shows the same "not available" result for other skin score measures, including 90% and 100% improvement in the psoriasis score. For all of the secondary outcomes, including the doctor's global skin rating and the children's quality-of-life score, no numerical results were reported in the data submitted to ClinicalTrials.gov. In summary, because no participants completed the trial, no outcome data was able to be reported for any of the measures this study set out to assess. The reasons for non-completion are not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03718884 · results posted 29 January 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03718884) involved 29 adult participants. The study was looking at how a medicine called mirikizumab affects the way the body processes five other common drugs — midazolam, warfarin, dextromethorphan, omeprazole, and caffeine. The trial ran in two back-to-back periods: in the first period (6 days), all 29 participants received the cocktail of five drugs on their own; in the second period (120 days), the same participants received mirikizumab alongside the drug cocktail. Three participants did not complete the second period. The measurements taken are called "pharmacokinetics" — a term that simply means tracking how much of a drug gets into the bloodstream and how long it stays there. The reported data shows the peak blood-level concentrations (the highest amount of each drug detected in the blood) and, for midazolam, the total exposure over time. For midazolam, the reported peak level was 4.07 nanograms per millilitre (ng/mL) without mirikizumab and 4.46 ng/mL with it. For warfarin, the figures were 543 ng/mL and 506 ng/mL respectively. For dextromethorphan, 1.60 ng/mL and 1.47 ng/mL. For omeprazole, 369 ng/mL and 437 ng/mL. For caffeine, 2,400 ng/mL and 2,340 ng/mL. The total blood exposure to midazolam over time was reported as 13.4 nanogram-hours per millilitre without mirikizumab and 15.6 with it. The reported data shows relatively small numerical differences between the two periods across all five drugs, though what those differences mean clinically is not described in the submitted results. It is also worth noting that several secondary outcome measures were listed in the data but their results were not reported, so those figures are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04533737 · results posted 9 January 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04533737) enrolled 113 people with psoriasis — 56 in one group and 57 in another. Participants were randomly assigned to receive either brodalumab (plus a dummy/placebo version of the other medicine) or guselkumab (plus a dummy/placebo version of the other medicine). The main thing the trial was measuring was the proportion of participants whose psoriasis skin score — assessed using a standard tool called the PASI, which rates redness, thickness, and scaliness across the body on a scale of 0 to 72 — reached a full 100% improvement from their starting score by week 16. Around 50 people in each group completed the full study period. The reported data shows that at week 16, an estimated 53.4% of participants in the brodalumab group and 35.9% in the guselkumab group had reached that full 100% improvement in their skin score. Looking at earlier and later time points, the reported data shows that by week 4, roughly 23% of the brodalumab group and about 2% of the guselkumab group had reached that same full clearance mark; by week 8 those figures were about 41% and 17% respectively; and by week 28 they were approximately 61% and 37%. For a 90% improvement in skin score (a slightly lower bar), the reported figures at week 16 were approximately 69% for brodalumab and 45% for guselkumab. The trial also measured how many participants had completely clear skin according to a separate five-point doctor's rating scale (scored 0 = clear to 4 = severe): at week 16, approximately 56% of the brodalumab group and 36% of the guselkumab group were rated as completely clear, rising to about 62% and 41% respectively by week 28. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04607980 · results posted 15 December 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04607980) involved 563 adults with psoriasis — a skin condition that causes red, scaly patches. Participants were split into two groups: 281 received ABP 654 (the medicine being tested) and 282 received ustekinumab (an already-approved medicine used for comparison). The trial measured changes in skin symptoms using a scoring system called PASI, which rates the redness, thickness, and scaliness of psoriasis patches on a scale from 0 (clear skin) to 72 (most severe). A lower PASI score over time indicates fewer or less severe skin patches. At the 28-week point, participants were re-assigned to continue on one or both medicines for the remainder of the study. The reported data shows that by Week 12, both groups had a very similar average reduction in their PASI score — around 82% improvement from where they started (81.92% for the ABP 654 group and 81.91% for the ustekinumab group). For secondary measures, the reported data shows that by Week 12, roughly 70% of participants in both groups had achieved at least a 75% improvement in their skin score (a benchmark called "PASI 75"), and around 20% in each group had completely clear skin scores by around Week 28. Looking at body surface area affected by psoriasis, both groups showed a reported average reduction of roughly 17–18 percentage points by Week 12, increasing to around 21–25 percentage points by Week 52. Results for skin clearance at later time points also appeared broadly similar across the groups, though some figures for certain sub-groups were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04655313 · results posted 15 December 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04655313) involved 20 participants who used a cream called ARQ-151 at a concentration of 0.3%. The cream contains an active ingredient called roflumilast. The trial was measuring how much of the cream's active ingredient and its breakdown product (called the N-oxide metabolite) entered participants' bloodstreams, as well as tracking any unwanted medical events or skin reactions at the site where the cream was applied. All 20 participants who started the trial completed it. The reported data shows that roflumilast was detected in the blood at two separate measurement points, with levels of 3.15 ng/mL (nanograms per millilitre, a very small unit of concentration) and 1.68 ng/mL. The breakdown product of roflumilast was also detected at two points, with levels of 28.9 ng/mL and 15.7 ng/mL. Regarding unwanted medical events, the reported data shows that 4 out of 20 participants experienced at least one such event during the treatment period. For skin reactions at the application site, the trial tracked redness (called erythema) at multiple time points — the reported numbers across those assessments ranged from 0 to 19 participants showing varying levels of redness, though the data does not include labels explaining which number corresponds to which severity level or time point, so a full breakdown cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03279978 · results posted 21 September 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03279978) tested a investigational medicine called BI 730357 across several different doses (25 mg, 50 mg, 100 mg, 200 mg, and 400 mg), comparing it to a placebo (a dummy treatment with no active ingredient). Participants were assigned to take their dose either while fasting (on an empty stomach) or after eating a meal. In total, 83 people started the study across all groups, and 78 completed it. The trial was primarily measuring how many participants experienced side effects that investigators considered related to the study medicine, and secondarily tracking how much of the medicine entered the bloodstream and how it built up over time with repeated dosing. The reported data shows that when it came to the primary outcome — the number of people who experienced drug-related side effects — the numbers were similar across groups. In the placebo groups, 4 out of 11 (fasting) and 2 out of 9 (fed) participants had drug-related side effects recorded. Across the BI 730357 dose groups, the reported numbers ranged from 1 to 2 participants per group experiencing drug-related side effects. For the secondary outcomes, the trial tracked how much of the medicine was present in the blood. The reported data shows that higher doses were associated with higher blood levels of the medicine, and that taking the dose with food also appeared to be associated with higher blood levels compared to fasting at the same dose. For example, after the first dose, the overall exposure measure (a way of summing up drug levels over 24 hours) was reported as 3,590 units for the 50 mg fasting group, compared to 4,620 units for the 50 mg fed group. Blood levels continued to rise with increasing doses up to 400 mg, where the highest exposure figures were recorded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03418493 · results posted 21 September 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03418493) tested a drug called LY3316531 across three parts (A, B, and C). In total, 63 people started the trial across all groups. Part A compared different doses of LY3316531 — given either directly into a vein (IV) or under the skin (SC) — against a dummy treatment (placebo). Part B tested a high dose given repeatedly over time, and Part C tested a mid-range dose in a separate group of participants. The trial was primarily set up to track serious unwanted health events that investigators believed were linked to the study drug, and it also measured how the drug moved through the body (its "pharmacokinetics" — that is, how much of the drug got into the bloodstream and how quickly). The reported data shows that, for the primary outcome — serious health events considered by the investigator to be related to the study drug — zero participants out of all groups experienced such an event, with one exception: 1 out of 6 participants in the 2000 mg IV group in Part B was reported to have had such an event. For the secondary outcomes measuring how much drug reached the bloodstream, the reported peak blood levels (the highest amount of drug measured at any one point) rose with increasing doses in Part A, ranging from 1.27 micrograms per millilitre at the lowest IV dose (3 mg) up to 808 micrograms per millilitre at the highest IV dose (2000 mg). The under-the-skin (SC) 300 mg dose reached a lower peak level (27.2) than the same dose given directly into a vein (115). In Part B, the peak level after repeated high-dose treatment was reported as 876, and in Part C the mid-range dose reached a peak of 124. Similar patterns were seen in the measure of total drug exposure over time (the area under the curve), with figures ranging from 401 at the lowest dose up to 319,000 at the highest dose in Part A, and 258,000 reported for the repeat high-dose group in Part B. No area-under-the-curve data for Part C was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04207801 · results posted 14 August 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04207801) enrolled 90 people with psoriasis across three groups of 30 participants each (Arm-1, Arm-2, and Arm-3). The trial was measuring how skin scores changed over time using two standard psoriasis rating tools: the PASI (Psoriasis Area and Severity Index, scored 0–72, where higher numbers mean more severe disease) and the IGA (Investigator Global Assessment, a 0–4 scale where 0 means clear skin). By the end of the study, 26 people in Arm-1, 26 in Arm-2, and 23 in Arm-3 had completed the trial. The reported data shows that, for the main outcome — the number of participants whose PASI score dropped by 75% or more by week 12 — 18 people in Arm-1, 19 in Arm-2, and 8 in Arm-3 reached that level of score reduction. At earlier checkpoints (weeks 4 and 8), the reported numbers of people reaching that 75% score reduction were lower across all groups. For a less demanding target of a 50% reduction in PASI score, the reported data shows more participants reached that mark at week 4 (23 in Arm-1, 20 in Arm-2, 14 in Arm-3), with numbers falling at weeks 8 and 12. The reported average percentage change in PASI score from the starting point was –68.1% for Arm-1, –60.3% for Arm-2, and –43.8% for Arm-3 at week 4, with smaller reductions reported at weeks 8 and 12. For the IGA scores, the reported data shows that at week 4, 17 participants in Arm-1, 16 in Arm-2, and 8 in Arm-3 achieved an IGA score of 0 or 1 (meaning "clear" or "almost clear" on the scale), while by week 12, none in any group were reported at that level. The reported average percentage decrease in IGA score from the starting point was –50.8% for Arm-1, –46.9% for Arm-2, and –28.9% for Arm-3 at week 4, again with smaller changes at the later time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03766685 · results posted 8 August 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03766685) enrolled 172 participants across four groups, each testing a different device for self-injecting bimekizumab — a medicine delivered by injection. The four devices were: a 1 mL safety syringe, a 1 mL auto-injector (a pen-like device that delivers the injection automatically), a 2 mL safety syringe, and a 2 mL auto-injector. The main thing the trial was measuring was how many participants were able to successfully give themselves a complete injection using these devices, without any device-related problems serious enough to stop them continuing, after receiving training in how to do so. The reported data shows that, by Week 8, 100% of participants in both the 1 mL safety syringe group and the 1 mL auto-injector group met the criteria for a successful self-injection. For the 2 mL devices at Week 8, 100% of participants in the 2 mL safety syringe group and 94.7% in the 2 mL auto-injector group met those same criteria. The trial also measured these rates at the very start of the study (baseline), after initial training. At that earlier point, the reported figures were 100% for the 1 mL safety syringe, 97.1% for the 1 mL auto-injector, 100% for the 2 mL safety syringe, and 100% for the 2 mL auto-injector. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03897088 · results posted 31 May 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03897088) enrolled 231 adults — 114 in the placebo group and 117 in the tildrakizumab group. The trial was looking at a skin condition affecting the scalp, and its main goal was to measure how many participants showed a scalp assessment score of "clear" or "almost clear" (with at least a 2-point improvement from the start) after 16 weeks of treatment. The trial also tracked a range of safety-related events, including any adverse events (unwanted health occurrences), serious infections, cancers, and major heart or blood vessel events. The reported data shows that at Week 16, approximately 7.3% of participants in the placebo group and 49.4% of participants in the tildrakizumab group met the scalp assessment improvement target. Regarding adverse events more broadly, the reported data shows that around 51.8% of the placebo group and 53% of the tildrakizumab group experienced at least one adverse event of any kind during the study. Serious adverse events were reported in 3.5% of the placebo group and 2.6% of the tildrakizumab group. Severe infections (defined as infections meeting a serious adverse event definition or requiring intravenous antibiotics) were reported in 0% of participants in both groups. Cancers (excluding a specific cervical condition) were reported in 0% of the placebo group and 1.71% of the tildrakizumab group. Melanoma skin cancer was reported in 0% of participants in both groups. Major heart or blood vessel events were reported in 1.75% of the placebo group and 0.85% of the tildrakizumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03818035 · results posted 10 May 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03818035) looked at a medicine called guselkumab (100 mg) in people with psoriasis — a skin condition causing red, scaly patches. A total of 880 people entered the first phase of the trial. The study was designed in three parts: an open phase where everyone received the medicine, a double-blind phase (where neither the participants nor the medical team knew who was getting which dosing schedule) comparing different dosing intervals, and a withdrawal phase where some participants stopped treatment to see how long skin improvement lasted. The trial tracked a scoring system called PASI, which measures the severity and spread of psoriasis on a scale from 0 (no psoriasis) to 72 (most severe). The reported data shows that the main result — the proportion of participants with a very low psoriasis score (below 3 on the PASI scale) at around the 68-week mark — was 92.6% in the group receiving the medicine every 8 weeks, and 91.9% in the group receiving it every 16 weeks. Among those who then stopped treatment entirely and were followed for up to week 220 (roughly four years from the start), the reported data shows that only a small proportion maintained that low score throughout — around 7.5% of those with a shorter history of psoriasis (2 years or less) in one withdrawal group, and 0% of those with a longer history; figures in the other withdrawal group were 2.8% and 1.5% respectively. For participants who needed to restart treatment, the re-treatment phase data was also collected, though detailed outcome numbers for that group were not fully reported in the data provided. Regarding how quickly participants' skin scores improved, the reported data shows that the time to a 75% improvement in PASI score was recorded as 84 days across all subgroups examined, regardless of how long they had had psoriasis. Reaching a 90% improvement took longer for those with a longer history of psoriasis — around 106–114 days compared to 89–112 days for those with a shorter history — and reaching complete clearance (100% improvement) ranged from 141 days in the shorter-history group to 416 days in the longer-history group, according to the reported figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02340169 · results posted 28 March 2023
According to the results reported on ClinicalTrials.gov, this trial involved 129 children and teenagers using a topical skin spray called Topicort® (desoximetasone 0.25%). Participants were split into three age groups: 84 young people aged 12–17, 35 aged 6–11, and 10 aged 2–5. The trial was primarily measuring whether the spray affected a hormone system in the body called the HPA (hypothalamic-pituitary-adrenal) axis — essentially, whether using the spray on the skin had any impact on the body's ability to produce a stress hormone called cortisol, which was checked with a stimulation test. A total of 106 participants completed the study, while 23 did not finish. The reported data shows that, when looking at the primary measure — signs of possible HPA axis effect based on cortisol test results — 21 out of the participants in the 12–17 age group, 13 in the 6–11 age group, and 2 in the 2–5 age group met the criteria that indicated a potential concern with their cortisol response. For the secondary outcomes, the reported data shows that 1 participant across the whole group experienced an adverse event (an unwanted or unexpected health occurrence). The trial also measured drug concentration levels in the blood before dosing; the reported figures were approximately 528 pg/mL (a very small unit of measurement) for the older age group (12–17) and approximately 475 pg/mL for the 6–11 age group. No blood concentration data was reported for the youngest group (2–5 years). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03556202 · results posted 21 March 2023
According to the results reported on ClinicalTrials.gov, this trial involved three groups of participants who received different doses or sequences of study medications for psoriasis (a skin condition causing red, scaly patches). The groups were: 527 people receiving 125 mg of mirikizumab every 8 weeks, 1,020 people receiving 250 mg of mirikizumab every 8 weeks, and 389 people who had previously received a different medicine (secukinumab) before switching to 250 mg of mirikizumab every 8 weeks. The trial measured how participants' skin cleared over time, using standardised scoring tools that doctors and patients used to rate the severity of psoriasis symptoms and their impact on daily life. The reported data shows the following figures at the 104-week (roughly two-year) mark. For the two main measures: among participants who had already achieved near-clear skin entering this phase, 46.7%, 55.7%, and 38.9% (across the three groups respectively) still met that standard by week 104 on the physician's rating scale; and 49.3%, 56.8%, and 39.4% maintained a 90% or greater reduction in their skin-severity score. For additional measures, 30.4%, 36.4%, and 22.6% of participants across the three groups had a complete (100%) reduction in their skin-severity score. Regarding self-reported symptoms such as itch, pain, stinging, and burning, 31.1%, 33.6%, and 23.4% reported being free of all four symptoms. On a quality-of-life questionnaire, 41.5%, 47.3%, and 34.5% achieved a score reflecting little to no impact on daily life. For the smaller group of participants with psoriasis on their palms and soles, the reported average change in that specific score was −6.55, −6.80, and −7.38 points across the three groups (lower scores indicate less severe disease on a scale of 0 to 72). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04102007 · results posted 21 March 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 244 participants, all of whom received the treatment being studied — a medicine called risankizumab. The trial was measuring how people with psoriasis responded to this treatment, looking mainly at how a doctor rated the appearance of their skin, and also at how participants themselves felt about their symptoms and daily life. Of the 244 people who started, 205 completed the study, and 39 did not complete it. The primary outcome used a skin scoring tool called the sPGA (Static Physician Global Assessment), where a doctor rates psoriasis on a scale from 0 (completely clear) to 4 (severe). The main result being tracked was how many participants reached a score of 0 or 1 — meaning their skin was rated as clear or almost clear. The reported data shows that 140 participants achieved this result at the primary time point. The reported data also shows a number of secondary measurements: at a later time point, 152 participants were recorded as reaching a sPGA score of 0 or 1, and 66 participants reached a score of 0 (completely clear skin), compared with 50 participants at the earlier time point. Additionally, 98 participants reported a score of 0 or 1 on a quality-of-life questionnaire (where lower scores indicate less impact on daily life), and 51 participants reported a score of 0 on a symptom scale measuring pain, redness, itching, and burning — meaning no symptoms at all. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04343586 · results posted 17 March 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04343586) enrolled 11 adults with Grover's Disease into a single treatment arm receiving blue light therapy. Ten participants completed the study, while one did not finish. The trial was measuring two things: the number of skin lesions (spots or sores on the skin) before and after treatment, and participants' quality of life using a standard questionnaire called the Dermatology Life Quality Index (DLQI), which asks 10 questions about how a skin condition affects daily life — scored from 0 (no impact) to 30 (severe impact). The reported data shows that the average lesion count was recorded as 27 at one point and 6 at another point during the study. For the quality-of-life questionnaire, the reported data shows an average score of 4.3 at one time point and 2.3 at another. It is worth noting that the results submission does not clearly label which measurements were taken before treatment and which were taken after, so the exact timing of each number cannot be confirmed from the data as reported. It should also be noted that this was a small, preliminary study with just 11 participants and no comparison group (for example, a group receiving no treatment or a different treatment), which the trial itself described as aimed at gathering early findings. No safety or side-effect data was included in the structured results submitted to ClinicalTrials.gov, so that information was not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03442088 · results posted 20 January 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03442088) enrolled 28 people with psoriasis who had a specific blood cell pattern called the "AM-endotype" — meaning their blood showed unusually high levels of certain immune cells called monocytes. The trial was testing the drug apremilast and measuring whether it changed those abnormal monocyte levels, as well as several other substances in the blood linked to inflammation. Of the 28 participants who started, 23 completed the trial and 5 did not. The reported data shows that for the primary outcome — the percentage change in each participant's abnormal monocyte marker from the start of the trial to 16 weeks — two summary figures were reported: 0.5665% and 0.1715% (these appear to represent summary statistics such as a median and another measure of the data, though the labels for which is which were not specified in the submitted data). For the secondary outcomes, the reported blood levels before and after treatment were: a protein called myeloperoxidase measured at 24,198 and 24,294 pg/mL (a unit of concentration); TNF alpha at 14.95 and 14.26 pg/mL; IL-17 at 1.513 and −0.831 pg/mL; and tissue factor at 72.28 and 75.52 pg/mL. The data for an additional planned outcome measuring other monocyte and neutrophil markers was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03611751 · results posted 20 December 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03611751) enrolled a total of 1,020 adults with psoriasis across three groups: 511 received BMS-986165 (an investigational tablet), 255 received a placebo (a dummy treatment with no active ingredient), and 254 received apremilast (an existing approved treatment used as a comparator). The trial measured how participants' skin responded over time, with the main focus on results at 16 weeks. Researchers tracked two key things: how many participants reached a near-clear or clear skin rating on a doctor's scale (called sPGA), and how many achieved at least a 75% improvement on a standardised skin severity scoring system (called PASI, which rates redness, thickness, and scaling across the body on a 0–72 scale). The reported data shows that at 16 weeks, 253 out of 510 participants in the BMS-986165 group reached a near-clear or clear skin rating (sPGA score of 0 or 1), compared with 22 out of 254 in the placebo group. For the 75% skin improvement measure (PASI 75), 271 participants in the BMS-986165 group reached this threshold, compared with 24 in the placebo group. For secondary measures at 16 weeks, the reported data shows that 138 BMS-986165 participants achieved a 90% skin improvement (PASI 90) versus 7 on placebo and 46 on apremilast; 52 versus 3 versus 11 participants achieved a 100% improvement (PASI 100); and 80 versus 3 versus 16 participants were rated as completely clear (sPGA 0). On a participant-reported symptom diary scored from 0 to 100 (where lower is better), the average score change from the start of the trial was reported as −28.9 points for BMS-986165, −4.2 points for placebo, and −21.5 points for apremilast. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04603027 · results posted 19 December 2022
According to the results reported on ClinicalTrials.gov, this trial tested a treatment called EDP1815 across three different dosing groups (called Cohort 1, 2, and 3) in people with psoriasis. Each cohort included both participants who received the active treatment and those who received a placebo (a dummy pill with no active ingredient). In total, 249 people started the trial — 166 in the active treatment groups and 83 in the placebo groups. The main thing being measured was a psoriasis scoring system called PASI (Psoriasis Area and Severity Index), which runs from 0 (no disease) to 72 (the most severe possible). A lower score or a reduction in score means less psoriasis on the skin, as assessed by a doctor. The reported data shows that by week 16, the average PASI score had fallen by around 14% in the combined placebo group, compared to roughly 20%, 23%, and 23% in the three active treatment cohorts respectively. Looking at earlier time points (weeks 4, 8, and 12 averaged together), the reported reductions were around 19% for placebo and 22%, 23%, and 19% for the three active cohorts. In terms of actual point changes on the 0–72 scale, the placebo group dropped by an average of about 1.2 points, while the active cohorts dropped by roughly 1.9 to 2.0 points. The number of participants who achieved at least a 50% reduction in their PASI score at any measured point was 8 in the placebo group, and 11, 15, and 10 across the three active cohorts. For a 75% reduction — a higher bar — 2 participants in both the placebo group and Cohort 1 reached this, while 4 each did so in Cohorts 2 and 3. Time to first reaching the 50% reduction milestone was not reported for Cohorts 1 and 2 active groups; for the placebo group it was 160 days, and for Cohort 3 active it was 146 days. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04211363 · results posted 3 November 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04211363) enrolled 439 people in total — 286 were assigned to use a cream containing the active ingredient roflumilast (0.3%), and 153 used a plain "vehicle" cream with no active ingredient (sometimes called a placebo). Of those who started, 255 in the active cream group and 133 in the vehicle group completed the trial. The trial was measuring changes in plaque psoriasis over 8 weeks, using standardised rating scales that doctors used to score the severity of participants' skin condition. The reported data shows that for the main outcome — the number of people whose skin was rated "clear" or "almost clear" and had improved by at least two steps on the severity scale by Week 8 — 108 participants in the roflumilast cream group met this measure, compared with 8 in the vehicle cream group. For the secondary outcomes, the reported data shows that the number of days until participants reached a 50% reduction in their psoriasis severity score was 31 days in the roflumilast group and 104 days in the vehicle group. At Week 8, 106 participants in the roflumilast group showed a 75% reduction in their psoriasis severity score, versus 10 in the vehicle group; 57 versus 3 showed a 90% reduction. For psoriasis in skin folds (such as the groin or underarms), 37 participants in the roflumilast group versus 4 in the vehicle group reached the "clear" or "almost clear" threshold, and 33 versus 3 were rated fully "clear" in those areas. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04167462 · results posted 2 November 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04167462) enrolled 220 adults with psoriasis — 146 in the group receiving BMS-986165 (an investigational tablet) and 74 in the group receiving a placebo (a dummy tablet with no active ingredient). The trial was measuring how participants' psoriasis changed after 16 weeks, using two main scoring tools: a doctor's assessment of overall skin severity (called the sPGA, rated from 0 "clear" to 4 "severe"), and a more detailed skin scoring system called the PASI, which rates redness, thickness, and scaliness across different body areas on a scale from 0 to 72. The trial was comparing how many people in each group reached certain improvement targets by week 16. The reported data shows that for the two primary (main) measures, 55.6% of participants taking BMS-986165 had their doctor rate their skin as "clear" or "almost clear" (sPGA score of 0 or 1) with meaningful improvement from their starting point, compared with 6.8% in the placebo group. Separately, 68.8% of those taking BMS-986165 had their PASI skin score improve by at least 75% from the start, compared with 8.1% in the placebo group. For the secondary (additional) measures, 38.2% of the BMS-986165 group showed at least a 90% improvement in their PASI score versus 1.4% in the placebo group, and 4.2% versus 0% achieved a full 100% improvement. Regarding symptoms participants reported themselves — such as itch, pain, burning, and skin tightness — the BMS-986165 group reported an average decrease of 29.4 points on a 0–100 scale, compared with a decrease of 1.8 points in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03536884 · results posted 10 October 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03536884) studied two medicines — bimekizumab (BKZ) and secukinumab — in adults with moderate-to-severe plaque psoriasis (a skin condition causing red, scaly patches). The trial ran across several phases over a number of years, with the main early phase involving 373 people receiving bimekizumab and 370 receiving secukinumab. Participants were later reassigned to different dosing schedules across maintenance and longer-term follow-up periods, with hundreds of people continuing into those later stages. The trial measured changes in skin appearance using two main scoring tools: the PASI (Psoriasis Area and Severity Index, a 0–72 scale where higher numbers mean more severe disease) and the IGA (Investigator's Global Assessment, a 0–4 scale of overall severity). The reported data shows that, for the main 16-week result — the trial's primary measure — 61.7% of participants in the bimekizumab group achieved a complete skin clearance score (PASI100, meaning a 100% improvement from their starting score), compared with 48.9% in the secukinumab group. For secondary measures at week 16, the reported data shows that 85.5% of the bimekizumab group and 74.3% of the secukinumab group achieved at least a 90% improvement in their PASI score (PASI90); and 85.5% versus 78.6% respectively were rated as "clear" or "almost clear" by investigators (IGA score of 0 or 1). At the earlier four-week mark, 71.0% of the bimekizumab group and 47.3% of the secukinumab group had reached at least a 75% improvement in their PASI score. At week 48, complete skin clearance (PASI100) was reported in 67.3% of those who had received bimekizumab across both early and maintenance phases, compared with 46.2% of those who had received secukinumab across the same timeframe. The trial also tracked unwanted events (side effects and other medical occurrences) throughout the study, reported as the number of new events per 100 years of participation. The reported data shows these rates varied across the different treatment periods and dosing schedules, ranging from approximately 74 to 331 events per 100 participant-years depending on the group and phase — with rates generally appearing lower in the later, longer-term follow-up periods than in the earlier phases. The reported data does not allow conclusions to be drawn about the nature or seriousness of individual events from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04128007 · results posted 30 September 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04128007) enrolled 304 people with plaque psoriasis affecting the scalp — 200 in the roflumilast foam 0.3% group and 104 in the vehicle foam (a foam containing no active ingredient, used for comparison) group. Of those, 177 and 87 participants respectively completed the study. The trial ran for 8 weeks and measured how participants' scalp psoriasis responded, using several standardised rating scales scored by both clinicians and the participants themselves. The reported data shows that, on the main measure — a clinician-rated scalp assessment called the S-IGA — 107 out of 200 participants in the roflumilast group reached the target score of "clear" or "almost clear" (with at least a 2-grade improvement from the start), compared with 10 out of 104 in the vehicle group. On a similar body-wide assessment at week 8, 73 roflumilast participants and 6 vehicle participants reached that same threshold. For scalp itch (rated by participants on a 0–10 scale), the numbers achieving a meaningful reduction of 4 or more points were reported as 74 vs 14 at week 2, 98 vs 19 at week 4, and 110 vs 15 at week 8. On a broader symptom diary (scored 0–160, where lower is better), average scores dropped by 45.0 points (roflumilast) vs 25.4 points (vehicle) at week 4, and by 55.0 vs 27.5 points at week 8. The reported data also shows that the roflumilast group reached a 50% reduction in a detailed scalp severity score in a median of 28 days; a comparable figure for the vehicle group was not reported. Finally, 121 roflumilast participants and 19 vehicle participants achieved a 75% reduction in that same scalp severity score. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
-
NCT04664153 · results posted 26 August 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04664153) tested a topical (applied to the skin) treatment called PF-07038124 0.01% ointment against a vehicle (a plain ointment with no active ingredient, similar to a placebo) in two separate groups of people: those with atopic dermatitis (eczema) and those with plaque psoriasis. A total of 104 people started the trial — 34 received the vehicle and 36 received the active ointment for eczema, while 17 received the vehicle and 17 received the active ointment for psoriasis. All treatments were applied once daily. The trial measured changes in standard skin scoring tools over 6 weeks — a higher score on these tools means more severe disease, and a lower score means less severe disease. The reported data shows that for the eczema group, participants using the vehicle ointment had an average reduction of 35.5% in their eczema severity score (called EASI) from the start of the trial to week 6, while those using PF-07038124 had an average reduction of 74.9%. For psoriasis, the vehicle group's severity score (called PASI) changed by +0.1 points (essentially no change) from the start of the trial to week 6, while the PF-07038124 group's score reduced by 4.8 points. Among the secondary measurements reported for eczema, 44.4% of participants using PF-07038124 reached a score of "clear" or "almost clear" on a separate 5-point doctor's rating scale at week 6, compared with 8.8% in the vehicle group. By week 6, 61.1% of those using PF-07038124 had achieved at least a 75% improvement in their eczema severity score, compared with 20.6% in the vehicle group. The reported data also shows that for the self-reported itch score (rated from 0 to 10), 41.2% of PF-07038124 eczema participants reported a meaningful reduction in itch (defined as a drop of 4 or more points) by weeks 4 and 6, compared with 6.9% and 13.8% respectively in the vehicle group at those same time points. These figures describe only what was measured and recorded in this trial, and no conclusions about broader use should be drawn from them alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04015518 · results posted 28 July 2022
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called spesolimab as a treatment for palmoplantar pustulosis (PPP) — a skin condition that causes painful blisters and pustules on the palms of the hands and soles of the feet. A total of 152 people took part, divided into five groups: one group received a placebo (a dummy treatment with no active medicine), and four groups received different doses of spesolimab. The trial's main goal was to measure how much a scoring system called the PPP ASI — which rates the severity of the skin condition on a scale from 0 (no disease) to 72 (worst possible) — changed from the start of the trial to week 16. The reported data shows that all five groups, including the placebo group, had lower PPP ASI scores at week 16 compared to where they started. The placebo group's score decreased by about 33.6%, while the four spesolimab dose groups saw decreases of approximately 44.2%, 48.3%, 46.2%, and 38.9% respectively. For pain (measured on a scale of 0 to 10, where 0 means no pain and 10 means very severe pain), the reported data shows all groups also had lower pain scores at both week 4 and week 16 compared to baseline. Regarding the number of people whose PPP ASI score dropped by at least 50% by week 16, the reported data shows this occurred in 12 participants in the placebo group, compared to 7, 10, 12, and 18 participants across the four spesolimab dose groups. For a 75% drop in score, the numbers were 3 in the placebo group and 3, 6, 4, and 9 across the spesolimab groups. It is also worth noting that not everyone completed the trial — for example, 11 out of 43 people in the placebo group and 12 out of 44 in the highest-dose spesolimab group did not finish the study, though the reasons were not detailed in the reported data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03850483 · results posted 29 June 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03850483) tested a topical (applied to the skin) cream called PF-06700841 in people with psoriasis. The trial ran in two stages. In Stage 1, around 294 people were assigned to receive either the active cream at various strengths (0.1%, 0.3%, 1.0%, or 3.0%) or a plain "vehicle" cream containing no active ingredient, applied either once or twice daily for 12 weeks. In Stage 2, a further 50 people were assigned to either the 3.0% twice-daily cream or the vehicle cream. The trial was primarily measuring changes in a standard psoriasis severity score called the PASI (which runs from 0 to 72, where higher numbers mean more severe disease). The reported data shows that, for the main outcome — change in PASI score from the start of the trial to week 12 — all groups showed some reduction in their scores. The vehicle (no active ingredient) groups showed average reductions of around 1.6 to 2.2 points. Among the active cream groups, the reported reductions ranged from approximately 1.4 points (0.3% once daily) up to about 3.0 points (1.0% twice daily), with the 3.0% twice-daily group showing a reduction of about 2.8 points. For one of the secondary outcomes, the trial tracked what percentage of participants reached a doctor-rated score of "clear" or "almost clear" skin by week 12 with at least a 2-point improvement. The reported data shows this ranged from about 6.9% in the once-daily vehicle group up to about 27.6% in the 1.0% twice-daily active cream group. The reported data for some other secondary time points across weeks 1–16 was only partially available in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03179605 · results posted 1 June 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 22 people who used a cream called DFD-06, which contains a medicine called clobetasol propionate (a type of steroid used on the skin). Twenty-one participants completed the trial. The trial was looking at three main things: whether the cream affected a part of the body's hormone system called the HPA axis (which helps control the body's stress response), how participants' skin condition changed over time as rated by a clinician, and how much of the cream's active ingredient entered the bloodstream. The reported data shows that 3 out of the participants had a result suggesting their HPA axis — the hormone system mentioned above — was affected at Day 15, based on a test that measures how the body responds to a hormone signal. Regarding skin condition, the reported data shows that across several time points during the study, the numbers of participants whose clinician-rated skin score improved by at least one step were reported as 15, 2, 8, 10, and 2 participants respectively (each figure corresponding to a different assessment point, though the specific time points for each number were not detailed in the submitted data). For the amount of the cream's active ingredient found in the blood, the reported figures across different time points were approximately 51.5, 40.4, 64.3, 42.1, and 45.5 picograms per millilitre (a picogram is an extremely tiny unit of measurement). The reported data shows results from a relatively small group of 22 people, and no comparison group (such as a placebo or different treatment) was included in this trial's reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03633396 · results posted 31 May 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03633396) looked at a condition called palmoplantar pustulosis — a skin condition that causes pustules (pus-filled spots), redness, and scaling on the palms and soles of the feet. A total of 59 people took part: 29 received a placebo (a dummy treatment with no active ingredient) and 30 received imsidolimab, an investigational medicine. The main things being measured were changes in skin severity using a scoring system called the PPPASI (where higher scores mean more severe disease, and a drop in score suggests improvement), as well as how many participants experienced unwanted health events during the study. The reported data shows that, on the primary skin severity measure, both groups had a similar average drop in their PPPASI score from the start of the study to the end — a reduction of 6.0 points in the placebo group and 6.1 points in the imsidolimab group. On a secondary measure, 50% of placebo participants and 45.8% of imsidolimab participants had their PPPASI score cut by at least half. Another secondary measure looked at how many participants were rated "clear" or "almost clear" by their doctor at week 16: 12.5% of the placebo group and 20.8% of the imsidolimab group reached that rating. Regarding unwanted health events, 20 people in the placebo group and 21 in the imsidolimab group reported at least one treatment-emergent adverse event (that is, a health problem that started or worsened after the first dose). Serious adverse events were reported in 3 placebo participants and 6 imsidolimab participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02173301 · results posted 12 April 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 200 people with psoriasis across four groups: 49 received XP23829 at 400 mg once daily, 55 received 800 mg once daily, 48 received 400 mg twice daily, and 48 received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring changes in a psoriasis scoring system called the PASI — a scale from 0 to 72 that rates the redness, thickness, and scaliness of skin lesions across the body, where a lower score means less severe disease. Not everyone finished the study: roughly 122 out of 200 participants completed it across all four groups. The reported data shows that, on average, each treatment group's PASI score decreased (improved) from the start of the study. The group taking 400 mg once daily showed an average decrease of about 38%, the 800 mg once daily group showed about 48%, and the 400 mg twice daily group showed about 51%. The placebo group showed an average decrease of about 25%. For the secondary measures, the trial also tracked how many participants reached a 75% or greater reduction in their PASI score, and how many were rated by a doctor as "clear" or "almost clear" of psoriasis. The reported data shows these numbers were very small across all groups — in most cases, only zero to five participants in any group reached these thresholds at the time points measured. These figures are descriptions of group-level averages and counts as submitted by the trial sponsor, and individual results within each group varied. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03230292 · results posted 31 March 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 43 people in total, all of whom received the study drug bimekizumab. Thirty-seven participants completed the study, while six did not. The trial was measuring how often unwanted medical events (called "treatment-emergent adverse events," or TEAEs — meaning any health issue that appeared after starting the study drug) occurred, how much of the drug was present in participants' blood over time, whether participants developed antibodies against the drug, and how participants' psoriasis skin scores changed during the study. The reported data shows that the primary measure — the rate of new unwanted medical events while on the study drug — was recorded as 76 new events per 100 patient-years (a way of accounting for the fact that different participants were in the study for different amounts of time). For the skin score measures, the PASI score rates how severe and widespread psoriasis is on a scale of 0–72, with higher numbers meaning more severe disease. The reported data shows that across multiple time points during the study, between approximately 88% and 98% of participants showed at least a 50% improvement in their PASI score compared to their starting score, and between approximately 86% and 95% showed at least a 75% improvement. Regarding antibodies to the drug, 2.3% of participants had detectable antibodies before starting treatment, rising to 25.6% overall after treatment. Blood levels of bimekizumab at various time points during the study ranged from around 5.3 to 9.3 micrograms per millilitre, dropping to around 0.31 micrograms per millilitre at the end of the follow-up period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04115839 · results posted 18 March 2022
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called filgotinib in people with psoriatic arthritis (a condition involving joint inflammation linked to psoriasis). The trial had two phases. In the main study (up to 16 weeks), 106 people took part — 36 received filgotinib 200 mg, 34 received filgotinib 100 mg, and 36 received a placebo (a dummy treatment with no active ingredient). Those who completed the main study could continue into a longer follow-up phase lasting until week 63, where participants either stayed on their filgotinib dose or, if they had been on placebo, switched to one of the two filgotinib doses. The trial was measuring things like joint tenderness and swelling, pain levels, physical function, and overall disease activity. The reported data shows that for the main outcome — the proportion of people whose joint symptoms improved by at least 20% by week 12 (a standard measure called ACR20) — 60% of those on filgotinib 200 mg, 35.3% of those on filgotinib 100 mg, and 33.1% of those on placebo met this target. For a broader disease activity score (PASDAS, rated 0–10, where lower is better), the reported average change from the starting score by week 16 was −2.1 for filgotinib 200 mg, −1.4 for filgotinib 100 mg, and −0.9 for placebo — with a negative number meaning a reduction in disease activity score. Regarding the proportion of people reaching a "minimal disease activity" state (a combined measure of joint counts, pain, function and skin scores) by week 16, the reported figures were 34.4% for filgotinib 200 mg, 24.2% for filgotinib 100 mg, and 12.1% for placebo. For "very low disease activity" (a stricter version of the same measure) at week 16, the reported figures were 3.1%, 6.1%, and 3.0% respectively — noting these were very small numbers of participants in each group. In the longer follow-up phase (reported at weeks 20 through 48), the reported data shows the numbers of participants were considerably smaller, and completion data was not reported for this phase. The PASDAS score change from the original starting point at week 48 was reported as −3.3 for those who stayed on filgotinib 200 mg, −2.0 for those who stayed on filgotinib 100 mg, −1.7 for those who switched from placebo to filgotinib 200 mg, and 0.0 for those who switched from placebo to filgotinib 100 mg — though these latter figures come from very small groups and should be interpreted with caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03412747 · results posted 2 March 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 478 adults with psoriasis across three groups: one group received bimekizumab every four weeks and then switched to every four or eight weeks (161 people), a second group received bimekizumab every four weeks throughout (158 people), and a third group received adalimumab (159 people). The trial was measuring changes in psoriasis severity using two main scoring tools — a detailed skin assessment called the PASI score (which rates redness, thickness, and scaling across the body on a scale of 0 to 72), and a doctor's overall rating called the IGA (rated 0 to 4, from clear to severe). The trial ran for 56 weeks in total. The reported data shows that at week 16, when the two bimekizumab groups were combined for comparison against adalimumab, 86.2% of bimekizumab participants had at least a 90% improvement in their PASI score, compared with 47.2% in the adalimumab group. For the doctor's overall rating at week 16, 85.3% of bimekizumab participants were rated as "clear" or "almost clear" compared with 57.2% in the adalimumab group. At week 4, 76.5% of the bimekizumab group had at least a 75% improvement in their PASI score versus 31.4% for adalimumab, and by week 16, 60.8% of bimekizumab participants had a complete 100% improvement in their PASI score compared with 23.9% for adalimumab. The reported data also shows that at week 24, results were similar across both bimekizumab dosing schedules — roughly 85–86% of participants in each bimekizumab group had at least a 90% PASI improvement, and around 86–87% were rated "clear" by their doctor, compared with approximately 52% and 58% respectively in the adalimumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00617994 · results posted 8 February 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people in total, divided equally into five groups (called Cohorts A through E) of 5 participants each. All 25 people completed the trial. The study was looking at a topical (applied to the skin) treatment called INCB018424, and was measuring three main things: how many participants experienced new or worsening side effects after starting treatment, how much of the medicine passed through the skin (called "skin flux"), and how much of the medicine was absorbed into the body (called "bioavailability" — meaning the proportion that actually enters the bloodstream). The trial also looked at changes in the appearance of psoriatic skin lesions over time. The reported data shows that the number of participants who experienced new or worsening side effects ranged from 1 to 4 across the five groups. For skin flux — the rate at which the medicine passed through the skin — the reported figures ranged from 60 to 180 nanograms per square centimetre per hour across the groups. For bioavailability, the reported data shows that between approximately 3.4% and 5.2% of the medicine was estimated to be absorbed into the bloodstream across the five groups. On the secondary measures, changes in lesion severity scores (rated on a scale of 0 to 12, where higher means more severe) and lesion area were reported for both the treated lesions and untreated "control" lesions on the same participants, though the reported data includes some inconsistencies that make a straightforward summary difficult. A doctor's overall rating of psoriasis severity was also recorded at various time points, with baseline scores across groups generally sitting around 4.0 to 4.4 on a 1–7 scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01490450 · results posted 5 November 2021
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called clazakizumab (tested at three different doses — 25mg, 100mg, and 200mg) compared with a placebo (a dummy treatment with no active ingredient) in people with psoriatic arthritis. A total of 165 people were enrolled across the four groups, with roughly 41 people in each group at the start. The trial was measuring things like joint tenderness and swelling, skin involvement from psoriasis, physical functioning, and quality of life. The reported data shows that for the main measure — the proportion of people whose joint symptoms improved by at least 20% (a standard arthritis scoring method) at week 16 — 29.3% of the placebo group reached this threshold, compared with 46.3% in the 25mg group, 52.4% in the 100mg group, and 39.0% in the 200mg group. For the secondary measures, the reported data shows that at week 24 the proportions reaching that same joint improvement threshold were 34.1% (placebo), 56.1% (25mg), 57.1% (100mg), and 39.0% (200mg). For a higher level of joint improvement (50%), the figures at week 16 were 7.3% (placebo), 29.3% (25mg), 35.7% (100mg), and 17.1% (200mg). For skin improvement — specifically a 75% reduction in a psoriasis scoring system — the reported figures at week 16 were 14.6% (placebo), 12.2% (25mg), 16.7% (100mg), and 4.9% (200mg). The reported data also shows that for physical functioning (measured by a standard questionnaire where a meaningful improvement is a drop of at least 0.3 points on a 0–3 scale), 36.6% of the placebo group and 48.8%, 45.2%, and 39.0% of the three clazakizumab groups respectively showed that level of improvement at week 16. Quality-of-life scores (on a 0–100 scale where higher means better) showed small changes across all groups, with the data not indicating notably large differences between groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02317627 · results posted 1 November 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02317627) tested a drug called belumosudil (also referred to as KD025) in people with psoriasis. Participants were divided into three groups receiving different doses: 400 mg once daily, 200 mg twice daily, or 400 mg twice daily. A total of 38 people started the trial — 13, 13, and 12 in each group respectively — and 27 completed it. The trial used a standard psoriasis scoring system called the PASI (Psoriasis Area and Severity Index), which runs from 0 (no psoriasis) to 72 (very severe psoriasis), to track changes in participants' skin over 12 weeks. The reported data shows that, looking at all participants together, around 11% achieved at least a 75% reduction in their PASI score by the end of treatment, while about 37% achieved at least a 50% reduction. Among those who completed the full course of treatment (the "evaluable" group), those figures were reported as approximately 15% and 46% respectively. The reported average PASI score across all participants fell by about 6.6 points from a starting average of around 12.3. After just four weeks, roughly 68% of all participants were reported to have had some decrease in their PASI score. Regarding side effects (called adverse events), the reported data shows that across all participants, 50% experienced a moderate (Grade 2) adverse event and 55% experienced a severe (Grade 3) adverse event, though the data does not break down further which specific events occurred. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04572997 · results posted 24 September 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT04572997) enrolled 21 adults with a skin condition called palmoplantar pustulosis — a type of psoriasis that causes pustules (pus-filled blisters) on the palms of the hands and soles of the feet. Twenty of the 21 participants completed the study. The trial was measuring changes in skin severity and quality of life over 20 weeks using several scoring tools, including the PPPASI (a scale from 0 to 72 where higher numbers mean more severe disease) and the DLQI (a quality-of-life questionnaire scored from 0 to 30, where higher numbers mean a bigger impact on daily life). The reported data shows that the average PPPASI score at the start of the study was 16.50, and by week 20 it was reported as 7.65 (in the main analysis group). Regarding the number of participants reaching certain improvement thresholds: 7 out of 21 participants were reported to have achieved at least a 50% reduction in their PPPASI score at week 12, rising to 12 participants by week 16, and 13 participants by week 20. For a 75% reduction in score, the reported data shows 2 participants at week 12, 6 at week 16, and 3 at week 20. The average DLQI (quality-of-life) score was reported as 8.50 at the start of the study and 2.00 by week 20. The reported data also shows an average reduction in pustule count of approximately 76% from the beginning to the end of the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02852967 · results posted 13 September 2021
According to the results reported on ClinicalTrials.gov, this trial tested an investigational medicine called belumosudil in people with psoriasis. A total of 110 people took part across five groups — four groups received different doses or schedules of belumosudil, and one group received a placebo (a dummy treatment with no active ingredient). The trial used a standard psoriasis scoring tool called the PASI (Psoriasis Area and Severity Index), where a score of 0 means no psoriasis and 72 means very severe psoriasis. The main thing being measured was how many participants had their PASI score reduce by 75% or more after 16 weeks — a benchmark commonly used in psoriasis research. The reported data shows that, at 16 weeks, the percentage of participants who reached that 75% improvement mark (using a method that carried forward the last available reading for anyone who had dropped out) ranged from about 8.7% to 19.0% across the belumosudil dose groups, compared with 16.7% in the placebo group. Among only those who completed the full 16 weeks, the figures ranged from about 7.1% to 23.5% in the belumosudil groups, compared with 30.0% in the placebo group. The reported data also shows changes in the raw PASI score from the start of the trial to week 16: average scores fell by between approximately 4.5 and 5.7 points across all belumosudil groups, and by about 5.7 points in the placebo group. A separate quality-of-life questionnaire (scored 0–30, where lower is better) showed average score reductions of between 2.2 and 3.4 points across the belumosudil groups, and 4.0 points in the placebo group, at week 16. The number of participants rated "clear" or "almost clear" by their doctor at week 16 was small across all groups — ranging from 0 to 2 people per belumosudil group, and 2 people in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03895372 · results posted 27 August 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03895372) tested an investigational medicine called PF-06826647 in people with psoriasis — a skin condition. Participants were given either a placebo (a dummy treatment with no active ingredient) or one of several daily doses of PF-06826647 (50 mg, 100 mg, 200 mg, or 400 mg). A total of 178 people started the first part of the trial, spread across eight groups. The trial had two parts: an initial 16-week treatment period, followed by an extension period running to around week 40. One of the key things being measured was the proportion of participants whose psoriasis skin score (called PASI 90 — meaning at least a 90% improvement in the overall severity of their psoriasis patches) improved by week 16. The trial also tracked medical events that occurred during the extension period. The reported data shows that for the primary skin-score measure at week 16, the percentage of participants reaching a 90% improvement in their psoriasis score was 0% across the placebo group and most active-dose groups, with one exception: 2.2% of participants in the 200 mg dose group reached that threshold. For the extension period (weeks 16 to 40), the reported data shows that medical events of any kind (called adverse events) were recorded in varying numbers across groups — for example, 11 people in one placebo-then-200 mg group, 26 people in the group that stayed on 400 mg throughout, and similar figures in other groups. Medical events considered by investigators to be related to the study treatment were also counted, ranging from 0 to 10 participants depending on the group. Abnormalities in blood, chemistry, and urine test results were reported in only a very small number of participants across groups, with most groups reporting zero such abnormalities. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00691002 · results posted 26 August 2021
According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called LEO 80190 for psoriasis affecting the face and skin fold areas (such as the groin, armpits, and under the breasts). The first part of the trial ran for 8 weeks and compared four groups: LEO 80190 (353 people), calcipotriol alone (342 people), hydrocortisone alone (363 people), and a vehicle (an inactive version of LEO 80190, 181 people). A second, open-label part ran for 52 weeks where 454 participants all received LEO 80190. Across both parts, over 1,200 people were enrolled in total. The reported data shows that for the main measurement — how many people's facial psoriasis was rated as "controlled" (meaning clear or almost clear) by a doctor after 8 weeks — 158 out of 353 people in the LEO 80190 group met this standard, compared with 135 out of 342 in the calcipotriol group, 115 out of 363 in the hydrocortisone group, and 41 out of 181 in the vehicle group. At the 4-week mark, the reported numbers were 101 (LEO 80190), 66 (calcipotriol), 61 (hydrocortisone), and 14 (vehicle). For a separate score measuring redness, thickness, and scaliness of the face at 8 weeks, 171 people in the LEO 80190 group reached the "success" threshold, compared with 136, 131, and 42 in the other three groups respectively. For skin fold areas at 8 weeks, the reported data shows that 80 people in the LEO 80190 group were rated as having "controlled disease" compared with 55, 48, and 14 in the other groups. Using the redness/thickness/scaliness score for skin folds, 82 people in the LEO 80190 group reached "success," compared with 81, 59, and 15 in the calcipotriol, hydrocortisone, and vehicle groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03358290 · results posted 6 August 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03358290) tested four different doses of an investigational medicine called JTE-051 (50 mg, 100 mg, 150 mg, and 200 mg) against a placebo (a dummy treatment with no active ingredient) in people with psoriasis. A total of 13 people started the trial — 2 in the lowest dose group, 3 each in the 100 mg, 150 mg, and 200 mg groups, and 2 on placebo. The main thing the trial was measuring was the proportion of participants whose psoriasis skin score (called the PASI score, a 0–72 scale where higher numbers mean more severe disease) improved by at least 75% by the end of treatment. The reported data shows that, for the primary goal — a 75% or greater improvement in PASI score — zero participants in any group, including placebo, reached that threshold. For the secondary measures, the reported data shows that average PASI scores did change from the start to week 12: the 50 mg group showed roughly an 18% reduction, the 100 mg group about 28%, the 150 mg group about 33%, and the 200 mg group about 34%, while the placebo group showed no change (0%). When looking at whether participants achieved a 50% improvement in their PASI score, none in the 50 mg, 100 mg, or 150 mg groups reached that level, while 50% of participants in the 200 mg group did. No participants in any group achieved a 90% or 100% improvement. For the doctor's overall skin assessment (sPGA), where a score of 0 or 1 means cleared or minimal symptoms, 50% of participants in the 200 mg group reached that level, while no participants in the other groups or placebo did. It is worth noting that this was a very small trial — most groups had only 2 or 3 participants — so the reported percentages represent just one or two individuals in some cases. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03668613 · results posted 23 July 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03668613) enrolled 84 people in total — 42 in a lower-dose group and 42 in a higher-dose group — who received a medicine called secukinumab (also referred to in the data as AIN457). The trial was measuring changes in psoriasis severity, using two main scoring tools: the PASI score (a 0–72 scale that combines how much skin is affected and how severe the patches are) and the IGA score (a 0–4 scale where a doctor rates overall skin clearance). By the end of the study, 31 people in the low-dose group and 36 in the high-dose group completed the full trial. The reported data shows that, for the main outcomes, 39 out of 39 assessed participants in each group achieved a PASI 75 response — meaning their PASI score had dropped by at least 75% from where it started. For the IGA measure (a score of 0 or 1, meaning clear or almost clear skin), 33 out of 33 assessed participants in the low-dose group and 35 out of 35 in the high-dose group met that threshold. For a secondary outcome looking at a 90% or greater reduction in the PASI score, 29 participants in the low-dose group and 32 in the high-dose group were reported to have reached that level. The reported data also shows that drug levels measured in the blood were higher in the high-dose group across all measured time points. Regarding unintended medical events that occurred during the study, 33 participants in the low-dose group and 35 in the high-dose group experienced at least one such event; no deaths were reported in either group. It is worth noting that the numbers assessed for the main outcomes (39 in each group) appear lower than the number who started (42 in each group), and the data as submitted does not fully explain this difference. Any figures not included in the submitted data have not been assumed or guessed here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03364309 · results posted 25 June 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03364309) enrolled 438 adults with plaque psoriasis across three starting groups: 88 people received a placebo (dummy treatment), 174 received ixekizumab every four weeks, and 176 received ixekizumab every two weeks. The trial tracked participants through several stages — an initial dosing period, a maintenance period, and for some, a re-treatment period and follow-up — to measure how psoriasis lesions responded to different dosing schedules of the study drug compared to placebo. The main things being measured were changes in overall skin appearance as rated by a doctor, and the extent to which psoriasis-affected skin area improved. The reported data shows that, for the two primary measures at the end of the initial dosing period, a much higher proportion of participants in the ixekizumab groups met the targets compared to those receiving placebo. For the doctor's overall skin rating (sPGA), 3.4% of placebo participants achieved a score of "clear" or "minimal," compared to 79.9% in the every-four-weeks group and 86.4% in the every-two-weeks group. For the skin coverage improvement score (PASI 75 — meaning at least a 75% reduction in the area and severity of psoriasis), 8.0% of placebo participants reached this level, compared to 87.4% and 93.8% in the two ixekizumab groups respectively. The reported data also shows that for complete skin clearance as rated by the doctor, 0% of placebo participants achieved this, compared to 35.6% and 36.4% in the ixekizumab groups. For a 90% or greater improvement in the skin coverage score, figures were not fully reported in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03738163 · results posted 7 June 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 121 people who used a product called Epaderm Cream, which is a moisturising cream intended for dry skin. Of those who started, 114 completed the trial and 7 did not finish. The trial was measuring things like how participants felt about their skin moisture, softness, and dryness after using the cream, based on their own answers to questionnaires. The reported data shows that all 114 participants who completed the trial answered "strongly agree" or "agree" when asked whether their skin moisturisation had improved — this was the main thing the trial set out to measure. For the additional measures, 82 out of 114 completing participants reported improved skin softness, and 100 out of 114 reported improved overall dry skin (by rating their skin as showing no scaling or only faint scaling). The reported data also shows that 101 participants rated the overall comfort of the treatment as "good" or "excellent." Regarding how often the cream was used, 67 participants reported applying it twice a day. Ten participants were recorded as having experienced an adverse device effect — that is, an unwanted reaction that was considered related to use of the cream — though the nature or severity of those reactions was not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03421197 · results posted 11 May 2021
According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called PPC-06 for people with psoriasis, a skin condition that causes red, scaly patches. A total of 426 people took part, split across four groups: one group took PPC-06 at 400 mg once a day, one took 400 mg twice a day, one took 600 mg twice a day, and one took a placebo (a dummy treatment with no active ingredient). The trial ran for 24 weeks and measured two main things: how many people saw their psoriasis severity score drop by 75% or more (using a standard scoring tool called the PASI), and how many people's skin was rated as "clear" or "almost clear" by a doctor (using a separate scale called the IGA). The reported data shows the following results at the end of week 24. For the 75% improvement in skin severity score: roughly 39.7% of people in the once-daily 400 mg group, 47.2% in the twice-daily 400 mg group, and 44.3% in the twice-daily 600 mg group reached that level, compared with 20.0% in the placebo group. For the "clear or almost clear" skin rating: approximately 35.7% in the once-daily 400 mg group, 41.4% in the twice-daily 400 mg group, and 44.4% in the twice-daily 600 mg group received that rating, compared with 22.0% in the placebo group. It is worth noting that not all participants completed the study — between 56 and 68 people finished in each group out of the 105–107 who started. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03535194 · results posted 30 March 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,484 participants across five groups to compare two investigational medicines — mirikizumab (tested at different doses) — against an existing treatment called secukinumab and a placebo (an inactive dummy treatment) in people with moderate-to-severe plaque psoriasis. The trial ran in two main stages: an induction period (early treatment phase) and a maintenance period (longer-term treatment phase), followed by a post-treatment follow-up. The trial was primarily measuring how many participants' skin improved significantly by the end of the induction period, using two standard psoriasis scoring tools used by doctors and researchers. The reported data shows that, for the two main (primary) measures taken at the end of the induction period, 79.7% of participants in the 250mg mirikizumab group and 76.3% in the secukinumab group had their skin rated as clear or near-clear by their doctor (with at least a two-point improvement on the doctor's scoring scale), compared with 6.3% in the placebo group. Using the other primary measure — a scoring system that looks at the area of skin affected and how severe the patches are — 74.4% of the mirikizumab group and 72.8% of the secukinumab group showed at least a 90% improvement in their overall skin score, compared with 6.3% in the placebo group. For the secondary measures, the reported data shows broadly similar patterns: for example, around 89.5% of both the mirikizumab and secukinumab groups showed at least a 75% improvement in that same skin score, versus 8.0% in the placebo group. Smaller proportions of participants across all active treatment groups reported their psoriasis symptoms (such as itch, pain, stinging, and burning) dropping to zero, and around 59–60% in the active treatment groups (versus about 6% for placebo) reported their quality of life reaching a score considered to have no meaningful impact on daily life. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03819218 · results posted 21 February 2021
According to the results reported on ClinicalTrials.gov, this trial involved 7 participants who all used a treatment called MC2-01 Cream. Six participants completed the study, while one did not finish. The trial was measuring two main things: whether the cream affected a hormone system in the body called the HPA (hypothalamic-pituitary-adrenal) axis — which controls how the body responds to stress and regulates certain hormones — and whether it changed calcium levels in the blood and urine. These are standard checks used when studying creams that contain active ingredients similar to vitamin D or steroids. The reported data shows that at both the 4-week and 8-week marks, zero out of the participants tested showed suppression (a dampening down) of the HPA axis. To check this, participants were given an injection of a substance called cosyntropin, and their blood cortisol levels (a hormone made by the adrenal glands) were measured 30 minutes later — suppression was defined as a cortisol level below a set threshold. The reported data also shows small changes in calcium levels: blood calcium (adjusted for a protein called albumin) changed by −0.037 mmol/L at week 4 and −0.027 mmol/L at week 8. The ratio of calcium to another substance in urine changed by +0.115 mol/mol at week 4 and +0.058 mol/mol at week 8. No further context or comparison figures were reported for these calcium measurements. It is worth noting that this was a very small study with only 7 participants, and the reported results reflect only what was measured in this specific group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03025542 · results posted 6 January 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03025542) involved 49 people with psoriasis who were split into two groups: 32 received bimekizumab 320 mg alongside a placebo (a dummy treatment with no active ingredient), and 17 received bimekizumab 320 mg on its own. Of those who started, 30 and 15 participants respectively completed the study. The trial was measuring two main things: how psoriasis severity scores changed over 28 weeks, and how much of the study drug was present in participants' blood at various points in time. The reported data shows that psoriasis severity was measured using a standard scoring tool called the PASI (Psoriasis Area and Severity Index), which runs from 0 to 72, where a higher number means more severe psoriasis. By week 28, the group receiving bimekizumab alongside a placebo had an average score change of −10.76 points from where they started, while the group receiving bimekizumab alone had an average change of −19.74 points. A negative number means scores went down (i.e. moved toward less severe) from the starting point. Regarding the amount of drug measured in the blood, the reported data shows no figures were available at the starting point (baseline) for either group. At week 2, average blood levels were 19.749 micrograms per millilitre in the placebo-combination group and 14.437 in the bimekizumab-alone group. These levels shifted at later time points — at week 4, week 8, and week 12 — with figures ranging roughly between 5 and 17 micrograms per millilitre across both groups, as detailed in the full results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02931838 · results posted 27 November 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 267 adults with moderate to severe psoriasis across six groups. Forty-five participants received a placebo (a dummy treatment with no active ingredient), while the remaining participants received different doses and schedules of an investigational medicine called BMS-986165 (now known as deucravacitinib). The trial ran for 12 weeks and was primarily measuring how many participants in each group saw their psoriasis severity score — called a PASI score, which rates the extent and seriousness of skin plaques — drop by at least 75% from where it started. The reported data shows that by week 12, around 6.7% of participants in the placebo group reached that 75% improvement mark. In comparison, the figures reported for the BMS-986165 groups ranged from 9.1% (at the lowest dose, taken every other day) up to 75.0% (at the highest once-daily dose). For the secondary measures, the reported data shows that a higher proportion of participants in the higher-dose groups also reached 50%, 90%, and 100% improvement thresholds compared with the placebo group. A doctor's overall skin clearance rating of "clear" or "almost clear" was reported in 6.7% of the placebo group, compared with between 20.5% and 75.6% across the BMS-986165 groups. Participants' self-reported quality-of-life scores and the percentage of body surface area affected by psoriasis also showed greater reductions from baseline in higher-dose groups compared with placebo, based on the reported figures. A PASI-100 result (complete clearance) was not separately reported in the data provided for that secondary outcome, so those figures are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02905006 · results posted 19 November 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02905006) enrolled 250 adults with psoriasis across six groups. Forty-two people received a placebo (a dummy injection with no active ingredient), while the remaining 208 received one of five different doses of a medicine called bimekizumab, given by injection every four weeks. The trial's main goal was to measure how many people in each group achieved at least a 90% improvement in their psoriasis skin score — a standardised measure called PASI that rates the redness, thickness, scaliness, and spread of plaques across the body — after 12 weeks. The reported data shows that at the 12-week mark, 0% of participants in the placebo group reached that 90% improvement threshold, compared with 46.2%, 67.4%, 75.0%, 79.1%, and 72.1% in the five bimekizumab dose groups (from lowest to highest dose, with the third group also receiving a higher starting "loading" dose). For the secondary measurements at week 12, the reported data shows that between 4.8% (placebo) and up to 86.0% (320 mg dose) of participants were rated by their doctor as "clear" or "almost clear" of psoriasis. When looking at a stricter measure — complete skin clearance (100% improvement in the PASI score) — the reported figures ranged from 0% in the placebo group to between 27.9% and 60.0% across the bimekizumab groups. Similar patterns in the reported numbers were also seen at the earlier 8-week check-in point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02749799 · results posted 5 October 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02749799) enrolled 45 people who used a betamethasone dipropionate spray (0.05%), known as DFD-01, for the treatment of psoriasis. Of those 45 participants, 37 completed the study and 8 did not. The trial was measuring three things over 14 days: how a doctor rated the overall severity of participants' psoriasis (using a scale called the Investigator's Global Assessment, or IGA), how much of the body surface area was affected by psoriasis, and how much the skin condition was impacting participants' everyday quality of life (using a questionnaire called the Dermatology Life Quality Index, or DLQI). The reported data shows the following changes from the start of the study to Day 14. On the IGA scale — where 0 means no disease and 4 means severe disease — the average score across participants dropped by 0.8 points, with a lower score indicating less severe disease at that point. The percentage of body surface area affected by psoriasis decreased by an average of 1.3 percentage points. On the DLQI questionnaire — where 30 represents the worst possible impact on quality of life and 0 represents the best — the average score fell by 6.6 points, with a lower score indicating a better quality of life rating. It is worth noting that there was only one group in this trial, so there was no comparison group reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03482011 · results posted 25 September 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03482011) looked at a medicine called mirikizumab (referred to here as "Miri") for people with psoriasis — a skin condition that causes red, scaly patches. In the first 16-week phase of the trial, 107 people received a dummy treatment (placebo) every four weeks, and 423 people received 250 mg of mirikizumab every four weeks. After that initial phase, participants were split into smaller groups for a further 36-week maintenance phase depending on how they had responded, and some then entered a 12-week follow-up period. The trial measured things like how much the skin condition improved on two standard rating scales used by doctors — the sPGA (a doctor's overall rating of psoriasis from clear to very severe) and the PASI (a combined score of how much skin is affected and how severe the patches are). The reported data shows the following results at the end of the 16-week induction period. For the two main (primary) outcomes: on the sPGA scale, 6.5% of placebo participants and 69.3% of mirikizumab participants reached a near-clear or clear rating; on the PASI 90 measure (skin patches at least 90% improved compared to the start), 6.5% of placebo participants and 64.3% of mirikizumab participants reached this threshold. The reported data also shows results for several secondary outcomes measured at the same time point: for PASI 75 (at least 75% improvement), two separate measurements were reported — one showing 0.9% (placebo) vs 17.0% (mirikizumab), and another showing 9.3% (placebo) vs 82.5% (mirikizumab); for PASI 100 (complete clearance of skin patches), 0.9% of placebo participants and 32.4% of mirikizumab participants reached this level; and for having 1% or less of body surface area affected by psoriasis, 0.9% of placebo participants and 49.2% of mirikizumab participants met this measure. The reason two separate PASI 75 figures were reported is not explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02407041 · results posted 7 September 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02407041) enrolled 5 participants, all of whom received the study drug GR-MD-02. All 5 participants completed the trial — none dropped out. The trial was measuring how many people experienced a significant improvement in their psoriasis symptoms, specifically using a scoring system called the PASI score (a standard way of rating how much of the body is affected by psoriasis and how severe it looks). The goal was to see how many participants achieved at least a 75% improvement in that score by a follow-up visit 30 days after treatment. The reported data shows that out of the 5 participants who received GR-MD-02 at a dose of 8 mg/kg, 1 participant reached the target of a 75% or greater improvement in their PASI score by the 30-day follow-up point. No other outcome measures were reported in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02592018 · results posted 27 August 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants, all of whom received a treatment called secukinumab. Thirteen participants completed the study, while two did not finish. The trial was measuring changes in certain immune cells — specifically, a type of white blood cell known as CD4+ T effector cells — looking at how many of these cells were producing a protein called IL-17 (a signalling molecule involved in the immune system). The study also looked at changes in gene activity within those immune cells, using a method called RNA sequencing (a technique that reads which genes are switched on or off in cells). The reported data shows that, compared to the starting point (baseline), the percentage of those immune cells producing IL-17 changed by −1.42%, +0.23%, and −0.17% at different measured time points during the study — indicating small fluctuations in either direction. For the secondary measurements, which tracked how many genes in those immune cells changed their activity compared to baseline, the reported data shows three separate figures: 67 genes, 308 genes, and 1,618 genes showing changed activity at different points or under different comparisons. The trial data does not include additional detail explaining the different time points or comparisons these numbers correspond to, so further context was not reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02785185 · results posted 27 August 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02785185) enrolled 150 participants across four groups. They were assigned to one of four treatments applied to the skin: IDP-122 Lotion (60 people), Ultravate Cream (57 people), IDP-122 Vehicle Lotion (17 people), or IDP-122 Vehicle Cream (16 people). The "vehicle" products are versions of the lotions or creams that do not contain the active ingredient, and are used for comparison purposes. The trial was measuring how many participants showed a meaningful improvement in their skin condition after two weeks, as judged by a doctor using a standard 5-point rating scale called the Investigator's Global Assessment (IGA), where 0 means "clear" and 4 means "severe." The reported data shows that the main goal was to count how many people achieved what the trial called "treatment success" — meaning their IGA score improved by at least 2 points from the start of the trial, and their skin was rated as either "clear" or "almost clear" at the two-week mark. According to the results reported on ClinicalTrials.gov, 18 out of 60 participants in the IDP-122 Lotion group and 18 out of 57 participants in the Ultravate Cream group met this measure. In the comparison (vehicle) groups, 3 out of 17 participants in the IDP-122 Vehicle Lotion group and 1 out of 16 in the IDP-122 Vehicle Cream group met the same measure. No other outcome measures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02721966 · results posted 24 August 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02721966) enrolled 498 participants in total across five groups. Two groups received the study drug AIN457 (also known as secukinumab) — one at a 300 mg dose (167 people) and one at a 150 mg dose (165 people) — while the remaining participants received a placebo (dummy treatment). The trial was measuring how participants with a form of inflammatory spinal arthritis responded to the treatment at 12 weeks, using a set of standardised scoring tools that looked at things like spinal pain, morning stiffness, and physical function. The reported data shows that for the main outcome — the proportion of participants who met a defined level of improvement in their symptoms at 12 weeks (called the ASAS20 response, meaning at least a 20% improvement across multiple measures) — 62.9% of those in the 300 mg group and 66.3% in the 150 mg group met this threshold, compared with 31.2% in the placebo group. For a stricter version of this measure (ASAS40, requiring at least 40% improvement), the reported figures were 43.6% for the 300 mg group and 39.5% for the 150 mg group, versus 12.2% for placebo. A separate disease activity score (BASDAI50, meaning at least a 50% improvement on that scale) was reported at 37.4% for 300 mg and 32.7% for 150 mg, compared with 9.8% for placebo. The reported data also shows changes in spinal pain scores — measured on a 0–100 scale where higher numbers mean more pain — from the start of the trial to week 12. For general spinal pain at any time, the average score change was −26.5 points (300 mg), −28.5 points (150 mg), and −13.6 points (placebo). For night-time spinal pain, the reported changes were −30.2 points (300 mg), −30.3 points (150 mg), and −15.2 points (placebo). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02462122 · results posted 20 August 2020
According to the results reported on ClinicalTrials.gov, this trial involved 215 participants in total — 141 who used a lotion called IDP-118 and 74 who used a vehicle lotion (a lotion without the active ingredient, used as a comparison). Of those, 120 and 61 participants respectively completed the study. The trial was measuring what proportion of participants reached a result called "treatment success" — defined as their skin condition improving by at least two steps on a five-point scale (from 0 = clear to 4 = severe) and reaching either "clear" or "almost clear" by week 8. The reported data shows that at the main eight-week measurement point, around 45% of participants in the IDP-118 group met the treatment success definition, compared with around 13% in the vehicle lotion group. The reported data also shows results at earlier and later time points. At week 12, approximately 33% of the IDP-118 group and around 9% of the vehicle group met the treatment success definition. At week 6, those figures were roughly 38% and 8% respectively. At week 4, approximately 27% of the IDP-118 group and around 1% of the vehicle group met the definition, and at week 2 the figures were approximately 10% and 0%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02045277 · results posted 20 August 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02045277) enrolled 212 people in total across four groups. Participants were assigned to one of four lotions: IDP-118 Lotion (59 people), IDP-118 Monad HP Lotion (63 people), IDP-118 Monad Taz Lotion (59 people), or a Vehicle Lotion — sometimes called a placebo or inactive comparator — (31 people). The trial was measuring how many participants' skin condition, as rated by a clinician on a five-point scale (from 0 = clear to 4 = severe), improved significantly after using the assigned lotion over 12 weeks. The reported data shows that at the main eight-week check-in, the percentage of participants whose skin was rated "clear" or "almost clear" and had improved by at least two steps on that scale was: 52.5% in the IDP-118 Lotion group, 33.3% in the IDP-118 Monad HP Lotion group, 18.6% in the IDP-118 Monad Taz Lotion group, and 9.7% in the Vehicle Lotion group. The reported data also shows results at earlier time points. At week 2, those figures were 11.9%, 4.8%, 1.7%, and 0% respectively. At week 4, they were 25.4%, 17.5%, 1.7%, and 6.5%. At week 6, they were 32.2%, 25.4%, 15.3%, and 3.2%. Results for week 12 were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02785159 · results posted 20 August 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02785159) enrolled 152 people across four groups to test different topical (applied to the skin) treatments for a skin condition. The groups were: IDP-118 Lotion (62 people), Tazorac Cream (58 people), IDP-118 Vehicle Lotion — a lotion without the active ingredient (15 people), and IDP-118 Vehicle Cream — a cream without the active ingredient (17 people). The trial measured how many participants achieved "treatment success," meaning their skin condition improved significantly as rated by a clinician using a standardised 5-point scale called the Investigator Global Assessment (IGA), where 0 means "clear" and 4 means "severe." Treatment success required both a meaningful improvement of at least 2 steps on that scale and a final rating of "clear" or "almost clear." The reported data shows that, by the end of the study, 31.66% of participants in the IDP-118 Lotion group met the treatment success definition. In the Tazorac Cream group, 13.77% of participants met that definition. In the IDP-118 Vehicle Lotion group (no active ingredient), the figure was 15.90%, and in the IDP-118 Vehicle Cream group (no active ingredient), it was 7.96%. No secondary outcome measure data appears to have been submitted to ClinicalTrials.gov, so only this primary result is available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00714272 · results posted 14 August 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled a total of four people — two in the active treatment group, who received a procedure called granulocytapheresis (a process where blood is filtered to remove certain white blood cells), and two in a control group who received a sham (dummy) version of the same procedure. The trial was looking at whether this approach could reduce the severity of psoriasis, a skin condition, as measured by a scoring tool called the PASI (Psoriasis Area and Severity Index), which rates how widespread and severe psoriasis patches are across the body. All four participants completed the study. The reported data shows that the primary outcome — the number of participants whose PASI score improved by 75% or more — was zero in both groups. The secondary outcome, which looked at the number of participants whose PASI score improved by at least 50%, was also zero in both groups. In other words, the reported numbers show that none of the four participants in either group reached either of these improvement thresholds by the end of the trial. It is worth noting that with only four participants in total, this was an extremely small study, and the reported data does not allow for broad conclusions to be drawn. No data was reported on side effects or safety outcomes in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03469336 · results posted 25 June 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 18 people with psoriasis, and 17 of them completed the study. All participants received multiple treatments applied to different patches of skin — three different strengths of an investigational topical medicine called PF-06763809 (2.3%, 0.8%, and 0.23%), a vehicle (an inactive base cream with no active ingredient), and a combination of two existing medicines (calcipotriene and betamethasone). The trial was primarily measuring changes in the thickness of the affected skin layer (called the "psoriatic skin infiltrate"), as well as monitoring participants for any unwanted medical events, unusual blood/urine test results, heart tracing (ECG) changes, and changes in blood pressure or pulse. The reported data shows that skin infiltrate thickness — measured in micrometres (millionths of a metre) — appeared to change over the course of treatment across all groups, including the inactive vehicle group. For example, at one time point the reported thickness values were 0.89 µm for the 2.3% dose, 0.92 µm for the 0.8% dose, 0.97 µm for the 0.23% dose, and 0.93 µm for the vehicle group. A secondary measure — the total "area under the curve" of skin thickness over time (a way of capturing the overall amount of change across all measurement days) — was reported as approximately 6,192 units for the 2.3% dose, 5,996 for the 0.8% dose, 6,922 for the 0.23% dose, and 6,205 for the vehicle. Regarding monitoring: 6 out of 18 participants experienced at least one unwanted medical event during the study period; no participants had abnormal laboratory test results flagged under the pre-specified criteria (with only isolated single-participant findings noted in some categories); no participants had concerning vital signs readings; and a small number (up to 2 participants) had some heart tracing measurements that met certain pre-specified threshold criteria, though no participant reached the highest concern thresholds. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02294981 · results posted 18 June 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 4 participants, all of whom were in a single group receiving what was described as "Conventional Dosing/Plaque Based Dosing." The trial was measuring a skin condition called psoriasis, using a scoring tool called the Modified Psoriasis Area Severity Index (MPASI) — a scale that rates psoriasis based on how thick, red, and scaly the affected skin patches are, and how much of the skin is involved. Three of the four participants completed the trial, while one did not finish. The reported data shows that no numerical measurements for the primary outcome — the MPASI score — were submitted to ClinicalTrials.gov. This means it is not possible to describe what the scores showed, as the figures were simply not reported in the structured results data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03210961 · results posted 31 March 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 109 participants across a range of groups. It was an early-phase study testing different doses of an investigational drug called PF-06826647, compared against a placebo (a dummy treatment with no active ingredient). Participants were split into several groups: some received single doses only (called the SAD, or Single Ascending Dose, phase), some received the drug repeatedly over a period of time (the MAD, or Multiple Ascending Dose, phase), and some had psoriasis and received the drug over a longer period. The trial was measuring things like blood pressure, pulse rate, and results of physical examinations — tracking how many participants had readings that fell outside pre-set thresholds of concern. The reported data shows that, for blood pressure and pulse rate checks during the single-dose phase, small numbers of participants across groups had readings that met the pre-specified alert thresholds — for example, 2 participants in the placebo group and 2 in the 3 mg dose group were noted in one category of vital sign criteria. In the repeat-dosing phase, similarly small numbers were recorded — generally 0 or 1 participant per group meeting those thresholds. In the psoriasis groups, the reported data shows slightly more instances: for example, up to 7 participants in the 400 mg psoriasis group and 5 in the 100 mg psoriasis group had pulse rate readings meeting the pre-set criteria. For physical examination findings considered noteworthy by the investigating doctor, the reported numbers were very low — mostly zero across all groups and phases, with just 1 participant in the 400 mg psoriasis group noted across the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03614078 · results posted 30 March 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03614078) enrolled 92 adults in total across three groups: 31 received a lower dose of the investigational treatment PRCL-02 (25 mg), 30 received a higher dose (50 mg), and 31 received a placebo (a dummy treatment with no active ingredient). The trial was measuring whether PRCL-02 could reduce the severity of psoriasis over 12 weeks, using a standard skin scoring system called the PASI — which runs from 0 (no disease) to 72 (most severe). The main goal was to see how many participants achieved at least a 75% improvement in that score (known as "PASI 75"). The reported data shows that after 12 weeks, 4 out of 31 participants in the 25 mg group, 1 out of 30 in the 50 mg group, and 0 out of 31 in the placebo group reached that 75% improvement threshold. Regarding unwanted health events that occurred during the study (called "treatment emergent adverse events"), the reported data shows these were recorded in 14 participants in the 25 mg group, 12 in the 50 mg group, and 10 in the placebo group. The trial also measured how the drug moved through the body — for example, how much of it was present in the bloodstream and how quickly it reached its peak level. The reported data shows the peak blood concentration was higher in the 50 mg group (2,220 ng/mL) than the 25 mg group (984 ng/mL), and the time to reach that peak was 4 hours and 2 hours respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02514577 · results posted 27 January 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02514577) enrolled 217 participants in total — 143 in the IDP-122 Lotion group and 74 in the IDP-122 Vehicle Lotion group (a "vehicle" lotion is one that contains no active ingredient, similar to a placebo). The trial was measuring how many participants with psoriasis achieved "treatment success" — defined as their skin condition being rated "clear" or "almost clear" by a clinician, with at least a two-step improvement on a five-point severity scale — after using either the active lotion or the vehicle lotion for eight weeks. Areas such as the face, scalp, hands, and feet were not included in these assessments. The reported data shows that at the main eight-week check-in (the primary outcome), 36.5% of participants in the IDP-122 Lotion group met the treatment success definition, compared with 8.13% in the vehicle lotion group. The trial also tracked treatment success at earlier and later time points as secondary outcomes. The reported figures were: at Week 2, 7.06% (IDP-122 Lotion) versus 0% (vehicle); at Week 4, 19.81% versus 2.77%; at Week 6, 30.14% versus 7.93%; and at Week 12 — four weeks after the treatment period ended — 19.48% versus 6.69%. These numbers reflect the proportion of participants who met the success criteria at each of those time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02515097 · results posted 27 January 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02515097) enrolled 213 participants across two groups: 142 people received IDP-122 Lotion (the treatment being studied) and 71 received IDP-122 Vehicle Lotion (a lotion without the active ingredient, used for comparison). The trial was measuring how many participants achieved what researchers called "treatment success" — meaning their skin condition, as rated by a clinician on a 0-to-4 scale, improved by at least two steps and reached a rating of "clear" or "almost clear." This rating was assessed on body areas excluding the face, scalp, palms, soles, and a few other areas. The reported data shows that at the main eight-week measurement point, approximately 38% of participants in the IDP-122 Lotion group met the "treatment success" definition, compared with approximately 12% in the Vehicle Lotion group. The trial also tracked these ratings at earlier and later time points. The reported data shows that at week 2, around 5% of the IDP-122 Lotion group and 0% of the Vehicle Lotion group met the success definition. By week 4, those figures were approximately 19% and 0.2%; at week 6, approximately 28% and 4%; and at a follow-up check at week 12 (four weeks after the eight-week treatment period), approximately 23% of the IDP-122 Lotion group and 9% of the Vehicle Lotion group still met the definition. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01708603 · results posted 6 January 2020
According to the results reported on ClinicalTrials.gov, this trial looked at a skin condition called moderate to severe plaque psoriasis. It enrolled 1,831 participants across four groups: 612 people received brodalumab at a 210 mg dose, 610 received brodalumab at a 140 mg dose, 300 received ustekinumab (another existing treatment used for comparison), and 309 received a placebo (an inactive injection). The trial measured three things at the 12-week mark: a doctor's overall impression of the skin (called the sPGA score), the proportion of participants whose psoriasis area and severity improved by at least 75% (PASI 75), and the proportion whose psoriasis cleared completely (PASI 100). The reported data shows the following participant counts meeting each measure at week 12. For the doctor's overall skin assessment (sPGA), the numbers recorded as "clear or almost clear" were: 481 out of 612 in the 210 mg brodalumab group, 354 out of 610 in the 140 mg brodalumab group, 183 out of 300 in the ustekinumab group, and 12 out of 309 in the placebo group. For the 75% improvement measure (PASI 75), the reported numbers were 528, 406, 210, and 25 respectively across the same groups. For complete clearance (PASI 100), the reported numbers were 272, 157, 65, and 2 respectively. The data does not include the percentage figures themselves, only the raw participant counts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01708629 · results posted 3 January 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT01708629) enrolled 1,881 adults with plaque psoriasis across four groups: 624 received brodalumab 210 mg, 629 received brodalumab 140 mg, 313 received ustekinumab (another medicine used for psoriasis), and 315 received a placebo (an inactive treatment). The trial was primarily measuring two things at the 12-week mark: how many participants saw their psoriasis skin score improve by at least 75% (using a standard scale called the PASI, which runs from 0 meaning no disease to 72 meaning the worst possible disease), and how many were rated by their doctor as having skin that was clear or almost clear. The reported data shows that, for the 75% skin improvement measure at week 12, 531 participants in the 210 mg brodalumab group, 435 in the 140 mg brodalumab group, 217 in the ustekinumab group, and 19 in the placebo group reached that threshold. For the doctor's "clear or almost clear" rating at week 12, the reported figures were 497 participants in the 210 mg brodalumab group, 377 in the 140 mg brodalumab group, and 13 in the placebo group. The data does not appear to include a reported figure for the ustekinumab group on this second measure. The vast majority of participants in all groups completed the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01060098 · results posted 2 January 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 48 people across three groups: 25 with Rheumatoid Arthritis, 15 with Ankylosing Spondylitis, and 8 with Psoriatic Arthritis. All 48 participants completed the study with no drop-outs. The trial was measuring a specific type of immune cell — called "Th17 cells" — in the bloodstream. These are a kind of white blood cell thought to play a role in inflammatory conditions. The study used two laboratory techniques to count how many of these cells were present in participants' blood samples. The reported data shows two sets of measurements for each group, likely representing different time points or testing methods, though the data as submitted does not label these separately. For the first set of measurements, the reported figures were 466.4 units for the Rheumatoid Arthritis group, 432 units for the Ankylosing Spondylitis group, and 450 units for the Psoriatic Arthritis group. For the second set, the reported figures were higher: 759.8 units for the Rheumatoid Arthritis group, 651 units for the Ankylosing Spondylitis group, and 609 units for the Psoriatic Arthritis group. These numbers represent counts of immune cell activity per one million blood cells. No secondary outcome measures were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03462927 · results posted 24 December 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 63 people in total — 32 in the MC2-01 Cream group and 31 in the comparison group (CAL/BDP Combination). Of those, 26 and 29 people respectively completed the study. The trial was measuring how much of the active ingredients — calcipotriene and betamethasone dipropionate, as well as a related substance called MC1080 — entered the bloodstream after the creams were applied to the skin. This type of measurement is often done to understand how a product is absorbed by the body. The reported data shows the peak blood levels (the highest amount detected in the blood at any point after application, referred to as "Cmax") for each substance. For calcipotriene, the reported average peak blood level was 30.2 pg/mL (picograms per millilitre — a very small unit of measurement) for MC2-01 Cream and 30.0 pg/mL for the comparison product. For betamethasone dipropionate, the reported figures were 21.5 pg/mL for MC2-01 Cream and 23.1 pg/mL for the comparison. For the related substance MC1080, the reported figures were 29.8 pg/mL for MC2-01 Cream and 29.2 pg/mL for the comparison. Separate measurements for MC2-01 Cream alone were also reported: 30.0 pg/mL, 20.0 pg/mL, and 29.1 pg/mL respectively for each substance. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02125279 · results posted 29 November 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 54 participants, all of whom received a calcitriol 3 mcg/g treatment (a topical ointment containing a form of vitamin D). Of the 54 who started, 41 completed the study, and 13 did not finish. The trial was measuring changes in a blood protein called albumin — a protein naturally found in the blood that can be used to check how the body is responding to a treatment — at several points over about 30 weeks. The reported data shows that the main thing being tracked was how much participants' serum (blood) albumin levels changed from the start of the study. The results, measured in grams per litre (g/L), were: at week 4, a change of −1.0 g/L; at week 8, −1.0 g/L; at week 12, −0.8 g/L; at week 20, −1.1 g/L; at week 26, −0.8 g/L; and at week 30 (a follow-up point after treatment ended), −0.2 g/L. A negative number here means albumin levels were slightly lower compared to where they started. No comparison group data was reported, as there was only one group in this trial. No secondary outcome data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02584855 · results posted 15 November 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02584855) enrolled 394 participants who were given the study drug ixekizumab in an initial open-label phase (meaning everyone knew what they were receiving). Of those, 158 participants who showed a strong enough response — reaching what researchers called "minimal disease activity" (MDA), a score combining measures of joint tenderness, swelling, skin involvement, pain, and physical function — were then randomly assigned to either continue on ixekizumab (79 people) or switch to a placebo (79 people) in a blinded withdrawal phase, where neither participants nor researchers knew who was receiving which treatment. A further 133 participants who responded but did not meet the exact criteria for randomisation continued on ixekizumab without being randomised. The trial was measuring how long it took for participants to "relapse" — meaning they no longer met the MDA threshold. The reported data shows that for the primary outcome — time to relapse — a median figure of 22.29 weeks was reported for the placebo group, while no median figure was calculable for the ixekizumab group (this typically occurs when more than half of the group had not relapsed by the end of the study period, meaning the data was not reported as a single number). For the key secondary outcome, the reported data shows that 40.5% of participants in the ixekizumab group and 86.1% of participants in the placebo group were recorded as having relapsed during the blinded withdrawal period. For individual components of MDA, the reported time to loss of response for tender joint count was 64.29 weeks in the ixekizumab group and 22.29 weeks in the placebo group. For swollen joint count, no median was calculable for the ixekizumab group, while 28.71 weeks was reported for the placebo group. Similarly, for the skin-scoring measures (PASI and body surface area), no median figure was calculable for the ixekizumab group; the placebo group showed 36.00 weeks for PASI, and the body surface area figure was not reported for either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00456092 · results posted 23 October 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 204 adults with psoriatic arthritis across three groups during the main 12-week treatment phase: 67 people received apremilast 40 mg once daily, 69 received apremilast 20 mg twice daily, and 68 received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring how many participants showed a meaningful improvement in joint tenderness, joint swelling, and at least three other disease-related measures — a standard set of criteria known as an "ACR 20 response" (meaning at least a 20% improvement across those measures). A number of additional measures of joint disease activity were also tracked as secondary goals. The reported data shows that, at the end of the 12-week treatment phase, 35.8% of participants in the once-daily apremilast group and 43.5% in the twice-daily group met the ACR 20 response criteria, compared with 11.8% in the placebo group. For a stricter measure requiring at least 50% improvement (ACR 50), the reported figures were 13.4% and 17.4% for the two apremilast groups respectively, versus 2.9% for placebo. An even stricter 70% improvement threshold (ACR 70) was met by 7.5% and 5.8% in the apremilast groups, compared with 1.5% for placebo. Using a separate scoring tool called PsARC, around 50–52% of participants in both apremilast groups showed a response, versus 22.1% in the placebo group. The reported data also shows that adverse events (unwanted health events recorded during the study) were experienced by 58, 59, and 55 participants in the once-daily apremilast, twice-daily apremilast, and placebo groups respectively; serious adverse events were recorded for one participant in each group. The data was not reported in a way that breaks down the full detail of adverse event types. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01100034 · results posted 8 October 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01100034) enrolled 72 participants, all of whom received a medicine called etanercept. The study was set up to track a range of safety-related events over time — specifically, whether participants experienced serious infections, certain uncommon ("opportunistic") infections, cancers, and other unwanted medical events while taking the treatment. Of the 72 people who started, 29 completed the study and 43 did not finish. The reported data shows that, among the participants followed prospectively (that is, tracked going forward from the start), zero participants were recorded as experiencing a serious infection, an opportunistic infection of interest, or a malignancy (cancer). When it came to unwanted medical events more broadly, 26 out of the prospective participants experienced at least one adverse event (an unexpected medical occurrence during treatment), and 3 experienced a serious adverse event — meaning one that was life-threatening, required a hospital stay, or caused lasting harm. Regarding stopping treatment early, 3 participants discontinued during the first phase of treatment (the initial 24-week-or-more period), and a further 4 stopped after that phase. Among those who completed the initial treatment period and moved into a follow-up phase, the reported data shows approximately 17.9% went on to use etanercept again and approximately 26.7% used some other systemic (whole-body) therapy. For the one secondary (additional) outcome reported, the data shows that participants who did go back onto etanercept after the initial treatment period used it for an average of around 146 weeks, though the context and number of people this figure is based on were not fully detailed in the submitted data. Any further breakdown of these figures was not reported in the data available on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03090100 · results posted 1 October 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT03090100) compared two treatments for psoriasis — guselkumab (100 mg) and secukinumab (300 mg). A total of 1,048 people started the trial (534 in the guselkumab group and 514 in the secukinumab group). The main thing researchers were measuring was the proportion of participants whose psoriasis skin scores improved by at least 90% (known as a "PASI-90 response") by week 48. The PASI is a scoring system where a higher number means more severe psoriasis, running from 0 to 72. The reported data shows that for the primary measure at week 48, 84.5% of participants in the guselkumab group and 70.0% in the secukinumab group had achieved at least a 90% improvement in their psoriasis score. For the secondary measures, the reported figures were: at week 12, 69.1% of the guselkumab group and 76.1% of the secukinumab group had achieved a 90% improvement; at week 48, 58.2% of the guselkumab group and 48.4% of the secukinumab group had achieved a full 100% improvement in their score. When looking at participants who maintained at least a 75% improvement at both week 12 and week 48, the reported figures were 84.6% for guselkumab and 80.2% for secukinumab. A separate assessment by the treating doctor (called the Investigator's Global Assessment) recorded completely clear skin at week 48 in 62.2% of the guselkumab group and 50.4% of the secukinumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02752776 · results posted 25 September 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02752776) enrolled 1,660 adult participants with psoriasis across three groups: 663 people who had not previously used any biologic or non-biologic systemic treatment (Group A – "naïve"), 673 who had previously used non-biologic systemic treatments (Group B), and 324 who had previously used biologic treatments (Group C). The trial measured how participants' skin condition and quality of life changed over 52 weeks, using several questionnaires and scoring tools to assess things like how much psoriasis affected daily life, how much skin was affected, and participants' general sense of their own health. The reported data shows that at week 16, the primary measure — a skin-related quality of life score called the DLQI, where a score of 0 or 1 means the condition had little to no impact on daily life — was reached by around 74.7% of Group A, 71.3% of Group B, and 61.7% of Group C, with 70.8% of all participants combined reaching that score. At week 52, similar figures were reported: 75.3% for Group A, 73.3% for Group B, and 62.0% for Group C (71.9% overall). For skin clearance, the reported data shows that at week 16, between 85.4% and 94.4% of participants across groups had at least a 75% reduction in their skin-affected surface area score (known as PASI 75), and between 69.0% and 82.4% had at least a 90% reduction (PASI 90). For a general health self-rating scale (scored 0–100, with higher meaning better), participants reported average increases of roughly 19 to 21 points at week 16 and 20 to 23 points at week 52 across the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03255382 · results posted 13 September 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT03255382) enrolled 120 people with psoriasis — 60 in each group. One group took Fumaderm (an older oral tablet treatment) and the other received risankizumab (an injectable treatment). The trial ran for 24 weeks and was mainly measuring how many participants achieved a 90% reduction in their psoriasis severity score — a standardised scale called the PASI (Psoriasis Area and Severity Index), where a higher score means more severe psoriasis. All 60 people in the risankizumab group completed the trial, while 13 of the 60 in the Fumaderm group did not finish. The reported data shows that at 24 weeks, 83.3% of participants in the risankizumab group had their PASI score reduce by 90% or more from where it started, compared with 10.0% in the Fumaderm group. The trial also tracked how many participants reached a 50% reduction in their PASI score at several earlier time points. The reported figures for that measure were: at week 4, 53.3% (risankizumab) versus 6.7% (Fumaderm); at week 8, 91.7% versus 28.3%; at week 12, 100% versus 46.7%; at week 16, 100% versus 60.0%; and at week 20, 100% versus 63.3%. It is worth noting that when participants dropped out, their results were counted as "non-responders" — meaning those missing figures were treated as if the treatment had not worked for them. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01445886 · results posted 28 August 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 33 people with nail psoriasis, and 28 of them completed the study. The five who did not finish did not have their reasons detailed in the reported data. The trial compared two treatments applied to the nails — an indigo naturalis oil extract and a calcipotriol solution — over 24 weeks. It measured changes in nail psoriasis severity using scoring systems that rate how much of each nail is affected by psoriasis-related changes such as pitting, thickening, and discolouration. The reported data shows that for the main scoring tool (called the shNAPSI, which runs from 0 to 40 for one hand, where higher means more severe), both groups started with very similar scores — around 27 out of 40. After 24 weeks, the indigo naturalis group's average score dropped to 14.4, while the calcipotriol group's average score dropped to 20.4. For the most severely affected single nail (scored separately on a scale of 0 to 96), starting scores were again similar (17.7 vs 16.9), and after 24 weeks these came down to 5.9 and 9.5 respectively. For the secondary outcome measuring how doctors and patients themselves rated overall improvement on a 0–5 scale, the reported data shows the indigo naturalis group averaged around 3.7 (doctor) and 3.4 (patient), while the calcipotriol group averaged around 2.5 (doctor) and 2.3 (patient). On this scale, scores of 3 or above were described as a positive response. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02168933 · results posted 20 August 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 8 participants, all placed into a single study group. Seven of the 8 participants completed the trial, while one did not finish. The trial was measuring the severity of nail psoriasis (a condition where psoriasis affects the fingernails or toenails) using two different scoring tools — one assessed by a clinician and one reported by the patients themselves. Participants were split into an "Active" group and a "Sham" (inactive or pretend treatment) group for comparison purposes. The reported data shows that on the clinician-scored nail psoriasis scale (called the Modified NAPSI), where 0 means no nail disease and 13 means the most severe disease possible, the Active group scored an average of 6.3 and the Sham group scored an average of 6.0. For the patient-reported scale, where 0 means no nail disease and 100 means the most severe, the Active group reported an average score of 58.6 and the Sham group reported an average of 55.4. It is important to note that the data as submitted does not make clear whether these scores were measured at the start, the end, or as a change over time during the trial, so caution is needed in interpreting what the numbers represent. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02195349 · results posted 16 August 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02195349) enrolled 67 participants in total across all groups. The study tested a drug called GSK2831781 at several different dose levels — ranging from very low (0.0003 mg/kg) up to higher doses (5 mg/kg) — and compared them against a placebo (an inactive dummy treatment). Participants were either healthy volunteers or people with psoriasis, a skin condition. The trial was an early-phase study primarily focused on tracking a range of body measurements — including blood test results, vital signs such as heart rate and blood pressure, heart tracings (ECGs), and any unwanted medical events — to see how participants responded to the drug. All 67 participants who started the trial completed it. The reported data shows that, for blood test abnormalities considered potentially clinically important (meaning results that fell outside pre-set ranges of concern), small numbers of participants were recorded across most groups. For example, 3 out of 14 placebo-treated healthy volunteers and 1 out of 6 participants in the highest GSK2831781 dose group (5 mg/kg) had blood count readings outside those ranges. For blood chemistry (such as sugar, salt, and mineral levels), the numbers with out-of-range readings ranged from 0 to 3 participants per group. For vital signs, between 0 and 2 participants per group had readings outside the pre-set concern ranges. For heart tracings (ECGs), between 0 and 3 participants per group had readings outside those ranges. Regarding unwanted medical events (called adverse events), the reported data shows that 8 of 14 placebo healthy volunteers and between 3 and 9 participants in the various GSK2831781 groups experienced at least one such event; no separate serious adverse event numbers were listed for individual groups in the submitted data. The trial also measured levels of certain proteins in the blood (including IL-6, IL-8, interferon-gamma, and TNF-alpha, which are markers of inflammation) — changes from the starting point were small across all groups, ranging roughly from 0 to 15 picograms per millilitre, with the psoriasis placebo group showing the largest reported average change (approximately 15 pg/mL). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01899729 · results posted 2 August 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01899729) looked at a drug called IMO-8400 compared to a placebo (an inactive substance used as a comparison). A total of 46 people took part, split across four different dosing groups of IMO-8400 (with 8–9 people in each) and one placebo group (11 people). The main thing the trial was set up to measure was the safety and tolerability of IMO-8400 — in other words, how many unwanted health events (called adverse events) occurred during the trial, whether or not they were thought to be related to the treatment. The reported data shows the number of adverse events recorded in each group. For adverse events considered related to treatment, the four IMO-8400 groups reported 6, 6, 6, and 5 events respectively, while the placebo group reported 6 events. For adverse events not considered related to treatment, the four IMO-8400 groups reported 3, 3, 2, and 4 events respectively, while the placebo group reported 5 events. No secondary outcome measure data appears to have been submitted, so those figures are not available to describe. It is also worth noting that not everyone who started the trial finished it — between 6 and 9 people completed the study in each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01101100 · results posted 18 July 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01101100) enrolled 181 people, all of whom received the study drug AMG 827 in an open-label format (meaning everyone knew which treatment was being given — there was no comparison or placebo group). Of those 181 participants, 126 completed the study and 55 did not finish. The trial was measuring two things related to a skin condition (psoriasis): a doctor's overall rating of skin appearance using a scale called the sPGA (Static Physician's Global Assessment), and a separate scoring system called PASI (Psoriasis Area and Severity Index), which takes into account how much of the body is affected and how severe the skin changes look. The reported data shows that, at the relevant measurement point, 66 out of 181 participants (that is the number reported — the data does not specify this as a percentage of completers or the full group) had a doctor's rating of "clear" or "almost clear" on the sPGA scale. Separately, the reported data shows a mean (average) percent change in PASI scores of −85.7%, meaning that on average across participants, the PASI score went down by about 85.7 points in every 100 from where it started — and the trial notes that a decrease in this score represents an improvement in the skin condition being measured. It is worth noting that because this was an open-label study with no comparison group, the reported numbers describe what was observed in this one group only. No data from a placebo or alternative treatment group was reported for comparison. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02826603 · results posted 9 July 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02826603) enrolled 1,102 adults with psoriasis — 550 in a group receiving secukinumab (300 mg) and 552 in a group receiving ustekinumab (45 mg or 90 mg, depending on body weight). The trial was measuring skin clearance at various points in time using two main tools: the PASI score (a 0–72 scale rating how much of the body is affected and how severe the lesions are, where a lower score means less disease) and the IGA score (a 0–4 scale where a doctor rates overall skin appearance, with 0 meaning clear skin). By the end of the study, 489 participants in the secukinumab group and 488 in the ustekinumab group had completed the trial. The reported data shows the following numbers at the 12-week mark for the two main (primary) outcomes. For a 90% or greater reduction in PASI score: 366 out of 550 participants in the secukinumab group and 265 out of 552 in the ustekinumab group reached this level. For the IGA score of 0 (clear) or 1 (almost clear): 397 secukinumab participants and 306 ustekinumab participants met this measure. For the secondary outcomes, at week 12, a 75% or greater PASI reduction was reported in 484 secukinumab participants and 409 ustekinumab participants. At the earlier four-week check, that same 75% PASI reduction was reported in 221 secukinumab participants and 90 ustekinumab participants. At week 16, complete skin clearance (100% PASI reduction) was reported in 250 secukinumab participants and 147 ustekinumab participants, and an IGA score of 0 or 1 was reported in 432 secukinumab participants and 326 ustekinumab participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02690701 · results posted 9 July 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02690701) enrolled 91 people in total — 46 received the medication secukinumab (given as an injection under the skin) and 45 received a placebo (an inactive dummy injection). The trial ran in two back-to-back treatment periods, and by the end, 41 people in the secukinumab group and 37 in the placebo group had completed both periods. The main thing the trial was measuring was inflammation in the large blood vessel called the aorta, using a specialised type of body scan (FDG-PET/CT) that detects how much sugar is taken up by inflamed tissue. This was assessed at 12 weeks. The trial also looked at several blood markers, including a general inflammation marker (CRP), cholesterol, and proteins linked to body fat and diabetes risk. The reported data shows that, for the main measurement — aortic inflammation expressed as a "target to background ratio" (a number comparing activity in the artery wall to activity in the blood) — the secukinumab group started at about 1.66 and changed by roughly +0.014 over the study period, while the placebo group started at about 1.63 and changed by roughly +0.066. For the secondary blood marker measurements, the reported changes from starting levels were: CRP (inflammation marker) changed by approximately −1.0 mg/L in the secukinumab group and +1.2 mg/L in the placebo group; cholesterol changed by approximately +10.6 mg/dL versus −8.5 mg/dL; adiponectin (a fat-related protein) changed by approximately +1,595 ng/mL versus −1,076 ng/mL; apolipoprotein B changed by approximately +0.002 ng/mL in both groups; and fetuin A changed by approximately +90,810 ng/mL versus +45,731 ng/mL. These are the numbers as submitted — the data does not include any further statistical context beyond these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02294227 · results posted 2 July 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02294227) enrolled 341 people in total — 114 received secukinumab 150 mg with a loading dose schedule, 113 received secukinumab 150 mg without a loading dose, and 114 received a placebo (an inactive treatment). The trial was measuring responses in people with psoriatic arthritis, looking at things like joint swelling and tenderness, skin involvement, and quality of life over 16 weeks. By the end of the study, 89, 88, and 95 participants had completed the study in each group respectively. The reported data shows that for the main outcome — the number of people who achieved at least a 20% improvement in joint swelling, tenderness, and related measures (called an "ACR20 response") — 47 out of 114 participants in the secukinumab loading-dose group, 45 out of 113 in the no-loading-dose group, and 21 out of 114 in the placebo group met this threshold at Week 16. For a higher bar of at least 50% improvement (ACR50), the reported numbers were 26, 19, and 7 participants respectively. The reported data also shows that a skin severity score measuring psoriasis coverage and intensity (PASI75, meaning at least a 75% improvement in that score) was reached by 29, 27, and 5 participants across the three groups. A general disease activity score (rated on a scale where higher numbers mean more severe disease) changed by −0.98, −0.84, and −0.21 points from the start of the study in each group. A quality-of-life physical score (where higher numbers indicate better physical wellbeing, out of 100) changed by +3.42, +3.44, and +0.63 points respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01094717 · results posted 26 June 2019
According to the results reported on ClinicalTrials.gov, this trial looked at treatments for psoriasis — a skin condition causing raised, scaly plaques. It compared two oral or topical medicines (acitretin and tazarotene gel) each used alongside either a real excimer laser treatment (a targeted light therapy) or a sham (fake) laser, to see how much the psoriasis plaques changed over 12 weeks. In total, 13 people took part — 3 in the acitretin-plus-laser group and 10 in the tazarotene-plus-laser group — and all 13 completed the trial. The reported data shows the main thing measured was the percentage change in a psoriasis plaque score (the NPF score, rated from 0 meaning no disease to 30 meaning worst disease), where a bigger percentage reduction means greater improvement in the plaque. The acitretin combined with real excimer laser group showed a reported mean reduction of 64.0%, compared to 52.1% for acitretin combined with the sham laser. The tazarotene gel combined with real excimer laser group showed a reported mean reduction of 32.7%, compared to 26.9% for tazarotene with the sham laser. For a secondary measure looking at how many participants reached a near-clear skin score at week 12, the reported data shows only 1 participant (in the acitretin and real excimer group) reached that level, while no participants in the other three groups did. Regarding reported adverse events (unwanted side effects), the data shows 2 participants in each of the acitretin groups and 4 participants in each of the tazarotene groups had adverse events recorded, though the specific types were not detailed in the submitted results. It is worth noting that this was a very small trial, and the reported numbers reflect only the participants enrolled. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02684370 · results posted 18 June 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02684370) enrolled 506 people with psoriasis across two parts. In Part A, participants were randomly assigned to receive either a placebo (102 people), a medicine called ustekinumab (100 people), or risankizumab (304 people). After Part A concluded, participants moved into Part B, where they continued or switched treatments across three groups totalling 493 people. The trial was measuring changes in skin condition using two main tools: the PASI score (a 0–72 scale rating how much of the body is affected and how severe the patches are, where lower is better) and the sPGA (a doctor's overall rating of skin severity from 0 = clear to 4 = severe). The reported data shows the following for the two primary outcomes at Week 16, comparing risankizumab to placebo. For the first primary outcome — the proportion of participants whose PASI score improved by at least 90% from the start — 75.3% of those in the risankizumab group reached this level, compared with 4.9% in the placebo group. For the second primary outcome — the proportion rated by their doctor as "clear" or "almost clear" on the sPGA scale — 87.8% of the risankizumab group reached this rating, compared with 7.8% in the placebo group. The reported data also shows results for several secondary outcomes at Week 16, again comparing risankizumab to placebo. A full 100% improvement in the PASI skin score was recorded for 35.9% of the risankizumab group versus 0% in the placebo group. A "completely clear" skin rating from the doctor was recorded for 36.8% of the risankizumab group versus 2.0% in the placebo group. On a quality-of-life questionnaire (scored 0–30, where 0–1 means psoriasis had no impact on daily life), 65.8% of the risankizumab group reached a score of 0 or 1, compared with 7.8% in the placebo group. On a symptom questionnaire measuring pain, redness, itching, and burning (scored 0–16), 29.3% of the risankizumab group reported a total score of zero (no symptoms), compared with 2.0% in the placebo group. No outcome data was reported for the ustekinumab group in the measures listed here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02672852 · results posted 28 May 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02672852) looked at a medicine called risankizumab for people with psoriasis, a skin condition. The trial ran in several stages. In the first stage (Part A1), 100 people received a placebo (a dummy treatment with no active ingredient) and 407 received risankizumab. Those who continued moved into a second stage (Part A2), and then a third stage (Part B), where participants were placed into different groups depending on how their skin had responded — bringing the total number of people involved across all stages to over 1,000. The trial was measuring changes in skin condition using two main scoring tools: the PASI score (which rates the extent and severity of psoriasis on a scale of 0 to 72, where higher means worse) and the sPGA score (a doctor's overall rating of disease severity, from 0 meaning clear skin to 4 meaning severe). The reported data shows the following for the first 16 weeks of the trial. For the PASI score, 73.2% of people in the risankizumab group achieved at least a 90% reduction in their score, compared with 2.0% in the placebo group. Looking at an even higher bar — a full 100% reduction — 47.2% of the risankizumab group reached that level, versus 1.0% in the placebo group. At the 75% reduction mark, 88.7% of the risankizumab group met this threshold, compared with 8.0% in the placebo group. For the sPGA score at week 16, 83.5% of people on risankizumab were rated as "clear" or "almost clear" by their doctor, compared with 7.0% in the placebo group; and 46.4% of the risankizumab group were rated fully "clear," versus 1.0% in the placebo group. The reported data also shows results at week 52 for a subgroup of people who had responded to risankizumab and were then randomly assigned to either continue on risankizumab or switch to placebo. Of those who continued on risankizumab, 87.4% were still rated "clear" or "almost clear" at week 52, compared with 61.3% of those who had been switched to placebo. Where data for certain measures or subgroups was not collected or not reported in the submitted results, those figures are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02134210 · results posted 13 May 2019
According to the results reported on ClinicalTrials.gov, this trial compared two medicines for plaque psoriasis — the established treatment Enbrel (etanercept) and a medicine called CHS-0214, which was being tested as a biosimilar (a very close copy of an existing medicine). A total of 260 people were assigned to the Enbrel group and 261 to the CHS-0214 group at the start. The trial ran in two parts: the first 12 weeks, and then a longer follow-up period out to 48 weeks. The main thing being measured was how much participants' psoriasis improved, using a scoring system called the PASI (Psoriasis Area and Severity Index), which rates the extent and severity of skin involvement. The reported data shows that at 12 weeks — the trial's primary check-in point — 142 out of 260 participants in the Enbrel group and 147 out of 261 in the CHS-0214 group had their PASI score improve by at least 75% from where they started. In terms of average percentage improvement in PASI scores at 12 weeks, the Enbrel group showed a mean reduction of 73.4% and the CHS-0214 group showed a mean reduction of 76.7%. The reported data also shows that at later time points (weeks 4, 8, 24, 36, and 48), both groups continued to show reductions in their PASI scores, with the average improvements ranging roughly from around 42% at week 4 up to around 83% at week 24, with numbers remaining broadly similar between the two groups across the follow-up period. A doctor's overall rating of disease severity (on a 0–5 scale, where lower is better) also showed reductions from baseline in both groups at each time point measured, with both groups recording an average drop of around 2.1–2.2 points by week 12 and beyond. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02394561 · results posted 23 April 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 431 adults with psoriasis — 185 who carried a genetic marker called HLA-Cw6 (referred to as "Cw6-positive") and 246 who did not carry it ("Cw6-negative"). All participants received the same treatment, a medicine called AIN457 at a dose of 300 mg. The trial was looking at whether this genetic marker made a difference to how people responded to the treatment. It had a main (core) phase and a follow-on (extension) phase, with the large majority of participants completing both phases. The reported data shows that the primary thing being measured was the proportion of participants whose psoriasis skin score (called PASI, a 0–72 scale where higher numbers mean more severe disease) improved by 90% or more after 16 weeks. According to the results, 80.4% of the Cw6-positive group and 81.7% of the Cw6-negative group reached that level of improvement. For secondary measures, the reported data shows that the middle (median) time for participants to reach a 90% improvement in their PASI score was 57 days in the Cw6-positive group and 58 days in the Cw6-negative group; for a 75% improvement, it was 29 days in both groups. Scores on a quality-of-life questionnaire (DLQI, rated 0–30 where higher means more impact on daily life) were reported to have decreased by around 8–9 points across measured time points for all participants combined. Scores on anxiety and depression questionnaires also showed reported decreases over the course of the trial, though the specific time-point figures varied. The reported data shows that changes in a doctor's overall severity rating (IGA, a 0–4 scale) were also tracked, with both groups showing percentage reductions from their starting scores at each visit — reaching around 79% reduction by the later time points reported. Results for the anxiety, depression, and quality-of-life measures were not broken down by genetic marker group, as the trial had pre-specified they would be reported for all participants together. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01952015 · results posted 15 March 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01952015) enrolled 12 participants, all of whom received the study drug AIN457 (also known as secukinumab). The trial was measuring how many people with generalised pustular psoriasis — a serious skin condition — showed an overall improvement in their condition at different points in time. Improvement was judged using a tool called the Clinical Global Impression (CGI), where a doctor rated how much a patient's condition had changed. The trial ran in three periods: an early treatment phase, a maintenance phase, and a third treatment period. The reported data shows that at week 16 (the main measurement point), 10 out of 12 participants were recorded as having "treatment success" — meaning their doctor rated them as at least "minimally improved." At week 52, the reported data shows 10 out of 12 participants again met that same measure of treatment success, while 2 participants had missing data and were counted as not having responded. At the end of the full trial, 8 out of the 9 remaining participants were recorded as having treatment success. The reported data also includes scores on a Japanese skin disease severity scale (the JDA score, rated 0–17 where higher means worse), with average scores appearing to decrease over time from around 2 at the start toward 0 at later timepoints — though the full set of individual visit figures is complex and not all timepoints are clearly labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03441789 · results posted 13 March 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT03441789) enrolled 28 people with psoriasis, split evenly into two groups of 14. One group received Otezla (a tablet medicine) combined with Enstilar foam (a topical treatment applied to the skin), while the other received Otezla combined with a vehicle foam — a foam containing no active ingredient, used as a comparison. The trial ran for 16 weeks and mainly measured how many participants achieved a 75% reduction in their psoriasis score, using a standardised skin assessment tool called PASI (Psoriasis Area and Severity Index), which rates disease severity on a scale from 0 to 72. By the end of the trial, 13 people in the Enstilar group and 10 in the vehicle foam group had completed the full study. The reported data shows that at week 16 (the main measurement point), 7 out of 14 participants in the Otezla plus Enstilar group, and 2 out of 14 in the Otezla plus vehicle foam group, reached the 75% skin score improvement target. For secondary measurements, the reported data shows that at week 16, 4 participants in the Enstilar group and 2 in the vehicle group reached a 90% improvement in their skin score, while 1 participant in the Enstilar group and 0 in the vehicle group reached 100% improvement. Participants also rated their itch on a scale of 0–10 (lower is less itch) and their skin-related quality of life on a scale of 0–30 (lower is better). At week 16, the reported average itch scores were 3 for the Enstilar group and 4 for the vehicle group, while the reported average quality-of-life scores were 3 for the Enstilar group and 6 for the vehicle group. It is important to note that this was a small trial with only 14 participants per group, and the results above are simply the raw numbers submitted to the registry. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02993471 · results posted 12 March 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 28 participants, all of whom completed the first part of the study. In the second part, 27 received at least one dose and 26 completed it, with 2 not finishing. The trial was designed to measure how the drug ixekizumab might affect the way the body processes three other common "probe" medicines — midazolam, warfarin, and dextromethorphan. These probe medicines were chosen because they are broken down by specific liver enzymes (known as CYP450 enzymes), and researchers wanted to see whether ixekizumab changed how quickly those enzymes processed the drugs. The study tracked two things for each probe medicine: the highest concentration the drug reached in the blood (called Cmax), and a measure of the total drug exposure over time (called AUC, essentially the overall amount of drug the body was exposed to). The reported data shows the following numbers for peak blood concentration (Cmax): for midazolam, the figure was 4.56 ng/mL without ixekizumab, 4.92 ng/mL with a single 160 mg dose of ixekizumab, and 4.83 ng/mL with ongoing 80 mg doses of ixekizumab. For warfarin, the reported Cmax was 510 ng/mL alone, 525 ng/mL with a single ixekizumab dose, and 510 ng/mL with ongoing doses. For dextromethorphan, the figures were 0.691, 0.878, and 0.658 ng/mL respectively. For total drug exposure over time (AUC), the reported data shows: midazolam at 16.6, 15.9, and 15.4 ng·h/mL; warfarin at 17,600, 17,700, and 16,200 ng·h/mL; and dextromethorphan at 11.7, 12.6, and 8.53 ng·h/mL across the three conditions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01815424 · results posted 5 March 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 266 adults with psoriasis (a skin condition causing red, scaly patches). Participants were randomly assigned to one of three groups for the first 16 weeks: 90 people received a higher dose of tofacitinib (10 mg), 88 received a lower dose (5 mg), and 88 received a placebo (a dummy pill with no active medicine). After week 16, those who had been on placebo were switched to one of the two tofacitinib doses and continued until week 52. The trial was primarily measuring two things at week 16: how many participants' skin was rated by their doctor as "clear" or "almost clear," and how many achieved at least a 75% reduction in a standard skin-severity score called PASI (which combines measures of redness, thickness, and scaling across the body). The reported data shows that at week 16, 75.6% of participants in the higher-dose tofacitinib group and 52.3% in the lower-dose group had skin rated "clear" or "almost clear" by their doctor, compared with 19.3% in the placebo group. For the 75% reduction in the PASI skin-severity score, the reported figures were 81.1% (higher dose), 54.6% (lower dose), and 12.5% (placebo). An even stricter target — a 90% reduction in the PASI score — was reported for 60.0%, 35.2%, and 3.4% of participants respectively. The reported data also shows results for several secondary measures at week 16. The body surface area covered by psoriasis changed on average by −73.8% (higher dose), −54.4% (lower dose), and −2.3% (placebo). A quality-of-life questionnaire (scored 0–30, where lower is better) showed average score reductions of 9.1 points, 7.0 points, and 1.6 points in the same three groups. At the earlier check-in of week 4, the proportion rated "clear" or "almost clear" was 37.8% (higher dose), 19.3% (lower dose), and 1.1% (placebo). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03022045 · results posted 6 February 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT03022045) enrolled 17 people in Japan who had either Generalised Pustular Psoriasis (GPP — a rare form of psoriasis causing widespread pus-filled blisters) or Erythrodermic Psoriasis (EP — a severe form causing widespread redness and skin shedding). Participants were split into two groups: 9 received risankizumab 75 mg and 8 received risankizumab 150 mg. The trial mainly measured how many participants showed a recognised level of clinical improvement in their skin condition by week 16, using standardised doctor-assessed scoring tools. The reported data shows that, at week 16, 100% of participants in both dose groups — across both the GPP and EP groups — met the threshold for a clinical response on their respective scoring tools. For a secondary measure looking at a 90% reduction in a standard skin severity score (called PASI90, where a higher reduction means less visible disease), the reported data shows: among GPP participants, 100% of those on the 75 mg dose and 75% of those on the 150 mg dose reached this level at week 16; among EP participants, 60% of those on the 75 mg dose and 100% of those on the 150 mg dose reached this level at week 16. For the secondary outcomes measured at week 52, the data was not reported on ClinicalTrials.gov. It is worth noting that this was a very small trial — fewer than 20 people in total — which limits how broadly any numbers can be interpreted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03000075 · results posted 6 February 2019
According to the results reported on ClinicalTrials.gov, this trial tested a medicine called risankizumab in people with psoriasis (a skin condition causing red, scaly patches). The trial ran in two back-to-back parts. In Part A, 171 people took part — 58 received a dummy treatment (placebo), 58 received a 75 mg dose of risankizumab, and 55 received a 150 mg dose. After 16 weeks, those who had been on placebo moved across to receive risankizumab in Part B, joining the participants who continued their original risankizumab dose. Part B followed all participants out to 52 weeks in total. The trial used two main skin-score tools to track changes: one called PASI (which rates redness, thickness, and scaling across the body on a scale of 0–72, where higher means more severe) and another called sPGA (a doctor's overall rating of skin severity from clear to severe). The reported data shows the following for Part A (at 16 weeks): when measuring the proportion of participants whose PASI score fell by at least 90% from their starting point, about 1.7% of the placebo group reached that level, compared with 75.9% in the 75 mg risankizumab group and 74.5% in the 150 mg group. For the doctor's overall skin rating (sPGA) of "clear or almost clear" at 16 weeks, the reported figures were 10.3% for placebo, 86.2% for the 75 mg group, and 92.7% for the 150 mg group. Using a slightly less strict skin-score measure (a 75% reduction in PASI), the reported figures at 16 weeks were 8.6% for placebo, 89.7% for the 75 mg group, and 94.5% for the 150 mg group. For Part B (at 52 weeks), the reported data shows that participants who switched from placebo to risankizumab also reached high levels on these measures. Across all four Part B groups, the proportion reaching a 90% PASI improvement ranged from 81.5% to 92.7%, the proportion rated "clear or almost clear" by their doctor ranged from 84.5% to 96.3%, and the proportion reaching a 75% PASI improvement ranged from 88.9% to 100%. These figures are as reported, and the trial was not designed to draw comparisons between the Part B groups on these particular measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02412644 · results posted 28 January 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02412644) enrolled 29 people with psoriasis across two groups. The first group of 21 participants received apremilast (a tablet treatment for psoriasis) throughout the whole study, while the second group of 8 participants received apremilast for the first part of the study and then switched to a placebo (a dummy treatment with no active ingredient) for the second part. The trial was measuring skin improvement using a scoring tool called the PASI (Psoriasis Area and Severity Index), which rates how much of the body is affected and how severe the patches are. A "PASI 75" result means a person's score improved by at least 75% from where they started — a commonly used marker in psoriasis research. It is worth noting that a large number of participants did not complete the study — 15 out of 21 in the first group and 4 out of 8 in the second group. The reported data shows that for the primary outcome at week 36, 4 out of 21 participants in the apremilast-only group and 2 out of 8 participants in the apremilast-then-placebo group were recorded as maintaining a PASI 75 result. For the secondary outcomes, at week 12, before the groups were split, 16 out of the combined participants were reported as having reached a PASI 75 result. By week 36, only 1 participant in the apremilast-only group and 0 in the apremilast-then-placebo group achieved a PASI 90 result (a 90% improvement in score). Similarly, a doctor's overall rating of skin condition (called the Physician Global Assessment, or PGA) of "clear" or "almost clear" was recorded for 1 participant in the apremilast-only group and 0 in the apremilast-then-placebo group at week 36. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00867100 · results posted 16 January 2019
According to the results reported on ClinicalTrials.gov, this trial involved 84 participants across two parts (Part A and Part B). The study was testing different doses of an investigational treatment given either by injection under the skin (subcutaneous, or "SC") or directly into a vein (intravenous, or "IV"), compared to a placebo (a dummy treatment with no active ingredient). Part A focused mainly on monitoring participants for any unwanted events across a range of doses. Part B also tracked changes in a psoriasis skin scoring system called the PASI score — a scale from 0 (no disease) to 72 (most severe disease) — to see how scores shifted over time. The reported data shows that in Part B, the average percentage improvement in PASI scores from the start of the study to Day 43 varied across the groups. The placebo group showed a reported average improvement of around 19.9%, the 140 mg SC group showed approximately 17.7% improvement, the 350 mg SC group showed approximately 53.6% improvement, and the 700 mg IV group showed approximately 86% improvement. These are the numbers as submitted; what they mean clinically is not for this summary to judge. Regarding unwanted events that occurred during the treatment period, the reported data shows that in Part B, 4 out of 5 placebo participants, 3 out of 5 in the 140 mg SC group, 7 out of 8 in the 350 mg SC group, and 8 out of 8 in the 700 mg IV group had at least one such event recorded. In Part A, the numbers of participants with recorded events ranged from 3 to 14 across the various dose and placebo groups. The data does not provide a breakdown of what types of events occurred or how serious they were. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02735187 · results posted 8 January 2019
According to the results reported on ClinicalTrials.gov, this trial involved two groups of people with psoriasis — 25 participants in one group ("Group 30") and 26 in another ("Group 15"). Most participants finished the trial: 21 out of 25 in Group 30, and 25 out of 26 in Group 15. The trial was comparing blue light treatment applied to one area of skin against a vitamin D cream (the comparison treatment) applied to a different area of the same person's skin, over 12 weeks. Researchers measured changes in psoriasis severity using a scoring tool called the Local Psoriasis Severity Index (LPSI), which rates redness, skin thickness, and scaling on a scale of 0 to 12 — a lower score means milder symptoms. The reported data shows that, for the primary outcome in Group 30 at week 12, both the blue light-treated skin area and the vitamin D-treated skin area showed the same average change in LPSI score: −2.4 points (a negative number means the score went down from the starting point). In Group 15, the secondary LPSI outcome showed a change of −2.4 points for the blue light area and −2.5 points for the vitamin D area. For patients' own ratings of their psoriasis severity on a 0–10 scale, Group 30 reported changes of −3.82 (blue light) and −3.56 (vitamin D); Group 15 reported −2.92 (blue light) and −2.44 (vitamin D). Skin redness measured by a device called a Mexameter (scored 0–99) was reported at end of treatment rather than as a change from the start, with scores ranging from roughly 60 to 65 across all groups — the data as submitted does not include the baseline figures for direct comparison. The reported data also shows that participant satisfaction with the blue light device, measured by a standard usability questionnaire scored out of 100, was 88.62 for Group 30 and 89.00 for Group 15. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02362789 · results posted 28 December 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02362789) involved 130 participants and was conducted in two phases. In the first phase (weeks 0–16), all 130 participants received the study treatment (secukinumab), with 128 completing this stage. In the second phase (weeks 16–32), 80 of those participants were randomly assigned to continue either secukinumab (42 people) or a placebo — an inactive dummy treatment (38 people) — to see what happened when some participants stopped receiving the active treatment. The trial was measuring the intensity of itching (pruritus) that participants experienced. The reported data shows that the main outcome was itching intensity, scored on a scale from 0 to 100, where 0 means no itching at all and 100 means the worst imaginable itching. At week 32, the group that continued receiving secukinumab reported an average itching score of 8.8 out of 100, while the group that switched to placebo reported an average score of 27.1 out of 100. No other outcome measures were included in the data reported to ClinicalTrials.gov for this trial. It is worth noting that only one outcome measure was reported in the submitted data, and no additional safety or secondary outcome figures were available — so those results were either not reported or not submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01544595 · results posted 20 December 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01544595) involved people with psoriasis — a skin condition causing red, scaly patches — who had already responded to treatment with a medicine called secukinumab (also referred to in the data as AIN457) in an earlier part of the study. During the main phase reported here, participants were placed into groups receiving either a 150 mg or 300 mg dose of secukinumab, or a placebo (a dummy treatment with no active medicine). In total, across the groups tracked during the withdrawal period, over 1,000 people took part. The trial was primarily measuring how many people lost a meaningful level of skin improvement — specifically, losing what researchers called a "PASI 75 response," meaning their skin had previously improved by at least 75% compared to when they started. The reported data shows that, among participants who had been switched to placebo, more people lost that 75% skin improvement over time compared to those who stayed on the active medicine. Specifically, the reported cumulative rate of losing that level of improvement by around week 68 was approximately 74% for the placebo group previously on the 150 mg dose, and approximately 65% for the placebo group previously on the 300 mg dose. By comparison, the reported figures for those who continued on the active medicine were approximately 50% for the 150 mg group and approximately 25% for the 300 mg group. These are statistical estimates from a survival-type analysis — a method used to track how many people reach a particular outcome over a period of time. The reported data also shows percentage changes in skin severity scores over time. For participants continuing on the active medicine during the withdrawal period, the reported average reduction in skin severity scores ranged from roughly 83% to 92% across different time points, depending on the dose. For the placebo groups, the reported reductions ranged from approximately 79% to 96%, though these figures reflect observed data at specific points and the numbers of participants being assessed changed over time. Data on other measures, such as investigator-rated skin assessments, were also reported but detailed breakdowns across all time points were not fully provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02601469 · results posted 7 December 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02601469) involved 26 people in total, split across two groups: 25 participants in Cohort 1 and 1 participant in Cohort 2. The trial was looking at a treatment called DSXS1503 and measuring its effect on a body system called the HPA axis — this is a communication pathway between the brain and the adrenal glands (small glands that sit above the kidneys) that helps control the body's response to stress. Specifically, the trial was checking whether the treatment caused a kind of suppression, or "switching off," of this system, which can sometimes occur with certain medications. The reported data shows that at the end of the treatment period, participants were given a small injection and their cortisol levels (a hormone produced by the adrenal glands) were measured. In Cohort 1, 3 out of 25 participants showed signs of HPA axis suppression, while 21 out of 25 did not. In Cohort 2, the single participant did not show signs of suppression. No secondary outcome measure data appears to have been reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02933866 · results posted 6 December 2018
According to the results reported on ClinicalTrials.gov, this trial involved 371 people in total — 186 in the group using a treatment called DSXS Topical, and 185 in the group using a vehicle topical (a comparison product that does not contain the active ingredient, sometimes called a placebo). By the end of the study, 174 people in the DSXS group and 176 in the vehicle group had completed it. The trial was measuring how many participants in each group reached a specific skin-clearance target, assessed by a doctor using a standard rating scale, by around Day 29 of the study. The reported data shows that the main thing being measured — called "clinical success" — was defined as a participant's skin being rated as "clear" or "almost clear" by a doctor, and having improved by at least two steps on that rating scale compared to where they started. According to the results reported on ClinicalTrials.gov, 49 participants in the DSXS Topical group and 41 participants in the vehicle topical group met this definition of clinical success. No further breakdown of these numbers (such as percentages or statistical comparisons between the two groups) was included in the data submitted. It is worth noting that secondary outcome measure results were not included in the data provided, so only this one reported figure is available to describe here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02742441 · results posted 14 November 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02742441) involved 409 participants — 205 using a medicated foam called 122-0551 Foam and 204 using a vehicle foam (a foam without the active ingredient, used as a comparison). The trial was measuring how the two foams compared in treating plaque psoriasis, looking at overall skin appearance as rated by a clinician, as well as specific features of psoriasis such as scaling, redness (erythema), and skin thickening (plaque elevation). It also looked at itchiness and the area of skin affected. The reported data shows that, for the main outcome — the proportion of participants whose skin was rated a "treatment success" by a clinician using a five-point scale (where 0 = clear and 4 = severe) — 30.7% of those in the 122-0551 Foam group met this standard, compared with 7.4% in the vehicle foam group. For the individual skin features, the reported data shows that in the 122-0551 Foam group, 35.0% were rated a treatment success for scaling, 33.7% for redness, and 28.8% for plaque elevation; in the vehicle foam group, the corresponding figures were 9.9%, 9.8%, and 8.3% respectively. The reported data also shows some additional pre-specified measurements. At an earlier time point, treatment success on the overall clinician rating was recorded at 9.5% for the 122-0551 Foam group and 3.6% for the vehicle foam group. For itchiness, scores on a questionnaire (ranging from 5 = no itching to 25 = most severe) changed by an average of −4.3 points in the 122-0551 Foam group and −2.5 points in the vehicle foam group — meaning both groups reported lower itchiness scores by that point. The area of skin affected by psoriasis changed by −1.5 percentage points in the 122-0551 Foam group and −0.2 percentage points in the vehicle foam group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02038569 · results posted 6 November 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 107 participants, all of whom used a gel called LEO 80185. Of those, 102 completed the study and 5 did not. The trial was measuring several safety-related things: any unwanted reactions to the drug, whether the gel affected the body's ability to produce a stress hormone called cortisol (measured using a standard stimulation test), and whether it changed calcium levels in the blood. Cortisol and calcium are monitored in trials like this because some skin treatments can affect how the body regulates them. The reported data shows that across the group, a total of 8 adverse drug reactions (unwanted reactions thought to be linked to the treatment) were recorded — two of one type and one each of six other types. For the cortisol stimulation test at week 4, the reported data shows that 4 participants had a cortisol level at or below 18 micrograms per decilitre (a threshold used to flag a possible effect on the body's stress-hormone system) 30 minutes after the stimulation test, while 27 did not; the status of some participants was not reported. At week 8, 2 participants were at or below that threshold, 27 were not, and 2 others were in a separate category — the data does not provide further detail on what that category represents. Regarding calcium levels in the blood, the reported data shows a small average change from the start of the study: a decrease of 0.012 mmol/L by week 4, 0.008 mmol/L by week 8, and 0.003 mmol/L by the end of treatment overall. These are very small numerical changes, though what they mean clinically was not described in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02400749 · results posted 24 October 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 100 people with palmoplantar psoriasis (a form of psoriasis affecting the palms of the hands and soles of the feet). Participants were split into two groups of 50: one group received the medicine apremilast from the start, while the other group received a placebo (a dummy treatment with no active ingredient) for the first 16 weeks before switching to apremilast for the following 16 weeks. The trial was primarily measuring how many people in each group reached a score of 0 ("clear") or 1 ("almost clear") on a doctor's 0–5 severity rating scale at the 16-week mark. The reported data shows that at 16 weeks, 7 out of 50 participants in the apremilast group reached that clear or almost-clear score, compared with 2 out of 50 in the placebo group. For the secondary measures — other ways the doctors tracked skin severity — the apremilast group's average doctor-rated severity score dropped by 0.8 points on the 0–5 scale, while the placebo group dropped by 0.4 points. On a broader skin severity index (scored 0–72, where higher means worse), the apremilast group's average score fell by 7.4 points and the placebo group's fell by 3.6 points, both measured from the start of the trial to week 16. A measure of the surface area of skin affected showed a change of −0.1 in the apremilast group and no measurable change (0.0) in the placebo group. By week 32 — when both groups were receiving apremilast — the reported data shows 12 participants had reached a clear or almost-clear score, and the broader skin severity index had fallen by an average of 11.3 points from the original starting point in the apremilast group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01116895 · results posted 3 October 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 63 adults with psoriasis (a skin condition causing red, scaly patches). Participants were divided into four groups: three groups received different doses of an investigational tablet called LEO 22811 (0.5 mg, 1.5 mg, or 3.0 mg), while a fourth group received a placebo (a dummy tablet with no active ingredient). The trial's main focus was on measuring changes in a standard psoriasis scoring system called the PASI — a scale from 0 to 72 that rates the redness, thickness, and scaliness of psoriasis across different parts of the body, with higher scores indicating more severe disease. Not everyone completed the trial: 12, 8, 14, and 11 participants finished in the 0.5 mg, 1.5 mg, 3.0 mg, and placebo groups respectively. The reported data shows that, for the primary measure, all four groups had a reduction in their PASI score over the course of the trial. The placebo group showed an average reduction of 5.6%, the 0.5 mg group showed 7.6%, the 1.5 mg group showed just 0.3%, and the 3.0 mg group showed 12.7%. For the secondary measures, the number of participants whose PASI score dropped by at least 75% (a commonly used benchmark in psoriasis research) was 0 in the placebo group, 1 in the 0.5 mg group, 0 in the 1.5 mg group, and 2 in the 3.0 mg group. The reported data also shows that, based on the treating doctor's overall rating of disease severity, only 1 participant (in the 3.0 mg group) was rated as having their disease fully or almost fully "controlled" by the end of the study, while no participants in the other three groups reached that rating. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01698333 · results posted 26 September 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01698333) involved 25 participants, all in a single group labelled "122-0551." All 25 people who started the trial completed it, with no drop-outs recorded. The trial was measuring how the body's stress hormone system — known as the hypothalamic-pituitary-adrenal (HPA) axis — responded to a stimulation test. The HPA axis controls the release of a hormone called cortisol, which the body uses to respond to stress. Participants were given a substance called cosyntropin to stimulate this system, and their cortisol levels were measured 30 minutes later to see whether the response was "normal" or "abnormal." The reported data shows that of the 25 participants, 19 had a "normal" HPA axis response — meaning their cortisol level measured above the threshold of 18 micrograms per decilitre (a standard unit for measuring substances in the blood) after the stimulation test. The remaining 6 participants had an "abnormal" response, meaning their cortisol level was at or below that threshold. No other outcome measures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02886702 · results posted 29 August 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 855 people in total — 284 in the "Test" group (a treatment being compared), 286 in the "Reference" group (an already-approved treatment used as a comparator), and 285 in the "Placebo" group (an inactive treatment). The trial was measuring how participants' skin condition responded over 12 weeks, using two rating tools: the Investigator's Global Assessment (IGA), where a trained assessor rates disease severity on a numbered scale, and the Psoriasis Area Severity Index (PASI), which scores the appearance of a specific patch of skin. Around 235–236 people in each group completed the study. The reported data shows that for the main (primary) outcome — the proportion of participants whose skin was rated as having none, minimal, or mild disease on the IGA at 12 weeks — 60.8% of the Test group, 63.2% of the Reference group, and 56.0% of the Placebo group reached that rating. For the first secondary outcome, which looked at only the two best possible IGA scores (none or minimal disease), the reported figures were 17.5% in the Test group, 22.6% in the Reference group, and 16.4% in the Placebo group. For the second secondary outcome, which looked at how the target skin patch scored on the PASI scale at 12 weeks, 16.3% of the Test group, 22.2% of the Reference group, and 16.0% of the Placebo group had scores rated as clear or almost clear. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02749370 · results posted 27 August 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people, all of whom received the medication etanercept. By the end of the study, 66 participants had completed it, while 14 did not finish. The trial was measuring changes in psoriasis skin symptoms over time using a scoring system called the PASI (Psoriasis Area and Severity Index), which rates the redness, thickness, and scaliness of psoriasis patches across the body on a scale of 0 to 72 — where a higher number means more severe or widespread psoriasis. The main goal was to see what proportion of participants had at least a 75% reduction in their PASI score by week 12. The reported data shows that at week 12 — the primary measurement point — 41.6% of participants had achieved at least a 75% reduction in their PASI score (known as a "PASI 75 response"). Looking at how this figure changed across all scheduled check-ins during the study, the reported PASI 75 rates moved from 6.6% at the earliest visit up to 45.5% at the final visit. For a less strict threshold (at least a 50% reduction in score), the reported rates ranged from 23.7% at the first visit to a high of 74.0% at one mid-study visit, ending at 62.3% at the last visit. For a stricter threshold (at least a 90% reduction), reported rates ranged from 1.3% at the first visit up to 22.1% by the final visit. The reported data also shows that the average PASI score across participants improved by around 22% from the starting point at the first visit, rising to a peak improvement of about 60% at one later visit. A separate skin severity rating (sPGA), where a score of 0 or 1 means "clear" or "almost clear," showed that 3.9% of participants reached that level at the first visit, rising to 33.8% by the final visit. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02634801 · results posted 18 July 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02634801) enrolled 54 participants in each of three groups — one group received ixekizumab, one received fumaric acid esters, and one received methotrexate — giving 162 participants in total at the start. The trial was measuring how much a common psoriasis scoring system (called the PASI, which rates the extent and severity of skin plaques on a scale from 0 to 72) improved over 24 weeks of treatment, as well as a number of other skin and quality-of-life measures. It is worth noting that far fewer participants in the fumaric acid esters group completed the first 24-week period (23 out of 54) compared with the other two groups. The reported data shows that, by week 24, 90.7% of participants in the ixekizumab group, 22.2% in the fumaric acid esters group, and 70.4% in the methotrexate group had their PASI score improve by at least 75% from where it started — this was the trial's main measurement. For secondary measurements, the reported data shows that a 90% or greater improvement in the PASI score was recorded for 79.6%, 9.3%, and 38.9% of participants in those same three groups respectively, and a complete 100% improvement was recorded for 40.7%, 3.7%, and 13.0%. A separate physician-rated skin assessment (sPGA) reaching a score of clear or nearly clear was reported for 86.5%, 13.2%, and 51.9% of participants. A quality-of-life questionnaire (DLQI, scored 0–30 where lower means less impact on daily life) reaching the best possible range of 0–1 was reported for 63.0%, 14.8%, and 37.0% of participants in the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02346240 · results posted 18 July 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02346240) enrolled 559 adults with psoriasis across four starting groups: 57 received a placebo (an inactive dummy injection), 170 received etanercept, 165 received certolizumab pegol (CZP) at a dose of 200 mg every two weeks, and 167 received CZP at 400 mg every two weeks. The trial ran in three phases — an initial 16-week period, a maintenance period up to week 48, and a longer open-label period running to week 144 — and was measuring how participants' skin responded to these treatments over time using standardised scoring tools. The reported data shows that by week 12, the main measure — the proportion of people whose skin scoring (called PASI) improved by at least 75% from where it started — was 5.0% in the placebo group, 53.3% in the etanercept group, 61.3% in the CZP 200 mg group, and 66.7% in the CZP 400 mg group. For a secondary measure — the proportion of people whose doctor rated their skin as "clear" or "almost clear" with a meaningful improvement — the reported figures at week 12 were 1.9% (placebo), 39.2% (etanercept), 39.8% (CZP 200 mg), and 50.3% (CZP 400 mg). A further secondary measure looking at an even greater skin improvement of at least 90% (PASI90) was also recorded, though the full figures for that measure were not completely available in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01866592 · results posted 22 May 2018
According to the results reported on ClinicalTrials.gov, this trial was a single-arm, open-label extension study — meaning all participants received the same treatment (adalimumab, a medication used in certain inflammatory conditions) and both the participants and researchers knew what was being given. A total of 81 people enrolled, 58 completed the study, and 23 did not finish. The trial was measuring changes in inflammation in the large blood vessels near the heart (the aorta), as well as changes in certain blood markers related to heart and metabolic health, after up to 52–64 weeks of adalimumab treatment. Vascular inflammation was assessed using a specialised scan (FDG-PET/CT), which tracks how much a sugar-like tracer is taken up by the artery walls — a higher uptake suggesting more inflammation. The reported data shows that, when comparing the end of the adalimumab treatment period to measurements taken before the study began (the original baseline), vascular inflammation in five sections of the aorta changed by an average of −3.8% (a small decrease). When comparing the end of treatment to the point at which adalimumab was first started (rather than the original baseline), the reported change was approximately 0.02% — essentially no change. For the blood markers, the reported data shows average changes from original baseline as follows: total cholesterol increased by about 3.2 mg/dL; low-density lipoprotein particles (often called "LDL," a type of fat-carrying particle in the blood) increased by about 22.5 nmol/L; high-density lipoprotein particles (often called "HDL," another type of fat-carrying particle) decreased by about 3.0 nmol/L; and a measure of how well HDL particles remove cholesterol from cells (called cholesterol efflux capacity) decreased by 0.217 units. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02513550 · results posted 18 April 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02513550) enrolled over 1,200 participants across six dosing groups, all receiving a medicine called ixekizumab at 80 mg, but on different schedules — either every two weeks (Q2W), every four weeks (Q4W), or a combination of both. The trial focused on people with psoriasis, a skin condition that causes red, scaly patches. Two main things were measured at 52 weeks: how many participants had their skin assessed as "clear" or "nearly clear" by a doctor (called the sPGA score), and how many had at least a 75% reduction in the overall area and severity of their psoriasis patches (called PASI 75). The three main groups used for these primary measurements were the Q4W group (310 people), the Q4W/Q2W group (306 people), and the Q2W group (611 people). The reported data shows that for the primary outcomes at week 52, the percentage of participants recorded as having a "clear" or "nearly clear" skin assessment (sPGA of 0 or 1) was 70.6% in the Q4W group, 72.5% in the Q4W/Q2W group, and 78.6% in the Q2W group. For the PASI 75 measure — at least a 75% improvement in psoriasis coverage and severity — the reported figures were 79.0%, 83.7%, and 85.9% for those same three groups respectively. For the secondary outcomes, the reported data shows that a 90% improvement in the PASI score was recorded in 65.2%, 73.9%, and 79.5% of participants across the three groups, while a 100% improvement (completely clear skin by this measure) was recorded in 43.5%, 49.3%, and 59.7%. The reported average change in the overall PASI score from the start of the trial was a reduction of approximately 18.3, 19.0, and 19.4 points across the three groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02445807 · results posted 13 April 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02445807) involved 265 people in total — 176 who used a cream called DFD-06 and 89 who used a "vehicle cream" (a cream without the active ingredient, used as a comparison). All participants completed the trial with no dropouts recorded. The trial was measuring how well DFD-06 Cream reduced the severity of psoriasis over a short period, primarily looking at results at Day 15 (about two weeks in), and also at Day 8 (about one week in). The reported data shows that the main thing being measured was "treatment success," which the trial defined as a participant's psoriasis reaching a score of 0 or 1 on a severity scale (meaning clear or almost clear skin) and improving by at least 2 steps on that scale from where they started. At Day 15, the reported results show that 30.1% of people using DFD-06 Cream met this definition of treatment success, compared to 9.7% of people using the vehicle cream. At Day 8, the reported figures were 14.2% for the DFD-06 group and 1.6% for the vehicle cream group. The trial also measured the change in the area of skin affected by psoriasis — the reported data shows an average reduction of 25.1% in affected skin area for the DFD-06 group, compared to a 7.4% reduction in the vehicle cream group, by Day 15. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02718898 · results posted 23 March 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02718898) looked at a medicine called ixekizumab (given as an 80mg injection every two weeks) compared to a placebo (a dummy treatment with no active ingredient) in people with genital psoriasis. A total of 149 people started the blinded portion of the trial — 74 received placebo and 75 received ixekizumab. The trial then moved into an open-label phase (where everyone knew what treatment was being given) and a follow-up period. The main thing being measured was how many participants' genital psoriasis was rated by a doctor as either "clear" or "minimal" by the end of the blinded treatment period. The reported data shows that, for the primary measure — a doctor's rating of genital psoriasis as "clear" or "minimal" — 55 out of 75 participants in the ixekizumab group reached that rating, compared to 6 out of 74 in the placebo group. For the secondary measures, the reported data shows: 55 ixekizumab participants versus 2 placebo participants had their overall body psoriasis rated "clear" or "minimal"; 37 versus 5 reported at least a 3-point improvement in genital itch on a 0–10 scale; 29 versus 9 reported their sexual activity was "never" or "rarely" limited by their genital psoriasis; and 23 versus 9 reported they "never" or "rarely" avoided sexual activity because of it. For quality of life (measured on a 0–30 scale where higher scores mean worse quality of life), the ixekizumab group reported an average decrease of 9.7 points from their starting score, while the placebo group reported an average decrease of 1.4 points. It is important to note that these numbers describe what was measured and counted in this specific group of trial participants — they do not tell us about longer-term outcomes, and the trial design changed across its different phases. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
-
NCT01807520 · results posted 13 March 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01807520) enrolled 198 people with nail psoriasis across three initial groups: 67 received a 150 mg dose of AIN457 (also known as secukinumab), 66 received a 300 mg dose, and 65 received a placebo (a dummy treatment with no active ingredient). The trial ran in two main treatment phases over about two and a half years, plus a short follow-up period. It was measuring changes in nail psoriasis severity using a scoring tool called the NAPSI — a scale from 0 to 80 where a lower score means less nail involvement — as well as broader skin disease scores. The reported data shows that after 16 weeks, the average NAPSI score had decreased (meaning nail condition had changed) by approximately 38% in the 150 mg group, 46% in the 300 mg group, and 12% in the placebo group. By the end of the longer treatment phase (around week 132), the reported reductions in NAPSI scores were approximately 53% for the ongoing 150 mg group, 71% for the 300 mg group, 63% for participants who had switched from placebo to 150 mg, and 73% for those who had switched from placebo to 300 mg. For broader skin disease measures (PASI75 and IGA scores, which assess overall skin involvement and severity), the reported data shows that at various points up to week 132, between roughly 52% and 87% of participants in the two secukinumab groups met the response thresholds being tracked, depending on the time point measured. Regarding immunogenicity — meaning whether the body developed antibodies against the study drug — the reported data shows small numbers of participants tested positive across all groups: 2 in the 150 mg group, 5 in the 300 mg group, 4 in the placebo-to-150 mg group, and 3 in the placebo-to-300 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01806597 · results posted 22 February 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01806597) looked at a medicine called AIN457 (also known as secukinumab) in people with a skin condition affecting the palms of the hands and soles of the feet (palmoplantar psoriasis). The trial had two main treatment periods and a short follow-up phase. In the first period (up to 16 weeks), 68 people received AIN457 at a 150 mg dose, 69 received it at a 300 mg dose, and 68 received a placebo (a dummy treatment with no active ingredient). Participants were then followed for an extended period out to around 132 weeks, during which some people originally on placebo were switched to one of the AIN457 doses. The main thing the trial measured was how many participants achieved a score of "clear" or "almost clear" skin on a standardised rating scale (called the ppIGA) after 16 weeks, where they also had to have improved by at least 2 points from their starting score. The reported data shows that at 16 weeks, 22% of those on the 150 mg dose and 33.3% of those on the 300 mg dose met this measure, compared with 1.5% of those on placebo. The trial also tracked this same skin-score measure at various later time points, and reported a separate score (called ppPASI, a 0–72 scale where higher numbers mean more severe disease) to capture changes in the area and severity of skin affected. The reported data shows that by week 16, the average ppPASI score had dropped by about 9.7 points in the 150 mg group and about 11.3 points in the 300 mg group, compared with a drop of about 3.2 points in the placebo group. Later time-point data was also reported, but some measurements in the later periods were not fully reported for all sub-groups in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
-
NCT00716144 · results posted 29 January 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 176 people with plaque psoriasis across four groups: 41 received a placebo (a dummy treatment with no active ingredient), and 45 each received one of three different daily doses of a medicine called R115866 (0.5 mg, 1.0 mg, or 2.0 mg). Not everyone finished the trial — 32 placebo participants, 38 in the 0.5 mg group, and 33 each in the 1.0 mg and 2.0 mg groups completed it. The trial's main focus was on measuring skin improvement using a scoring system called the PASI (Psoriasis Area and Severity Index), which rates how much of the body is affected by psoriasis and how severe it looks, on a scale from 0 (clear) to 72 (most severe). The primary goal was to count how many participants saw their PASI score drop by at least 75% by a set mid-point visit (Visit 6). The reported data shows that, at Visit 6, 4 out of 41 placebo participants, 7 out of 45 in the 0.5 mg group, 4 out of 45 in the 1.0 mg group, and 5 out of 45 in the 2.0 mg group reached that 75% improvement mark. For the secondary measures — which tracked skin scores at several other time points — the reported numbers were similarly modest across all groups at earlier visits, with slightly more participants reaching the 50% improvement threshold and the 75% threshold at a later visit (Visit 8): for example, at that later visit, 7 placebo, 9 in the 0.5 mg, 8 in the 1.0 mg, and 11 in the 2.0 mg group reached the 50% improvement mark. A separate overall skin rating by the treating doctor (the IGA scale, from 0 = clear to 4 = severe) also showed that by the later visit, 8 placebo, 7 in the 0.5 mg, 12 in the 1.0 mg, and 15 in the 2.0 mg participants were rated in the clearer categories, though earlier visits showed zero participants in those categories across all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02207244 · results posted 6 November 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02207244) enrolled 992 adults with psoriasis across its first phase, split into three groups: 248 received a placebo (an inactive treatment), 496 received guselkumab (100 mg), and 248 received adalimumab (an existing treatment). The trial ran in several stages over a number of years, with some participants switching treatments or continuing into longer follow-up phases. The trial was primarily measuring skin improvement at 16 weeks, using two scoring tools: the Investigator's Global Assessment (IGA), where a doctor rates how clear the skin looks on a scale from 0 (fully cleared) to 4 (severe); and the PASI 90, which measures whether a participant's psoriasis severity score improved by at least 90% from where it started. The reported data shows that at 16 weeks, 84.1% of participants in the guselkumab group reached an IGA score of 0 or 1 (cleared or nearly cleared), compared with 8.5% in the placebo group. For the PASI 90 measure at 16 weeks, 70.0% of the guselkumab group met that threshold, compared with 2.4% in the placebo group. The reported data also shows secondary results comparing guselkumab and adalimumab at 24 weeks: 83.5% of the guselkumab group reached an IGA score of 0 or 1, compared with 64.9% for adalimumab; and 75.2% of the guselkumab group reached PASI 90, compared with 54.8% for adalimumab. A further secondary measure reported that 51.8% of the guselkumab group achieved fully cleared skin (IGA score of 0) at week 24, versus 31.5% in the adalimumab group. The reported data also includes a longer-term result looking at whether participants who had responded well to guselkumab could maintain that improvement after treatment was stopped. Among those whose treatment was withdrawn, 35.4% maintained a PASI 90 response through to week 48, compared with 81.8% of those who continued on guselkumab. Data for any outcomes not listed here were not reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02474082 · results posted 27 October 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02474082) enrolled 105 people in the secukinumab group and 97 people in the fumaric acid group, for a total of 202 participants. The trial was measuring changes in psoriasis severity over 24 weeks using a scoring system called the PASI (Psoriasis Area and Severity Index), which rates the extent and appearance of psoriasis on the skin on a scale from 0 (no signs) to 72 (most severe). The main question the trial was designed to answer was what proportion of participants in each group achieved at least a 75% reduction in their PASI score by week 24 — a commonly used benchmark in psoriasis research. It is worth noting that far more participants in the fumaric acid group did not complete the study (54 out of 97) compared to the secukinumab group (6 out of 105). The reported data shows that by week 24, approximately 89.5% of participants in the secukinumab group and approximately 33.7% of participants in the fumaric acid group had reached that 75% reduction threshold. The secondary outcome data shows how these figures changed week by week. For example, the proportion reaching at least a 50% reduction in PASI score by week 8 was reported as 96.2% for secukinumab and 41.1% for fumaric acid. For an even higher threshold — a 90% reduction in PASI score — the reported figures at week 24 were 46.7% for secukinumab and 1.1% for fumaric acid. Complete clearance of psoriasis (a PASI score of zero) by week 24 was reported for 15.2% of the secukinumab group and 0% of the fumaric acid group. The reported data for body surface area affected by psoriasis showed a decrease over time in both groups, with the secukinumab group starting at around 23.8% of body surface area affected and reaching approximately 7.6% by week 8, while the fumaric acid group started at around 23.2% and reached approximately 17.8% by the same point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02207231 · results posted 19 October 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02207231) enrolled 837 adults with psoriasis across three treatment groups: 174 received a placebo before switching to guselkumab, 329 received guselkumab from the start, and 334 received adalimumab (another existing treatment) before switching to guselkumab. The trial was measuring how participants' skin cleared over time using two main scoring tools — one where a doctor rates the overall skin condition on a scale from 0 (clear) to 4 (severe), and another that scores the extent and severity of psoriasis patches across the body on a scale from 0 to 72. The study ran in stages over several years, with the final open-label phase continuing to week 264. The reported data shows that at week 16, 85.1% of participants in the guselkumab group reached a doctor-rated score of "cleared" or "minimal", compared with 6.9% in the placebo group. On the body-coverage scoring tool, 73.3% of the guselkumab group achieved at least a 90% improvement from their starting score, compared with 2.9% in the placebo group. When guselkumab was compared against adalimumab at weeks 24 and 48, the reported results showed higher percentages of participants in the guselkumab group reaching "cleared" or "minimal" skin ratings (84.2% and 80.5%, respectively) than in the adalimumab group (61.7% and 55.4%). Similar patterns were seen for the 90% body-coverage improvement measure at those same time points. The reported data also includes a quality-of-life questionnaire scored from 0 (no impact) to 30 (very large impact on daily life). At week 16, the guselkumab group's average score changed by −11.2 points from the start, while the placebo group's average changed by −0.6 points — meaning participants in the guselkumab group reported a larger reduction in the questionnaire score. These numbers describe what was recorded in the trial; they do not tell us how any individual person might respond. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01401452 · results posted 4 October 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 246 adults who had psoriasis along with at least one other health condition at the same time (such as diabetes, heart disease, or arthritis). The study tracked participants over nine months, with check-ins at one, three, six, and nine months. Of the 246 who started, 174 completed the full study. The trial was measuring changes in the severity of psoriasis skin symptoms, as well as how much psoriasis was affecting participants' daily lives and overall quality of life. The reported data shows that the main thing being measured was the proportion of participants whose psoriasis skin score (called the PASI score, a 0–72 scale where higher means more severe) dropped by 75% or more from where it started. According to the results reported on ClinicalTrials.gov, that figure was 31.3% of participants at one month, rising to 52.8% at three months, 55.8% at six months, and 57.5% at nine months. The reported data also shows results for other PASI thresholds: a 50% or greater improvement was reported in 51.0%, 66.8%, 66.9%, and 72.5% of participants at those same time points; a 90% or greater improvement was reported in 11.5%, 38.9%, 45.5%, and 43.7%; and complete clearing of skin symptoms (100% improvement) was reported in 6.3%, 22.3%, 32.5%, and 30.4% of participants respectively. The reported data shows that a quality-of-life questionnaire about how psoriasis affected everyday life (scored 0–30, where higher means a greater impact) had a mean starting score of 12.4, which fell to 7.2 at one month, 5.4 at three months, 4.8 at six months, and 4.3 at nine months. A separate general health questionnaire (scored 0–100 for physical wellbeing, where higher is better) had a mean starting score of 46.33, rising to 48.19 at one month, 49.54 at three months, 49.31 at six months, and 50.48 at nine months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01882439 · results posted 15 September 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01882439) enrolled 394 adults in total across four groups. Two groups received the medicine tofacitinib — either 5 mg or 10 mg twice daily — from the start of the study (131 and 132 people respectively). Two smaller groups (66 and 65 people) started on a placebo (a dummy treatment with no active ingredient) and were later switched to one of the two tofacitinib doses. The trial was measuring how people with rheumatoid arthritis responded over time, using two main yardsticks: a standard joint-improvement scoring system called ACR20 (which looks at whether tender and swollen joint counts and several other measures improved by at least 20%), and a daily-living difficulty questionnaire called the HAQ-DI (scored from 0, meaning no difficulty, to 3, meaning extreme difficulty). The reported data shows that at the three-month mark — the main measurement point — about 49.6% of participants in the 5 mg tofacitinib group and about 47.0% in the 10 mg group met the ACR20 improvement threshold, compared with about 23.7% of participants in the placebo group. For the daily-living difficulty questionnaire (HAQ-DI), the reported average change from the starting score was −0.39 points for the 5 mg group and −0.35 points for the 10 mg group, versus −0.14 points for the placebo group (a negative number means scores moved toward less difficulty). The reported data also shows figures at earlier and later time points for stricter improvement thresholds (ACR50 and ACR70), with the percentage of participants meeting those higher bars being smaller across all groups; complete data for all time points and all groups was not reported for some of the secondary measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01483599 · results posted 2 August 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 293 adults with psoriasis across seven groups during the first phase (up to Week 16). Participants were randomly assigned to receive one of five doses of an investigational medicine called CNTO1959 (guselkumab), a placebo (a dummy treatment with no active ingredient), or an existing medicine called adalimumab. The trial was primarily measuring how many participants had their skin largely or completely cleared by a doctor's assessment at Week 16, and then continued to track participants through to Week 40. The reported data shows that at Week 16, 7.1% of participants in the placebo group had their skin rated as "cleared" or "minimal" by the treating doctor, compared with 34.1%, 61.0%, 78.6%, 85.7%, and 83.3% in the five increasing CNTO1959 dose groups respectively, and 58.1% in the adalimumab group. A separate skin-coverage score (called PASI 75 — meaning at least a 75% reduction in the area and severity of psoriasis patches compared to the start) showed similar patterns: 4.8% in the placebo group, ranging from 43.9% to 81.0% across the CNTO1959 dose groups, and 69.8% in the adalimumab group. At Week 40, the doctor's "cleared or minimal" ratings in the CNTO1959 groups ranged from 35.3% to 81.1%, and 48.6% in the adalimumab group. A quality-of-life questionnaire (scored 0–30, where higher means greater impact on daily life) showed average reductions from baseline ranging from −2.3 points in the placebo group to around −10 to −11 points across the CNTO1959 and adalimumab groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01107457 · results posted 25 July 2017
According to the results reported on ClinicalTrials.gov, this trial tested four different doses of a medicine called ixekizumab (10 mg, 25 mg, 75 mg, and 150 mg) against a placebo (a dummy treatment with no active ingredient) in people with psoriasis. In Part A of the trial, 142 people were enrolled across the five groups — 27 in the placebo group, and between 28 and 30 in each of the four dose groups. A second phase (Parts B and C) involved 120 participants receiving ixekizumab, of whom 74 completed the longer follow-up period. The trial primarily measured changes in psoriasis severity using a scoring system called PASI (Psoriasis Area and Severity Index), which rates the extent and severity of skin involvement on a scale from 0 to 72. The reported data shows that at 12 weeks, 7.7% of participants in the placebo group achieved a 75% or greater improvement in their PASI score, compared with 28.6% in the 10 mg group, 76.7% in the 25 mg group, 82.8% in the 75 mg group, and 82.1% in the 150 mg group. For average overall PASI improvement, the placebo group showed a 16.2% improvement, while the four ixekizumab dose groups showed improvements of 49.3%, 78.5%, 85.7%, and 87.1% respectively. A secondary measure — a doctor's global rating of skin clearance — showed that 7.7% of placebo participants reached a "clear" or "minimal" rating, compared with 25.0%, 70.0%, 72.4%, and 71.4% across the four ixekizumab dose groups. The reported data also shows that the number of participants who experienced treatment-emergent adverse events (health problems that appeared or worsened after starting treatment) over 20 weeks was 17 in the placebo group, 21 in both the 10 mg and 25 mg groups, 17 in the 75 mg group, and 13 in the 150 mg group. Small reductions in self-reported anxiety, depression, and depressive symptom scores were recorded across all groups at week 16, with the ixekizumab groups generally showing slightly larger reductions than the placebo group; however, all changes were modest in size on the scales used. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02074982 · results posted 21 July 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 337 people in the AIN457 300 mg group (also known as secukinumab) and 339 people in the ustekinumab group — a total of 676 participants — all of whom had moderate to severe plaque psoriasis. The trial was measuring skin improvement using a scoring system called the Psoriasis Area and Severity Index, or PASI. This is a scale from 0 (no disease) to 72 (most severe disease) that takes into account how much of the body is affected and how red, thick, or flaky the skin is. The trial tracked what proportion of people in each group achieved at least a 90% improvement in their PASI score (called "PASI 90") at 16 weeks and again at 52 weeks, as well as how quickly improvement appeared by week 4. The reported data shows that at week 16 (the main measuring point), 79.0% of participants in the AIN457 group and 57.3% of participants in the ustekinumab group were recorded as reaching the PASI 90 threshold. For the early speed-of-response measure at week 4, the reported data shows that 49.7% of the AIN457 group and 20.6% of the ustekinumab group had reached at least a 75% improvement in their PASI score at that earlier time point. At the one-year mark (week 52), the reported figures were 74.9% for the AIN457 group and 60.6% for the ustekinumab group reaching the PASI 90 threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02203032 · results posted 17 July 2017
According to the results reported on ClinicalTrials.gov, this trial involved 872 people who all started on a medicine called ustekinumab for the first 16 weeks. After that, those whose skin had not cleared enough were randomly split into two groups for a further blinded phase (meaning neither the participants nor the doctors knew who was getting which treatment): 135 people received guselkumab, and 133 received ustekinumab. A further 585 people whose skin had responded well enough continued on ustekinumab in a separate, non-randomised group. The trial was measuring how well each medicine controlled psoriasis — a skin condition causing red, scaly patches — using two scoring systems: the IGA (a doctor's overall rating of skin from 0 = clear to 4 = severe) and the PASI (a detailed score from 0 to 72, where higher means worse). The reported data shows the following numbers for the randomised groups. For the primary measure — how many check-up visits (out of a possible three, between weeks 28 and 40) each participant achieved a good IGA response (rated 0 or 1, with at least a 2-grade improvement from week 16) — the guselkumab group averaged 1.5 visits and the ustekinumab group averaged 0.7 visits. For the secondary measures over the same period: the average number of visits where participants achieved a PASI 90 response (at least 90% improvement in skin severity score) was 2.2 for guselkumab and 1.1 for ustekinumab; the average number of visits where participants' skin was rated completely clear (IGA score of 0) was 0.9 for guselkumab and 0.4 for ustekinumab. At the week 28 check-in specifically, the reported data shows that 31.1% of participants in the guselkumab group and 14.3% in the ustekinumab group achieved an IGA score of 0 or 1 with at least a 2-grade improvement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02559622 · results posted 13 July 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 151 people in total across four groups. Participants received either secukinumab (a medicine) at one of two doses — 300 mg or 150 mg — or a placebo (a dummy treatment with no active medicine) for an initial period, with those on placebo later switching to one of the two secukinumab doses. The trial was measuring how blood vessels were functioning in people with psoriasis, using several non-invasive tests: one called Flow Mediated Dilation (FMD), which looks at how well the inner lining of blood vessels expands; another measuring arterial stiffness (how rigid the vessel walls are); and MRI scans to look at the thickness of artery walls. Most participants completed the study — 140 out of 151. The reported data shows that for the main (primary) outcome at week 12, the FMD reading — expressed as a percentage increase in the width of an artery — was 5.23% in the secukinumab 300 mg group and 3.65% in the pooled placebo group. For the secondary outcomes, the reported changes in FMD from the start of the study were small and varied across the different groups and time points (weeks 4, 12, and 52), with figures ranging from around −0.9% to +1.4%. Similarly, the measures of arterial stiffness (the Aortic Augmentation Index and Pulse Wave Velocity) showed only small numerical differences across all groups and time points. The reported data shows that MRI measurements of artery wall area — used to estimate plaque build-up — also varied across groups and time points, with changes ranging from approximately −15 mm² to +16 mm² depending on the group and vessel being measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01707043 · results posted 11 July 2017
According to the results reported on ClinicalTrials.gov, this trial involved 20 adults in total, split into two groups of 10. It was a crossover study, meaning each participant tried both products — one called Taclonex Scalp Suspension and one called Taclonex Ointment — but in different orders. The trial was measuring how participants felt about using each product, based on their personal preferences rather than any clinical or medical outcome. The reported data shows that preference was measured using a 15-question survey, where participants rated things like how the product felt on the skin, how greasy it was, and how long it took to apply. Each question was scored from 1 (extremely unpleasant) to 7 (extremely appealing), giving a possible total score anywhere between 15 and 105, with higher scores indicating a more positive experience. In the first treatment session, the group who used the scalp suspension first reported an average total score of 81.1, while the group who used the ointment first reported an average score of 77.6. In the second treatment session, those same groups (now having swapped products) reported average scores of 78.9 and 69.4 respectively. The reported data covers only how participants described their personal experience of using the products — things like texture and ease of application. No data on medical outcomes such as skin changes or symptom relief was reported as part of these results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02192164 · results posted 28 June 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 126 people with psoriasis, all of whom received the medicine etanercept. Of those, 112 completed the study. Participants were divided into two groups for comparison — non-smokers (which included people who had never smoked and former smokers) and current smokers. The trial used a scoring system called PASI (Psoriasis Area and Severity Index) to measure the severity of psoriasis on a scale from 0 (no disease) to 72 (most severe). The main thing being measured was how much that score changed after 24 weeks of treatment. The reported data shows that at the start of the study, the average PASI score was around 21.0 for non-smokers and 20.4 for smokers — indicating similar levels of psoriasis severity between the two groups. By week 24, the non-smoker group's average score had fallen by about 18.4 points, while the smoker group's average score had fallen by about 15.6 points. At week 12, the reported drops were approximately 18.2 points for non-smokers and 17.3 points for smokers. A separate measure looked at the proportion of participants whose PASI score dropped by at least 75% (known as a "PASI75 response"). The reported data shows that at week 24, approximately 86% of non-smokers and 69% of smokers reached this threshold; at week 12, the figures were approximately 83% and 77% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01163253 · results posted 26 June 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01163253) enrolled 2,281 participants who received tofacitinib at a 10 mg dose, and a separate group of 586 participants who received either a 5 mg or 10 mg dose. The trial was primarily measuring safety-related outcomes — specifically, how many participants experienced unwanted medical events (called adverse events), how severe those events were, whether any serious medical events occurred, and whether there were any notable changes in blood test results over time. The study followed participants for up to approximately 67 months (just over five and a half years). The reported data shows that, in the 10 mg group, 1,876 out of 2,281 participants experienced at least one adverse event, and 304 experienced a serious adverse event (such as hospitalisation or a life-threatening event). In the 5 mg or 10 mg group, 490 out of 586 participants had at least one adverse event, and 88 had a serious adverse event. When looking at how severe the adverse events were across the 10 mg group, 5,354 were recorded as mild, 3,268 as moderate, and 410 as severe (noting these are counts of events, not individual people). The reported data also shows that 2,203 participants in the 10 mg group and 565 in the 5 mg or 10 mg group had at least one abnormal laboratory (blood or urine) test result during the study. Regarding blood haemoglobin levels (a measure of red blood cells carrying oxygen), the reported data shows that both groups started with an average level of 14.64 g/dL. Small average decreases were recorded at one month (−0.24 in the 10 mg group; −0.32 in the other group), at three months (−0.27 and −0.39 respectively), and at six months (−0.27 and −0.30 respectively). The data reported does not include outcome figures beyond six months for this particular measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02425826 · results posted 6 June 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02425826) looked at a medicine called apremilast for people with psoriasis — a skin condition causing red, scaly patches. A total of 148 people were assigned to receive apremilast and 73 received a placebo (a dummy treatment with no active ingredient) during the first 16 weeks. After that, participants who had been on the placebo were switched to apremilast for a further extension phase running to week 52. The trial measured changes in skin coverage and severity, quality of life, itching, and how doctors and patients rated overall disease severity. The reported data shows that, after 16 weeks, participants in the apremilast group had an average reduction of about 48% in a combined score measuring how much skin was affected and how severe the patches were, compared with about 10% in the placebo group. On a quality-of-life questionnaire scored from 0 (best) to 30 (worst), the apremilast group reported an average improvement of 4.8 points versus 2.4 points in the placebo group. For itching — measured on a 0–100 scale — the reported data shows a reduction of around 14 to 19 points in the apremilast group compared with around 10 points in the placebo group, depending on the time point measured. The reported data also shows that around 30% of participants in the apremilast group had their skin rated as "clear" or "almost clear" by a doctor at week 16, compared with about 10% in the placebo group. When participants rated their own skin, roughly 34% in the apremilast group rated it as "clear" or "very mild" versus about 21% in the placebo group. Among those who had scalp psoriasis at the start, about 50% in the apremilast group were rated as having "clear" or "minimal" scalp involvement at week 16, compared with about 38% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02181790 · results posted 2 May 2017
According to the results reported on ClinicalTrials.gov, this trial was set up to look at the use of excimer laser treatment for psoriasis affecting the palms and soles of the feet. The study was designed to include two groups: one group receiving laser treatment on one palm or sole, and another receiving treatment on both palms and soles. The trial aimed to measure two things — how much the psoriasis improved (using a scoring tool called the Psoriasis Area and Severity Index, or PASI, which rates the extent and appearance of psoriasis on the skin), and how much participants' day-to-day quality of life changed (using a tool called the Dermatology Life Quality Index, or DLQI, which captures how a skin condition affects daily activities). The reported data shows that only 2 people were enrolled in the trial, both placed in the first group (one palm/sole). No participants were enrolled in the second group. Neither of the 2 participants who started the study completed it, and no outcome measurement data — meaning no PASI scores and no quality-of-life scores — were reported for either group. In other words, the trial did not produce any results for its main measurements. Because so few participants joined and none completed the study, the questions this trial set out to answer were not able to be addressed based on the information submitted. The reported data shows no findings about the laser treatment's effect on psoriasis scores or quality of life. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02518048 · results posted 21 April 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02518048) enrolled 35 participants, with 34 completing the study and 1 not completing it. The trial compared two treatments for a skin condition — LEO 90100 Aerosol Foam and Betesil® 2.25 mg medicated plaster — applied to separate test sites on the same person. Researchers measured the severity of three skin signs (redness, scaling, and skin thickening/infiltration) using a scoring system that ran from 0 (no sign present) to 3 (severe), with the three scores added together to give a Total Clinical Score (TCS) ranging from 0 to 9. Skin thickness was also measured using ultrasound. The reported data shows that at the start of the trial, both treatment sites had the same average Total Clinical Score of 6.6 out of a possible 9. By the end of treatment (day 29), the reported average score had dropped by 5.8 points for the LEO 90100 Aerosol Foam sites and by 3.6 points for the Betesil® 2.25 mg sites. For the individual signs, the reported data shows that redness, scaling, and infiltration each decreased across both treatment sites over time, with the reductions appearing larger at the LEO 90100 Aerosol Foam sites at every measurement point. For example, by the final visit, the reported change in redness was -1.7 for LEO 90100 and -1.1 for Betesil®. The reported ultrasound measurements showed that total skin thickness decreased by an average of 1.0 mm for LEO 90100 and 0.6 mm for Betesil®, while the echo-poor band (a layer under the skin surface) decreased by 1.3 mm and 0.7 mm respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01937260 · results posted 10 April 2017
According to the results reported on ClinicalTrials.gov, this trial involved 31 participants split into two groups: 21 people in Cohort 1 and 10 people in Cohort 2. The trial was measuring how a drug called brodalumab affects the way the body processes another drug called midazolam — specifically, how much midazolam gets into the bloodstream and how long it stays there. This type of measurement is known as a "pharmacokinetic" study, meaning it tracks how a drug moves through the body over time. Almost all participants finished the study — 20 out of 21 in Cohort 1 and all 10 in Cohort 2. The reported data shows three main measurements, all from Cohort 1 only (no figures were reported for Cohort 2). The first was the highest level of midazolam detected in the blood at any single point, which was reported as 11.5 nanograms per millilitre (a very small unit of concentration). The second measurement tracked the total amount of midazolam in the bloodstream over the entire time it was present, reported as 41.5 hr\*ng/mL (this figure combines concentration and time, giving a picture of overall exposure). The third was a similar "total exposure" figure, but only counted up until the last point where midazolam could still be detected, and that was reported as 39 hr\*ng/mL. These numbers reflect what was observed after participants received a single dose of midazolam before and after receiving brodalumab. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02186665 · results posted 31 March 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02186665) involved 19 people in total — 8 who were assigned to receive calcitriol ointment and 11 who were assigned to receive a placebo (an inactive comparison treatment). All 8 participants in the calcitriol group completed the trial, while 10 out of 11 in the placebo group completed it. The trial was measuring a skin condition called psoriasis, and the main thing being tracked was how participants' skin appearance was rated by a clinician using a scoring system called the Investigator's Global Assessment (IGA) — a scale from 0 (clear skin) to 4 (severe). The goal was to see how many people improved by at least 2 points on that scale and reached a score of 0 or 1 by week 8. The reported data shows that, at the 8-week mark, 3 out of 8 participants in the calcitriol ointment group met this improvement target. In the placebo group, 7 out of 10 participants who completed the trial met the same target. No secondary outcome measures were included in the data submitted to ClinicalTrials.gov, so no further results are available to describe. It is worth noting that this was a very small trial, and the numbers reported here reflect only the participants involved in this specific study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01766440 · results posted 31 March 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 18 participants who used a calcitriol 3 mcg/g ointment. Seventeen participants completed the study, and one did not finish. The trial was measuring how much of the active ingredient (calcitriol) got into the bloodstream after the ointment was applied to the skin — this type of testing is known as a pharmacokinetic (PK) study, meaning it tracks how a substance moves through the body over time. The reported data shows several blood-level measurements taken after 14 days of use. The highest level of calcitriol detected in the blood (called the peak concentration) was reported as 120.7 pg/mL (picograms per millilitre — a very small unit of measurement). The lowest level recorded at that same time point was 92.6 pg/mL. The time at which the peak level was reached was reported as approximately 1.46 hours after applying the ointment. The trial also measured the total amount of calcitriol in the blood over different time windows: over 6 hours it was reported as 650.3 pg\*h/mL, over 9 hours as 952.6 pg\*h/mL, and over 12 hours as 1,268.9 pg\*h/mL. These figures represent the area under the curve — essentially a way of capturing the overall exposure to the substance across a set period of time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01967069 · results posted 13 March 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 277 participants in total — 182 people received a spray called DFD01, and 95 people received a "vehicle spray," which is an inactive spray used as a comparison (sometimes called a placebo). The trial was measuring whether participants' skin condition was rated by a doctor as "clear" or "almost clear" using a standardised scoring tool called the Investigator's Global Assessment (IGA). Eight participants in each group did not complete the trial. The reported data shows that the main result — known as the primary outcome — looked at what percentage of participants in each group were rated as "clear" or "almost clear" by their doctor at the end of the study. According to the results reported on ClinicalTrials.gov, 21.5% of participants in the DFD01 spray group reached this rating, compared with 7.4% of participants in the vehicle (inactive) spray group. No other outcome measures were included in the submitted results data, so further detail beyond these figures was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01970488 · results posted 13 December 2016
According to the results reported on ClinicalTrials.gov, this trial involved adults with psoriasis and was conducted in two parts. In Part 1, 175 participants were assigned to receive ABP 501 (a medicine being compared to an existing treatment) and 175 were assigned to receive adalimumab (the existing, approved treatment), running for 16 weeks. In Part 2, participants continued into a longer follow-up phase through to around week 50, where some stayed on the same medicine they started with, and one group switched from adalimumab to ABP 501. The trial was measuring changes in psoriasis severity using a scoring system called the PASI (Psoriasis Area and Severity Index), which rates the redness, thickness, and scaliness of skin patches on a scale from 0 to 72 — with higher numbers meaning more severe psoriasis. The reported data shows that by week 16, participants in the ABP 501 group had, on average, an approximately 81% improvement in their PASI score from where they started, while the adalimumab group had an approximately 83% improvement. When looking at the proportion of people whose PASI score improved by 75% or more — a commonly used marker in psoriasis research — the reported data shows around 74% of the ABP 501 group and around 83% of the adalimumab group reached that level by week 16. By week 32, the reported figures for that same marker were approximately 83%, 85%, and 85% across the three continuing groups respectively, and by week 50 they were approximately 85%, 87%, and 81%. The reported data shows that these figures remained broadly similar across all three groups through weeks 32 and 50, including the group that switched from adalimumab to ABP 501 partway through. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01597245 · results posted 20 October 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01597245) enrolled 1,224 participants across its initial induction phase, which ran for the first 12 weeks. Participants had moderate to severe chronic plaque psoriasis and were randomly assigned to receive either a placebo (an inactive injection), a comparison medicine called etanercept (50 mg), or one of two dosing schedules of the medicine being studied — ixekizumab — given either every two weeks or every four weeks. The trial then continued through a maintenance phase (up to week 60) and a long-term extension phase (up to around week 264, or about five years), with participants re-grouped based on how they had responded earlier in the trial. The reported data shows the following results at week 12 for two key measures. The first measure was a doctor's overall rating of skin clearance (called the sPGA), where a score of 0 or 1 meant the skin was clear or nearly clear. According to the results reported on ClinicalTrials.gov, 2.4% of placebo participants reached that level, compared with 36.0% in the etanercept group, 72.9% in the ixekizumab every-four-weeks group, and 83.2% in the ixekizumab every-two-weeks group. The second measure tracked the proportion of participants whose psoriasis skin score (called PASI) improved by at least 75% from the start of the trial. The reported data shows 2.4% achieved this in the placebo group, 41.6% in the etanercept group, with figures for the ixekizumab groups not fully available in the data provided to us — those specific numbers were not reported in the portion of data available for this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01947491 · results posted 6 October 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 394 people across four groups. Participants were assigned to one of two test treatments — a spray called DFD01 or a lotion called Comp01 — or to a matching "vehicle" (an inactive version of each product containing no active ingredient). The trial was measuring skin condition outcomes using a scale called the Investigator Global Assessment, or IGA, where a trained assessor rated each participant's skin. The main thing being measured was how many people in each group reached a rating of "clear" or "almost clear" by the end of the study. The reported data shows that results were only published for two of the four groups for the primary outcome. In the DFD01 Spray group (174 people started, 166 completed), 19.0% of participants were rated as "clear or almost clear" by the assessor. In the Vehicle Spray group (87 started, 81 completed), 2.3% of participants received that same rating. No figures were reported on ClinicalTrials.gov for the Comp01 Lotion group or its matching vehicle group for this outcome measure, so those results cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01761019 · results posted 21 September 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 8 participants, all of whom completed the study without dropping out. All 8 participants were treated with a product called Taclonex Topical Suspension, a medicated skin treatment for psoriasis. The trial was measuring changes in psoriasis severity over 12 weeks, looking at things like how a study doctor rated the condition, how much of the body was affected, and how satisfied participants were with their treatment. The reported data shows that the study doctor's severity rating (scored on a scale of 0 to 5, where 5 is most severe) changed by an average of 1.13 points from the start of the study to week 12. The reported data also shows that the average percentage of body surface area affected by psoriasis changed by 0.7 percentage points over the same period. On a patient satisfaction scale — where 4 meant "very satisfied" and 1 meant "very disappointed" — the average score reported at week 12 was 3.63 out of 4. For the question of whether participants wanted to switch to a different type of treatment, the reported figure was 0%, meaning none of the participants indicated a desire to change at week 12. Regarding safety, the reported data shows that 1 adverse event (an unwanted or unexpected health occurrence noted during the study) was recorded, though further detail about its nature was not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02054481 · results posted 19 September 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 166 adults with psoriasis (a skin condition) across four groups. Participants received one of three doses of an investigational medicine called BI 655066 (18 mg, 90 mg, or 180 mg), or a comparator medicine called Stelara (ustekinumab). The trial's main goal was to measure how many people in each group had their psoriasis severity score — called a PASI score, where lower is better — reduced by at least 90% by week 12. Most participants completed the study, with between 39 and 40 out of each group of roughly 40–43 finishing. The reported data shows that at week 12, the proportion of participants who reached that 90% or greater reduction in their PASI score was 32.6% in the 18 mg group, 73.2% in the 90 mg group, 81.0% in the 180 mg group, and 40.0% in the Stelara group. For the secondary measures, the reported data shows that at week 12, the share of participants who achieved at least a 75% reduction in their PASI score was 67.4% (18 mg), 97.6% (90 mg), 90.5% (180 mg), and 77.5% (Stelara). A complete clearance of psoriasis (100% reduction in PASI score) at week 12 was reported in 14.0%, 41.5%, 50.0%, and 17.5% of participants respectively. At week 24, the 90% reduction milestone was reported for 30.2%, 65.9%, 85.7%, and 55.0% of participants across the same four groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01600222 · results posted 16 September 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01600222) enrolled 37 people who used a treatment called LEO 90100, with 35 completing the study and 2 not finishing. The trial was measuring two main things: whether LEO 90100 had any effect on the body's stress hormone system (called the HPA axis, which involves a gland called the adrenal gland that produces cortisol, a hormone important for the body's response to stress), and whether it affected calcium levels in the body — both in the blood and in urine. The reported data shows that when participants underwent a hormone challenge test at Day 28 — where a substance is injected to stimulate cortisol production and the response is measured — none of the 37 participants (0 out of 37) had a cortisol level at or below the threshold (18 mcg/dL) that would indicate a concern with adrenal gland function. Regarding calcium, the reported data shows a very small average increase in blood calcium levels (0.014 mmol/L), a small average decrease in the amount of calcium passed in urine over 24 hours (−0.49 mmol/24H), and a small average decrease in the ratio of calcium to creatinine in urine (−0.030 mmol/g) from the start of the study to Day 28. These are average changes across the group and the data does not include a comparison group. For the secondary outcomes, the reported data shows that again 0 participants had a low cortisol response at either 30 or 60 minutes after the hormone challenge test, and 1 participant was reported as having an adverse drug reaction (an unwanted effect that the study doctor considered possibly related to the treatment). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01111123 · results posted 24 June 2016
According to the results reported on ClinicalTrials.gov, this trial looked at a two-stage treatment approach for what appears to be a skin condition (psoriasis). In the first, open-label stage — where everyone received the same treatment (a moisturising lotion called Lac-Hydrin combined with a steroid cream called Ultravate) — 55 people started and 41 completed it. Of those who responded well enough to move on, 41 participants entered the second (maintenance) stage and were split into two groups: 21 people continued with Lac-Hydrin plus Ultravate, and 20 received Lac-Hydrin plus a placebo (an inactive substitute). All 21 in the active group completed the maintenance phase, while 18 out of 20 in the placebo group completed it. The reported data shows that the main outcome measured was a doctor's overall impression of the skin condition, scored on a scale from 0 (clear) to 5 (very severe), known as a Physician Global Assessment. At the end of the maintenance phase, 12 out of 21 participants in the Lac-Hydrin plus Ultravate group scored in a category suggesting improvement (rated 0 or 1 — "clear" or "almost clear"), while none (0 out of 20) in the Lac-Hydrin plus placebo group received those scores. The remaining 9 participants in the active group and all 20 in the placebo group were assessed in higher (less improved) categories. A secondary measure looked at three specific signs of the skin condition — redness, skin thickening, and scaling — and the reported numbers were identical to those from the main outcome measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02193815 · results posted 9 June 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants, all of whom completed the study with no drop-outs. The trial was testing several topical (applied to the skin) treatments for psoriasis — including two investigational products called PF-06263276 (a solution) and tofacitinib (an ointment), along with a comparator treatment called Daivonex and corresponding "vehicle" (dummy/placebo) versions of each active treatment. The main thing being measured was the thickness of psoriatic skin patches, using a specialised ultrasound device, with measurements taken at the start of the study and again on Days 8 and 12. The reported data shows that at the start of the study (baseline), psoriatic skin thickness across the different treatment areas ranged from roughly 353 to 376 micrometres (a micrometre is one-thousandth of a millimetre). By Day 12, the reported change from baseline in skin thickness was: PF-06263276 4% solution, +17.7 micrometres; its vehicle (placebo), +32.9 micrometres; tofacitinib 2% ointment, −117.8 micrometres; its vehicle (placebo), +0.1 micrometres; and Daivonex solution, −135.5 micrometres. Similar patterns were seen at Day 8. A separate measure — the area under the curve, which tracks skin thickness across the whole treatment period — was also reported for each treatment group, with values ranging from approximately 3,166 to 4,161 micrometre-days. For the Global Clinical Assessment (a doctor's visual rating scale from −1 "worsened" to 3 "completely healed"), the reported data shows that at Day 1 all 15 participants scored 0 (unchanged/baseline) across all treatment areas, and at Days 8 and 12 all 15 participants were assessed across each treatment group, though individual scores within the scale categories were not broken down further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01474512 · results posted 27 May 2016
According to the results reported on ClinicalTrials.gov, this trial tested a medicine called ixekizumab (also written as "Ixe") in people with moderate to severe plaque psoriasis — a skin condition causing red, scaly patches. The trial enrolled 1,296 participants across three starting groups: 431 received a dummy (placebo) injection, 432 received ixekizumab every four weeks, and 433 received it every two weeks. The trial ran in several stages — an initial treatment period, a longer maintenance period, a long-term extension, and a follow-up phase — measuring changes in skin condition using two main scoring tools: the sPGA (a doctor's overall rating of skin lesions on a 0–5 scale) and the PASI (a combined score of how much skin is affected and how severe the patches are). The reported data shows the following numbers at the end of the initial 12-week treatment period. For the first main measure — the proportion of participants whose doctor rated their skin as "clear" or "minimal" (a score of 0 or 1 on the sPGA scale, with at least a 2-point improvement) — the reported figures were: 3.2% of the placebo group, 76.4% of the every-four-weeks ixekizumab group, and 81.8% of the every-two-weeks ixekizumab group. For the second main measure — the proportion of participants whose overall skin score improved by at least 75% (known as PASI75) — the reported figures were: 3.9% of the placebo group, 82.6% of the every-four-weeks group, and 89.1% of the every-two-weeks group. The reported data also shows that the proportion of participants whose skin was rated completely clear (sPGA score of 0) was 0.0% in the placebo group, 34.5% in the every-four-weeks group, and a figure that was not fully reported in the data provided for the every-two-weeks group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00477191 · results posted 16 May 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 18 adults who had both psoriasis (a skin condition) and metabolic syndrome (a cluster of conditions including high blood pressure, high blood sugar, and excess body fat around the waist). All participants received the medication etanercept. The trial was measuring changes in several body markers over six months — primarily a protein in the blood called C-reactive protein (CRP), which can rise when there is inflammation in the body. Thirteen of the 18 participants completed the trial, and five did not finish. The reported data shows that the average change in CRP levels from the start of the trial to six months was 5.3 ng/mL (nanograms per millilitre, a unit of measurement for substances in the blood). For the secondary measures, the reported data shows an average change in blood sugar (plasma glucose) of 13 mg/dL over the same period. The trial also measured blood vessel function using something called the Reactive Hyperemia Index (RHI) — a score that reflects how well the lining of blood vessels is working, on a scale of 1 to 3, where a score below 1.67 is considered a sign of poorer vessel function. The reported average RHI score was 1.57. Additionally, the number of recorded side effects (adverse events) thought to be related to etanercept over the six months was reported as 6 events. It is worth noting that the data as submitted does not clarify whether these changes represent increases or decreases from the starting point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01610596 · results posted 11 April 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 72 adults in total — 36 people used a lotion containing halobetasol propionate 0.05% (an active ingredient), and 36 used a vehicle lotion (a lotion without the active ingredient, sometimes called a placebo). The trial was measuring the severity of psoriasis symptoms over 15 days, using a rating scale that ran from 0 (clear skin) to 4 (severe). Almost all participants finished the study; one person in the vehicle group did not complete it. The reported data shows that the main thing being measured was "overall disease severity" — whether a participant's skin reached a score of 0 or 1 (meaning clear or almost clear) by Day 15. According to the results reported on ClinicalTrials.gov, 30.6% of participants using the active lotion reached that score, compared with 0.0% of those using the vehicle lotion. For improvement — defined as the severity score dropping by at least two points from the starting point — the reported data shows 13.9% of the active lotion group reached this by Day 8, rising to 44.4% by Day 15, while 0.0% of the vehicle group reached this at either time point. The reported data also shows results for individual symptoms such as scaling, redness (erythema), raised skin patches (plaque elevation), and itching (pruritis), with the active lotion group generally showing higher percentages of participants reaching a score of 0 or 1 for each of those symptoms by Day 15 compared to the vehicle group. Changes in the percentage of body surface area affected were also measured, though the reported figures for the different time points were small in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01347255 · results posted 24 February 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 24 participants, all of whom completed the study with no dropouts. The trial was testing different formulations of a topical skin treatment — including a spray and ointment version called LEO 90100, a comparison ointment called Daivobet®, and vehicle (inactive) formulations — applied to separate areas of skin affected by psoriasis. Each participant's skin patches were assessed by a doctor who scored redness (erythema), flaking (scaling), and skin thickness/raised appearance (infiltration) over a period of about four weeks. The reported data shows that the main measure — the Total Clinical Score (TCS), which runs from 0 (no signs) to 9 (all signs severe) — changed from the starting point to the end of treatment as follows: the LEO 90100 spray/ointment group recorded a change of −6.00 points; the LEO 90100 formulation combined with a vehicle containing betamethasone (an active ingredient) recorded −4.96 points; the inactive vehicle-only formulation recorded −1.88 points; and the Daivobet® ointment recorded −5.25 points. A negative number means the score went down from the starting level. The reported data also shows reductions in individual sign scores (redness, flaking, and infiltration) and in skin thickness measured by ultrasound across all four treatment groups, with the vehicle-only group generally showing smaller reductions than the other groups. These numbers describe what was recorded and measured in this particular trial; they do not tell us how any individual person might respond, and the trial's design — where different treatments were applied to different patches on the same participants — means results should be interpreted with care. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01537432 · results posted 5 January 2016
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called AIN457 (secukinumab) at a dose of 300mg compared with a placebo (a dummy treatment with no active ingredient) in people with a skin condition. A total of 36 people took part — 24 received the active medicine and 12 received the placebo. The trial measured changes in skin tissue samples (biopsies) taken from affected areas of skin, looking at whether the tissue showed signs of improvement under a microscope. Eighteen of the 24 people in the medicine group and 10 of the 12 in the placebo group completed the study. The reported data shows that at 12 weeks, 56.5% of participants in the secukinumab group and 0% of participants in the placebo group met the criteria for what the researchers called "excellent improvement" in their skin tissue — meaning all four specific microscopic criteria for disease reversal were met at the same time. At 52 weeks, the reported data shows this figure rose to 62.5% in the secukinumab group, while 33.3% of the placebo group also met those same criteria at that later time point. It is worth noting that some participants in the placebo group may have crossed over to active treatment during the study, which could help explain the change in their results over time, though the data as reported does not detail this further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02432040 · results posted 23 November 2015
According to the results reported on ClinicalTrials.gov, this trial looked at whether atorvastatin (a commonly used cholesterol-lowering medicine) might affect psoriasis symptoms compared to a dummy pill (placebo). A total of 28 people took part — 14 in the atorvastatin group and 14 in the placebo group. Of those, 6 people in the atorvastatin group and 8 in the placebo group completed the full six months. The main thing being measured was change in psoriasis severity, using a scoring system called the PASI (Psoriasis Area and Severity Index), where a higher score means worse psoriasis and the maximum possible score is 72. The reported data shows that, on average, PASI scores went down (meaning less severe psoriasis on the scale) by 2.15 points in the atorvastatin group and 1.69 points in the placebo group over six months. When looking at how many people achieved at least a 50% reduction in their PASI score by six months, the reported figures were 27.3% in the atorvastatin group and 45.5% in the placebo group. At the three-month mark, 36.4% of the atorvastatin group and 18.2% of the placebo group had reached that 50% reduction. The reported data also shows changes in a quality-of-life score related to skin conditions (called the DLQI, where a lower score means less impact on daily life): the atorvastatin group's score changed by −6.5 points and the placebo group's by −2.13 points. Changes in cholesterol-related blood measurements were also recorded for both groups, though the trial report does not label which specific cholesterol type each set of numbers refers to. It is worth noting that this was a small trial, and a relatively large number of participants did not complete it — something to keep in mind when reading these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01468207 · results posted 28 October 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01468207) looked at a medicine called adalimumab (given weekly by injection) compared to a dummy treatment (placebo) in people living with hidradenitis suppurativa (HS) — a skin condition that causes painful lumps, abscesses, and tunnels under the skin. In the first part of the trial, 154 people were assigned to placebo and 153 to adalimumab weekly. After 12 weeks, participants who had been on placebo were reassigned into different groups for a second period, while those on adalimumab continued in various ways. The main thing being measured was whether participants reached a specific level of improvement in their skin — called HiSCR — which meant at least a 50% reduction in the count of abscesses and inflamed lumps, without any increase in other features of the condition. The reported data shows that at 12 weeks, approximately 41.8% of participants receiving adalimumab weekly met the HiSCR improvement threshold, compared with 26.0% of those receiving placebo. When broken down by disease severity stage, the reported figures for adalimumab were 44.6% (moderate stage, known as Hurley Stage II) and 38.6% (severe stage, Hurley Stage III), compared with 29.8% and 21.4% respectively for placebo. For secondary measures, the reported data shows that the proportion of Hurley Stage II participants who had their abscess and inflamed lump count reduced to 0, 1, or 2 was 28.9% in the adalimumab group and 28.6% in the placebo group. For skin pain (among those who reported meaningful pain at the start), about 27.9% of the adalimumab group and 24.8% of the placebo group reported at least a 30% reduction in their worst pain score. A scale measuring overall HS severity (the Modified Sartorius Score, where lower numbers indicate fewer signs of disease) decreased by an average of 24.4 points in the adalimumab group and 15.7 points in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01468233 · results posted 28 October 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01468233) looked at a medicine called adalimumab as a treatment for hidradenitis suppurativa (HS) — a painful skin condition that causes lumps, abscesses, and scarring, particularly in skin folds. The trial was run in two back-to-back periods. In the first period, 163 people received adalimumab given every week and 163 people received a placebo (a dummy treatment with no active medicine). The main thing being measured was how many participants reached a specific level of improvement in their skin — called a "clinical response" — by week 12. After the first period ended, participants were reshuffled into four groups for a second period, with numbers ranging from about 51 to 151 people per group. The reported data shows that by week 12, about 58.9% of participants in the adalimumab group reached the defined clinical response (at least a 50% drop in the count of abscesses and inflamed nodules, with no worsening of other lesions), compared with 27.6% in the placebo group. When broken down by disease severity, the reported figures were 62.4% for adalimumab versus 36.8% for placebo among those with moderate disease (Hurley Stage II), and 55.1% versus 17.1% among those with more severe disease (Hurley Stage III). For secondary measures, the reported data shows that among people with moderate disease, 51.8% on adalimumab had their abscess and nodule count reduced to two or fewer, compared with 32.2% on placebo. Regarding skin pain, among participants who started with meaningful pain levels, 45.7% on adalimumab reported at least a 30% reduction in their worst pain score by week 12, compared with 20.7% on placebo. A score measuring overall disease severity (the Modified Sartorius Score — where a lower number means fewer lesions) showed an average decrease of 28.9 points in the adalimumab group and 9.5 points in the placebo group, though this figure was estimated using a method that filled in missing data from earlier visits. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01083758 · results posted 12 October 2015
According to the results reported on ClinicalTrials.gov, this trial involved 31 people who used a gel called LEO 80185. Of those, 29 completed the trial and 2 did not. The trial was mainly looking at two things: whether the gel was associated with any unwanted reactions (called adverse drug reactions), and whether it had any effect on how well the adrenal glands — small glands that sit above the kidneys — were working. The adrenal glands were tested by giving participants an injection that normally triggers the body to produce a hormone called cortisol; a low cortisol response after this injection can be a sign that the adrenal glands are not functioning as expected. The reported data shows that 3.2% of participants (roughly 1 in 31) experienced an adverse drug reaction considered possibly related to the gel. For the adrenal gland tests, the trial counted how many participants had a cortisol level at or below 18 micrograms per decilitre (a unit of measurement for hormone levels in the blood) after the injection test, which would indicate a potentially reduced adrenal response. According to the results reported on ClinicalTrials.gov, at the 4-week check, 1 participant had a cortisol reading at or below that level at the 30-minute mark, while 0 participants had low readings at both the 30- and 60-minute marks. At the 8-week check, 0 participants had low readings at either time point. The reported data also shows a secondary measure — a change in a hormone called PTH (parathyroid hormone, which is involved in calcium regulation) — decreased by an average of 3.2 ng/L from the start of the trial to the end, though further detail on the timing of this measurement was not broken down separately in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01358578 · results posted 23 September 2015
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called secukinumab (also known as AIN457) for people with moderate to severe chronic plaque psoriasis — a skin condition causing raised, scaly patches. The trial compared two doses of secukinumab (150 mg and 300 mg) against a placebo (a dummy treatment with no active ingredient) and against another existing treatment called etanercept. Around 327 people started in each of the four main groups at the beginning of the trial, with the study running across several phases over roughly a year. The reported data shows that one of the main things measured was how many participants achieved a 75% reduction in their psoriasis skin score (called PASI 75) by week 12 — this is a standard benchmark used in psoriasis studies. According to the results reported on ClinicalTrials.gov, 219 out of 327 participants in the 150 mg secukinumab group, 249 out of 327 in the 300 mg group, and 16 out of 326 in the placebo group reached this target. The reported data also shows that for a skin-clearance rating done by a doctor (scored 0–4, where 0 means clear skin), 167 people in the 150 mg group, 202 in the 300 mg group, and 9 in the placebo group scored 0 or 1 (clear or almost clear) by week 12. For secondary measures, the trial also tracked a 90% skin score reduction (PASI 90) at week 12, where 137, 175, 67, and 5 participants reached that target in the 150 mg, 300 mg, etanercept, and placebo groups respectively. At week 52, among those who had already met the PASI 75 target at week 12, 180, 210, and 103 participants in the 150 mg, 300 mg, and etanercept groups respectively were reported to still be meeting that target. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00769184 · results posted 19 August 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people with chronic plaque psoriasis (a skin condition causing raised, scaly patches). It used a "split-body" design, meaning each participant had two sides of their body treated differently at the same time — one side received a corticosteroid cream combined with a coal tar-based lotion (called LCD), while the other side received the corticosteroid cream combined with a placebo (inactive) lotion. This allowed the researchers to compare the two treatments within the same person. The trial ran across three phases: both treatments together for 2 weeks, then only the LCD or placebo lotion for 4 weeks, and then a 6-week period with no treatment. Doctors rated each side using a standard scale at weeks 2, 6, and 12. The reported data shows the main result was the percentage of participants whose skin was rated as "clear" or "minimal" by their doctor at each check-in. At week 2, this was 33.3% of sides treated with corticosteroid plus LCD, compared with 6.7% of sides treated with corticosteroid plus placebo. At week 6, the reported figures were 46.2% versus 15.4%, and at week 12, 25.0% versus 16.7%. For the secondary outcome — the average percentage improvement in overall skin severity scores (measuring redness, scaling, and skin thickening) — the reported data shows the corticosteroid plus LCD side scored higher improvement at most time points. For example, at week 6 using one scoring method, the LCD side showed 47% mean improvement compared with 25% for the placebo side; by week 12, those figures were 31% versus 12%. Similar patterns were seen across the other scoring method reported. It is worth noting that this was a very small trial — only around 13 people completed all stages — so the numbers above come from a limited group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00708708 · results posted 27 July 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 955 people, all of whom received the medication etanercept (a treatment used for psoriasis). The trial was designed to look at a "stop-start" approach — participants went through multiple treatment cycles, with drug-free breaks in between. The main thing being measured was how long each of those drug-free breaks lasted. Of the 955 people who started the trial, 213 completed it, and 742 did not complete it (the reasons were not detailed in the data provided here). The reported data shows that the average length of the drug-free gap between treatment cycles varied across the study. Between the first and second treatment cycle, the average break was about 12.6 weeks. Between cycles 2 and 3 it was about 10.5 weeks, between cycles 3 and 4 it was about 25 weeks, between cycles 4 and 5 it was about 20.6 weeks, and between cycles 5 and 6 it was about 14.2 weeks. It is worth noting these averages were only calculated for participants who had information available for each specific gap, so the number of people behind each figure may differ. The trial also tracked psoriasis severity scores (called PASI scores — a standardised 0–72 scale where higher numbers mean more severe disease) at the start of each treatment cycle. The reported data shows the average score at the very start of the whole study was 21.0, and scores at the beginning of each new cycle — reflecting how much the condition had returned during the break — generally sat in a lower range, with figures reported between roughly 3.6 and 8.8 across the various cycle starting points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01875991 · results posted 20 May 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 217 people in total (108 in one group and 109 in the other), with 204 completing the study. Participants were people already using the medicine etanercept, and the trial was comparing two different autoinjector devices — called Autoinjector A and Autoinjector B — used to self-inject the medication. The study used a "crossover" design, meaning each person tried both devices over two periods, then answered questions about which they preferred and how each device felt to use. The reported data shows that when asked which autoinjector they preferred overall, 41.7% of participants said they preferred Autoinjector A, 43.5% said they preferred Autoinjector B, and 36.8% expressed no preference (note: the data as submitted lists three figures for the primary question but does not label each figure individually beyond these three values). For the secondary measures, participants rated their nervousness about needles on a scale of 1 (extremely nervous) to 5 (not at all nervous) — scores at the start were around 3.94–4.00 for both devices, with small increases of about 0.31–0.39 points reported at week 4. On ease-of-use questions (scale 1–5), the reported data shows between roughly 87% and 96% of participants gave favourable ratings (scores of 4 or 5) across six different ease-of-use questions for both devices. Around 94% of participants using Autoinjector A and 88% using Autoinjector B reported being very or extremely certain the injection was complete. For convenience, approximately 77% (Autoinjector A) and 87% (Autoinjector B) gave favourable ratings. For discomfort, around 56% using Autoinjector A and 73% using Autoinjector B reported little or no discomfort. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00669916 · results posted 10 April 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people with psoriasis — 18 received a drug called AIN457 (now known as secukinumab), given as an intravenous drip (directly into a vein), and 18 received a placebo (an inactive dummy treatment). All 36 participants completed the study. The main thing the trial was measuring was the change in a psoriasis scoring system called the PASI (Psoriasis Area and Severity Index), which rates the extent and severity of psoriasis on a scale from 0 (no disease) to 72 (worst possible). A lower score over time would indicate improvement. The reported data shows that, by week 4, the average PASI score for the AIN457 group had dropped by 58% from where it started, while the average PASI score for the placebo group had dropped by only 4% from where it started. These percentage changes were calculated across each group as a whole, not for individual participants. The trial also tracked how the drug moved through the body (called pharmacokinetics). The reported data shows that, on average, the drug reached its highest level in the blood roughly 0.11 days (around 2–3 hours) after the infusion, with a peak blood concentration of 74.5 micrograms per millilitre. Other measurements describing how the drug was distributed and cleared from the body were also recorded, but these are highly technical figures intended for researchers rather than general audiences. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01225731 · results posted 30 March 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01225731) tested a medicine called tildrakizumab in people with psoriasis, a skin condition. The trial ran in three parts. In Part 1, around 355 people took part and were given one of four different doses of tildrakizumab (5 mg, 25 mg, 100 mg, or 200 mg) or a placebo (a dummy treatment with no active medicine). Parts 2 and 3 involved further follow-up phases with additional participants continuing on the medicine. The main thing being measured was a skin scoring system called PASI — a tool that rates how red, thick, and scaly psoriasis patches are across the body. The trial's key question was: what share of participants saw their PASI score improve by at least 75% by week 16? The reported data shows that by week 16 in Part 1, the percentage of participants who reached that 75% improvement target was: 33% in the 5 mg group, 64% in the 25 mg group, 66% in the 100 mg group, and 74% in the 200 mg group. In the placebo group, the reported figure was about 4%. Similar patterns were reported at week 12. The trial also measured whether participants reached a 90% or 100% improvement in their PASI score by week 16. For the 90% improvement target, the reported figures ranged from about 12% (5 mg group) up to about 52% (200 mg group), compared with roughly 2% for placebo. For complete skin clearance (100% improvement), the reported figures ranged from 5% (5 mg) to about 17% (200 mg), with 0% in the placebo group. A separate doctor's assessment of overall skin severity also showed higher rates of "cleared" or "minimal" disease in the tildrakizumab groups compared with placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01412944 · results posted 18 March 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01412944) looked at a medicine called AIN457 (also known as secukinumab) in people with psoriasis — a skin condition. The trial focused on participants who had only partially responded to AIN457 in an earlier study, meaning their skin had improved by at least 50% but less than 75% on a standard psoriasis severity scale. These participants were then given either an under-the-skin (subcutaneous) injection or a drip into a vein (intravenous) of AIN457, to see whether a further course of treatment could bring about greater improvement. In total, across the different treatment groups, the trial involved 86 participants. The reported data shows that, among participants who had previously only partially responded, the primary measure — whether their psoriasis severity score improved by 75% or more — was reached by 66.7% of those in the under-the-skin group and 90.5% of those in the intravenous group. A second primary measure, whether a doctor's overall skin assessment rated participants as "clear" or "almost clear," was reported at 66.7% for the under-the-skin group and 33.3% for the intravenous group. For secondary measures, the reported data shows the average psoriasis severity score fell by around 65–76% from the starting point in the under-the-skin group, and by around 75–91% in the intravenous group, across various time points. The reported data also shows varying proportions of participants reached higher levels of skin clearance, and different proportions reported little or no impact on their daily quality of life, depending on which group they were in and when the measurement was taken. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01483924 · results posted 20 February 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01483924) enrolled 60 people in total, with 12 participants assigned to each of five groups: a placebo (inactive treatment) group, and four groups receiving different doses of a medicine called Apo805K1 (10 mg, 30 mg, 60 mg, or 100 mg). The trial was designed to track how many participants experienced adverse events (unwanted health changes), and to measure how the medicine moved through the body at different doses. It also measured changes in a skin condition score called the PASI (Psoriasis Area and Severity Index), which rates the severity of psoriasis on a scale from 0 (no disease) to 72 (worst possible). Not everyone finished the trial — 10 completed in the placebo group, 12 in the 10 mg group, 11 in the 30 mg group, 8 in the 60 mg group, and 10 in the 100 mg group. The reported data shows that for the primary outcome — the number of people who experienced at least one adverse event — 4 out of 12 in the placebo group reported an event, compared with 5 out of 12 in the 10 mg group, 7 out of 12 in the 30 mg group, 6 out of 12 in the 60 mg group, and 5 out of 12 in the 100 mg group. For the secondary outcomes tracking how the medicine behaved in the body on Day 14, the reported peak level of the medicine in the blood rose with higher doses (18.3, 53.0, 138.5, and 164.9 ng/mL for the 10 mg, 30 mg, 60 mg, and 100 mg groups respectively). The time it took to reach that peak was reported as 4, 3, 3, and 4 hours across the same dose groups, and the time for the medicine to reduce by half in the body was reported as approximately 2.6–2.8 hours across all dose groups. The reported data shows that for the PASI skin score outcome, all groups showed a decrease (improvement) in their score from the start of the trial to Week 12. The placebo group's score decreased by 3.8 points on average, while the Apo805K1 groups decreased by 3.8 points (10 mg), 2.0 points (30 mg), 3.4 points (60 mg), and 2.8 points (100 mg). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00156247 · results posted 16 February 2015
According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two medicines — etanercept and acitretin — in people with psoriasis. Psoriasis is a skin condition that causes red, scaly patches. The trial enrolled 9 participants in total, though only 5 completed the study and 4 did not finish. The main thing the trial was measuring was how many participants saw their psoriasis score (called a PASI score, which rates the area and severity of skin involvement on a scale from 0 to 72) improve by at least 75% after six months on the combination treatment. The reported data shows that 12.5% of participants reached that 75% improvement mark at six months. For a lower improvement threshold — a 50% reduction in the PASI score — the reported figure was 50% of participants. The trial also used a second scoring tool called the Physician Global Assessment (PGA), where a doctor rates the overall appearance of the psoriasis on a scale of 0 (clear skin) to 5 (severe disease). The reported data shows that 37.5% of participants were rated as "clear" or "almost clear" on that scale at six months. It is worth noting that this was a very small trial — only 9 people started and only 5 finished — so the reported percentages are based on a handful of individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01646073 · results posted 19 January 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01646073) looked at adalimumab (given every other week) compared to a placebo (an inactive treatment) in people with psoriasis. The trial ran in two back-to-back 12-week periods. In the first period (Period A), 87 people received placebo and 338 received adalimumab. In the second period (Period B), those who had been on placebo were switched to adalimumab, while those already on adalimumab continued. By the end of each period, the vast majority of participants completed the study. The main thing being measured was a scoring system called PASI — a 0-to-72 scale that rates redness, skin thickening, and flaking across different body areas — specifically, how many participants saw their score drop by 75% or more (known as a "PASI 75" response). The reported data shows that at the 12-week mark (the trial's primary measurement point), 11.5% of participants in the placebo group reached the PASI 75 threshold, compared with 77.8% in the adalimumab group. Looking at earlier time points within Period A, the reported figures for the adalimumab group reaching PASI 75 were 9.8% and 45.3% at interim checks, versus 0% and 2.3% for the placebo group at those same points. The reported data also shows that across Period A, the average PASI score fell by about 20% from where it started in the placebo group, and by about 82% in the adalimumab group. For Period B — when the former placebo group had switched to adalimumab — the reported PASI 75 figures at various time points ranged from around 51.8% to 90.6% for the switched group, and from 87.1% to 87.7% for those who had been on adalimumab throughout, with average score reductions of approximately 91% in both groups by that stage. The reported data also includes results at stricter thresholds: at the Week 4 mark of Period A, 31.7% of the adalimumab group and 1.1% of the placebo group had achieved a 50% or greater PASI reduction, while a 90% or greater reduction was seen in 2.7% of the adalimumab group and 0% of the placebo group, and a 100% reduction was seen in 0% of either group at that early stage. By Week 12, a 90% or greater reduction was reported in 23.4% of the adalimumab group versus 0% in the placebo group, and a 100% reduction in 3.8% versus 0%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01989689 · results posted 19 December 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 24 people in total — 11 in one group and 13 in the other. It used a "crossover" design, meaning each group took turns receiving either etanercept (a medicine) or a placebo (an inactive treatment) across two three-month periods. The trial was measuring vascular function — essentially, how well blood vessels can widen in response to increased blood flow — using an ultrasound test on the brachial artery (a major artery in the upper arm). This test is called flow-mediated dilation, or FMD, and it records results as a percentage change in the artery's width. The reported data shows FMD measurements taken at three points in time. At the start of the trial (baseline), the group that received etanercept first recorded an average FMD of 9.71%, while the group that received placebo first recorded 11.15%. After the first three-month treatment period, the etanercept-first group recorded 8.77% and the placebo-first group recorded 7.79%. After the full six months (when each group had switched treatments), the etanercept-first group recorded 8.34% and the placebo-first group recorded 7.73%. The reported data does not include a separate statistical comparison between the groups, so no conclusions about differences between treatments can be drawn from the numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01120223 · results posted 1 December 2014
According to the results reported on ClinicalTrials.gov, this trial involved 78 people who all received a gel called LEO 80185, applied once daily. The trial was measuring a number of things related to safety and body chemistry, including whether the gel was associated with any unwanted reactions, whether it changed calcium levels in the blood, and whether it changed levels of a hormone called PTH (parathyroid hormone, which helps the body regulate calcium). The trial also tracked how many participants' scalp psoriasis was rated as "clear" or "almost clear" by their doctor after two weeks of use. Of the 78 who started, 74 completed the trial and 4 did not. The reported data shows that 6.4% of participants (roughly 5 out of 78 people) experienced an adverse drug reaction — that is, an unwanted event that the doctor considered may have been related to the gel. For blood calcium levels, the reported data shows very small changes: at week 4, the average change was −0.014 mmol/L (a unit used to measure substances in the blood), and at week 8 it was −0.002 mmol/L. For PTH levels, the reported change from the starting point was +1.2 ng/L at week 4 and −2.8 ng/L at week 8. As a secondary measure, 37 out of 78 participants were rated by their doctor as having "controlled disease" (scored as clear or almost clear on a 6-point scale) at the two-week mark. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01309737 · results posted 19 September 2014
According to the results reported on ClinicalTrials.gov, this trial investigated a medicine called CP-690,550 (also known as tofacitinib) in people with psoriasis, a skin condition. Participants were divided into three groups during the first 16 weeks: 383 people received the lower dose (5 mg), 381 received the higher dose (10 mg), and 196 received a placebo (a dummy treatment with no active ingredient). After week 16, those who had been on placebo were switched to one of the two active doses for a further 36 weeks. In total, the trial ran for up to 52 weeks. The reported data shows that the main thing being measured was the proportion of participants whose skin was rated as "clear" or "almost clear" by their doctor at week 16, using a standard 5-point scoring tool. According to the results reported on ClinicalTrials.gov, approximately 46% of people in the lower-dose group and 59% in the higher-dose group were rated clear or almost clear at week 16, compared with about 11% in the placebo group. The reported data also shows that the affected area of skin (measured as a percentage of body surface) changed by around −55% in the lower-dose group and −67% in the higher-dose group, versus about −9% in the placebo group. On a separate measure of skin severity (PASI 90, meaning at least a 90% reduction in a combined severity score), roughly 24% of the lower-dose group and 39% of the higher-dose group reached that level, compared with about 5% in the placebo group. Participants also completed a quality-of-life questionnaire scored from 0 (best) to 30 (worst); starting scores were around 13 across all groups, and by week 16 the reported changes were approximately −7 points in the lower-dose group, −9 points in the higher-dose group, and −3 points in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01644396 · results posted 17 September 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 50 adults who received the medicine adalimumab for plaque psoriasis. All 50 participants completed the study — none dropped out. The trial was primarily measuring how many people saw a large improvement in their psoriasis symptoms by week 24, using a scoring tool called the PASI (Psoriasis Area and Severity Index), which rates the redness, thickness, and scaling of skin plaques across the body on a scale from 0 to 72 — the higher the score, the more severe the psoriasis. The trial also tracked a doctor's overall rating of skin clearance at various points in time. The reported data shows that by week 24, 82% of participants had their PASI score reduce by at least 75% from where it started — meaning their measured psoriasis severity had dropped by at least three-quarters according to that scoring system. For the doctor's overall skin rating (called the Physician's Global Assessment, or PGA), the reported data shows that at the final time point measured, 70% of participants were rated as having completely clear skin, and 80% were rated as either completely clear or having only minimal signs. These percentages appeared to build over the course of the study, starting lower in the earlier weeks. Some additional blood measurements (haemoglobin, red blood cell counts) were also recorded, and the reported data shows only very small changes from the starting point, though the trial's reporting does not describe what those changes mean clinically. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01714544 · results posted 23 July 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 60 participants, all of whom received a cream called Cloderm Cream. Of those 60 people who started the trial, 57 completed it, and 3 did not finish. The trial was measuring how participants' skin condition was rated by a doctor or investigator using a scoring tool called the Investigator's Global Assessment (IGA) — a scale used to assess the overall appearance of a skin condition, where a score of 0 means "clear" and 1 means "almost clear." The reported data shows that 15% of participants received an IGA score of either "clear" (0) or "almost clear" (1) by the end of the study. In plain terms, this means that out of every 100 people in the trial, roughly 15 were rated by the investigator as having skin that looked clear or almost clear. No other outcome measures were included in the submitted results data. It is worth noting that this trial had only one group — there was no comparison group receiving a different treatment or a dummy cream (placebo), so the reported figure represents only the participants who used Cloderm Cream. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01893567 · results posted 11 July 2014
According to the results reported on ClinicalTrials.gov, this trial involved 28 participants, all of whom completed the study with no drop-outs. The trial was looking at a single treatment group using Clobex Spray, a topical spray used for psoriasis. The study measured how severe a specific skin lesion (a patch of psoriasis) appeared to be, using a numbered rating scale — once as rated by the participant themselves, and once as rated by the treating clinician. The reported data shows that at the end of the study, participants rated the severity of their target lesion at an average score of 4.0 out of 10 on a scale where 0 means "no psoriasis" and 10 means "very severe psoriasis." The reported data also shows that clinicians rated the same lesions at an average score of 3.3 out of 10 on the same scale. Because the trial did not include a comparison group (such as a placebo or a different treatment), these end-of-study numbers alone do not tell us how scores may have changed from the beginning of the trial — that starting-point data was not reported in the results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01206660 · results posted 3 July 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01206660) involved 120 people in total — 60 received a desoximetasone 0.25% spray and 60 received a placebo (an inactive spray used for comparison). All 120 participants completed the study. The trial was measuring two main things: whether a doctor rated a participant's skin as "clear" or "almost clear" overall, and whether specific target areas of psoriasis showed very low scores for redness, flaking, and skin thickening. There was also a secondary measure looking at an overall skin severity score given by the doctor at day 28. The reported data shows that for the first main measure (the doctor's overall rating of "clear" or "almost clear"), 32 out of 60 participants in the desoximetasone spray group reached that rating, compared with 11 out of 60 in the placebo group. For the second main measure (the target lesion assessment), 32 out of 60 in the desoximetasone spray group met the low-score threshold across all three signs, compared with 10 out of 60 in the placebo group. For the secondary measure — the doctor's overall severity score on a scale from 0 (no evidence of disease) to 5 (severe) — the reported average score at day 28 was 1.73 for the desoximetasone spray group and 0.85 for the placebo group. The reported data does not include further explanation for why the placebo group had a lower average severity score on this secondary measure. It is worth noting that these numbers alone do not tell the whole story of a clinical trial, and the reported data on ClinicalTrials.gov does not include all context that would normally appear in a published medical paper. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01235728 · results posted 11 June 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 24 people in total, split evenly across eight groups of three participants each. The trial was testing a topical (applied to the skin) treatment called MK-0873 for psoriasis. Because it was a crossover-style study, participants received different treatments on different skin lesions or at different times, allowing the researchers to compare MK-0873 directly against a vehicle (an inactive version of the cream with no active ingredient) and against an existing treatment called calcitriol. The main thing being measured was how much a "Target Lesion Severity" score changed — this score (ranging from 0 to 12) added up ratings for redness, skin thickness, and scaling on each lesion. The reported data shows that, for the primary measurement, lesions treated with MK-0873 had an average score reduction of around 47%, while lesions treated with the inactive vehicle cream had an average score reduction of around 43%. For a secondary comparison, lesions treated with calcitriol showed an average score reduction of around 57%, while lesions treated with MK-0873 showed a reduction of around 48%. The reported data also shows that a small amount of MK-0873 was detected in the bloodstream — at a mean level of 3.6 nM (nanomolar, a very small unit of measurement) — at trough points (the lowest level in the blood, measured roughly 12 hours after a dose). Of the 24 people who started the trial, 23 completed it; one person in one of the groups did not finish, though the reason was not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01186744 · results posted 4 June 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 666 participants in total across several groups, all of whom had psoriasis. The trial was testing a medicine called CP-690,550 (also known as tofacitinib) at two different doses — 5 mg and 10 mg, taken twice daily. The study was designed in three phases: an initial treatment period (Period A), a withdrawal period where some participants were switched to a dummy tablet called a placebo (Period B), and a re-treatment period (Period C). The trial measured how participants' psoriasis responded using two scoring tools — the PASI score (a detailed measure of how much of the body is affected and how severe the patches are) and the PGA score (a doctor's overall rating from "clear" to "severe"). The reported data shows that during the withdrawal phase (Period B), among those who had been on the 5 mg dose, around 90% who stayed on the medicine still met the PASI75 response threshold (meaning their psoriasis score had dropped by at least 75% from the start) at an early time point, compared with about 63% of those switched to placebo; by a later time point in that period, those figures had dropped to roughly 63% and 32% respectively. Similar patterns were reported for the 10 mg group. For the doctor's overall rating (PGA), the reported data shows that around 81% of those continuing on 5 mg were rated "clear" or "almost clear" at an early point in Period B, compared with about 57% on placebo; for the 10 mg group the figures were approximately 80% versus 52%. The reported data also shows that during re-treatment (Period C), participants who had previously been on the 10 mg dose and were then switched back after a break reached response thresholds at higher rates over time than those re-starting the 5 mg dose. For the secondary outcomes, the median time reported to reach the PASI75 threshold during the first treatment period was approximately 24.3 weeks for the 5 mg group and 8.7 weeks for the 10 mg group; similarly, the median time to a "clear" or "almost clear" doctor rating was about 24.1 weeks for the 5 mg group and 8.1 weeks for the 10 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01043393 · results posted 2 June 2014
According to the results reported on ClinicalTrials.gov, this trial involved 24 adults with psoriasis (a skin condition), split into two groups of 12. One group had psoriasis covering between 10% and 15% of their body surface area, and the other group had psoriasis covering more than 15% of their body surface area. All 24 participants completed the study. The trial was measuring whether a topical (applied to the skin) treatment affected the body's hormonal stress-response system — specifically a system called the HPA axis, which helps regulate hormones — and also looked at changes in the amount of skin affected by psoriasis and how doctors rated the overall severity of the condition. The reported data shows that, when it came to the main thing being measured (possible suppression of the hormonal stress-response system, assessed at day 28), 2 out of 12 participants in the 10–15% body surface area group and 3 out of 12 in the more-than-15% group showed signs of possible suppression. For the secondary measurements, the reported data shows that the average change in the percentage of body surface area affected by psoriasis was 5.50 percentage points for the first group and 3.50 percentage points for the second group. Doctors' overall severity ratings (on a scale of 0 to 5, where 0 means clear skin and 5 means severe) changed by an average of 1.83 points for the first group and 1.33 points for the second group. It is not reported in the submitted data whether these changes were increases or decreases from the starting point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01241591 · results posted 7 May 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,101 adults with psoriasis across four groups. The largest three groups (around 329–335 people each) received one of two doses of an investigational oral medicine called CP-690,550 (now known as tofacitinib) — either 5 mg or 10 mg twice daily — or an existing injectable treatment called etanercept. A smaller fourth group of 107 people received dummy (placebo) treatments only. The trial ran for 12 weeks and was measuring two main things: how many participants' skin was rated by a doctor as "clear" or "almost clear" (using a scale called the Physician's Global Assessment, or PGA), and how many participants achieved at least a 75% reduction in the overall area and severity of their psoriasis (a measure called PASI75). The reported data shows the following results at the 12-week mark. For the "clear or almost clear" skin rating, the figures were: 47% in the 5 mg group, 68% in the 10 mg group, 66% in the etanercept group, and 15% in the placebo-only group. For the 75% reduction in psoriasis severity (PASI75), the reported figures were: 40% in the 5 mg group, 64% in the 10 mg group, 59% in the etanercept group, and 6% in the placebo-only group. The reported data also shows that at the start of the trial, average psoriasis severity scores (on a 0–72 scale) were similar across all groups, ranging from roughly 22.7 to 23.3, and that these scores were lower in the treatment groups by week 12. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00601107 · results posted 5 May 2014
According to the results reported on ClinicalTrials.gov, this trial looked at a medication called doxercalciferol (a form of vitamin D) as a treatment for psoriasis. A total of 111 people took part, split across four groups: 27 received a placebo (a dummy pill with no active ingredient), 31 received a low dose of 2.5 micrograms per day, 28 received a medium dose of 5 micrograms per day, and 25 received a higher dose of 7.5 micrograms per day. The trial ran for up to 24 weeks. The main thing being measured was whether participants' psoriasis — assessed using a standard scoring system called the PASI score, which rates the extent and severity of skin involvement on a scale from 0 (no disease) to 72 (worst possible) — improved by at least half by week 12. The reported data shows that at week 12, the proportion of people whose PASI score dropped by at least 50% was similar across all groups: 20% in the placebo group, 20% in the 2.5 mcg group, roughly 18% in the 5 mcg group, and 20% in the 7.5 mcg group. At week 24, the reported figures were 36% for the placebo group, 20% for the 2.5 mcg group, about 21% for the 5 mcg group, and 32% for the 7.5 mcg group. A separate measure asked doctors to rate each participant's skin as "clear," "almost clear," "mild," "moderate," or "severe." The reported data shows that at week 12, 0% of placebo participants were rated clear or almost clear, compared with about 7%, 4%, and 0% across the three doxercalciferol dose groups respectively. At week 24, those figures were 8% (placebo), 3% (2.5 mcg), 11% (5 mcg), and 16% (7.5 mcg). It is also worth noting that a sizeable number of participants did not complete the trial — for example, 13 out of 27 in the placebo group and 12 out of 28 in the 5 mcg group did not finish — which the reported data does not explain further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01313221 · results posted 2 May 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 310 people in total. Of these, 287 were randomly assigned to one of two treatment groups: 144 people received etanercept injections twice a week (50 mg twice weekly), and 143 received etanercept injections once a week (50 mg once weekly) combined with a topical (applied-to-skin) treatment. A further 23 people took part in a non-randomised group and did not complete the study. The trial was measuring changes in psoriasis severity using a scoring system called PASI (Psoriasis Area and Severity Index), which rates redness, skin thickness, scaling, and the area of skin affected on a scale from 0 (no disease) to 72 (most severe disease). The main question the trial was designed to answer was how each group's PASI score changed between week 12 and week 24 of the study. The reported data shows that for the primary measure — the percentage change in PASI score between week 12 and week 24 — the twice-weekly injection group recorded a 17.02% improvement, while the once-weekly injection plus topical group recorded a 0.86% improvement over that same period. Looking back from the very start of the trial (baseline), the reported data shows both groups had notable reductions in their PASI scores across all measured time points. By week 24, the twice-weekly group showed a 71.71% reduction from baseline and the once-weekly plus topical group showed a 72.56% reduction. The reported data also shows the proportion of participants who reached certain score-reduction milestones: at week 24, 78.2% of the twice-weekly group and 88.7% of the once-weekly plus topical group had at least a 50% reduction in their score; 59.2% and 60.3% respectively had at least a 75% reduction; and 32.4% and 27.0% respectively had at least a 90% reduction. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00293722 · results posted 26 February 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,291 people who had been diagnosed with psoriatic arthritis — a condition involving both joint inflammation and the skin condition psoriasis. By the end of the study, 864 participants had completed it, while 427 did not finish. The trial was primarily measuring how many participants experienced unwanted medical events (called adverse events) or serious medical events (such as hospitalisation or life-threatening situations) during the 52 weeks they were followed. It also tracked several measures of how their joint and skin condition changed over that time. The reported data shows that 38.1% of participants experienced some kind of adverse event (an unwanted medical occurrence) during the study period, and 6.0% experienced a serious adverse event. For the additional measurements taken at week 52 compared to the start of the study: the portion of skin affected by psoriasis started at an average of 9.7% of the body's surface area and was reported to have decreased by 6.6 percentage points. A joint disease activity score (which runs from 0 to 10, where higher means more active disease) started at an average of 4.8 and was reported to have decreased by 2.2 points. A joint tenderness score (ranging from 0 to 84, where higher means more tenderness) started at an average of 9.9 and decreased by 4.1 points. A doctor's rating of overall disease activity (on a 0–100 scale, where higher means more active disease) started at an average of 60.8 and decreased by 39.8 points. The reported data also shows that 597 participants had nail involvement at the start of the study, with 456 showing nail involvement at a later check-in and 259 at another point — though the exact timing of these later figures was not clearly specified in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01087788 · results posted 25 February 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 409 people with psoriatic arthritis, split across three groups: 136 received a placebo (inactive treatment), 138 received a medicine called certolizumab pegol (CZP) at a dose of 200 mg every two weeks, and 135 received CZP at 400 mg every four weeks. The trial ran in stages — a 24-week blinded period, a further 24-week dose-blinded period, and then an open-label period — and was measuring things like joint tenderness and swelling, physical function, skin involvement, and X-ray changes to joints over time. The reported data shows that for the main joint-response measure at week 12 (known as ACR20, meaning at least a 20% improvement across several joint and symptom scores), 24.3% of placebo participants met that threshold, compared with 58.0% in the 200 mg group and 51.9% in the 400 mg group. At week 24, those figures were 23.5%, 63.8%, and 56.3% respectively. For physical function (measured on a disability scale where lower scores mean less difficulty), the placebo group's average score changed by −0.19 points from the start, while the two CZP groups changed by −0.54 and −0.46 points. In the subgroup of participants with more significant skin involvement, 15.1% of placebo participants showed a 75% or greater improvement in their skin score at week 24, compared with 62.2% and 60.5% in the two CZP groups. For X-ray joint damage scores at week 24, the reported average change from baseline was 0.18 for placebo, −0.02 for the 200 mg group, and 0.09 for the 400 mg group (on a scale where 0 is no damage and higher numbers indicate more damage). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01077128 · results posted 21 February 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 500 people in Greece who had been diagnosed with psoriasis. Of those, 433 completed the study, while 67 did not finish. The trial ran over 12 months and was primarily measuring changes in participants' quality of life related to their skin condition, using a scoring tool called the Dermatology Life Quality Index (DLQI) — a questionnaire where scores range from 0 to 30, with higher scores meaning a greater impact on daily life. A doctor's assessment of disease severity (rated on a 0–5 scale) and broader health-related quality of life questionnaires were also tracked as secondary measures. The reported data shows that the average change in DLQI scores (reflecting how much participants' quality-of-life scores shifted from their starting point) was 4.9 points at month 1, rising to 9.3 at month 4, 11.3 at month 8, and 12.1 at month 12 — with larger numbers indicating a bigger shift away from the starting score. For the doctor's severity assessment, the reported data shows that 66.2% of participants showed some improvement at month 1, rising to 95.1% at month 4, 97.5% at month 8, and 97.9% at month 12. On a separate general health scale (EQ-5D VAS, scored 0–100 from worst to best imaginable health), the average change from the starting score was reported as 12.5 points at month 1, 25.9 at month 4, 31.8 at month 8, and 35.9 at month 12. For the adverse events (unwanted medical occurrences) outcome, the data as submitted lists 500 participants but specific figures for the number or type of adverse events were not reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01768013 · results posted 30 December 2013
According to the results reported on ClinicalTrials.gov, this trial involved 13 participants who were all given a treatment called LEO 90105 Ointment. All 13 participants completed the study, with none dropping out. The trial was designed to measure how much of one of the active ingredients — betamethasone dipropionate — was absorbed into the bloodstream after the ointment was applied to the skin. This type of study, known as a pharmacokinetic study, looks at how a substance moves through the body rather than at whether a treatment improves a condition. The reported data shows that two specific measurements were used to track how much of the ingredient entered the blood: the peak level reached in the bloodstream (called Cmax, or maximum observed plasma concentration), and the total amount present in the blood over time (called AUClast, which captures the overall exposure from the first dose until the last measurable amount was detected). For both of these measurements, across all reported time points and all participant groups, the submitted data lists the values as "NA" — meaning the actual figures were not reported in the structured results provided to ClinicalTrials.gov. The reported data therefore does not include numerical results for any of the primary outcome measures in this trial. No figures for blood concentration levels were made available in the submitted results, so no conclusions about the extent of absorption can be drawn from the data as filed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01607853 · results posted 24 December 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 24 participants, all of whom completed the study with no drop-outs. Each participant had psoriasis lesions that were treated in four different ways at the same time (on different areas of skin), so the 24 people each contributed data for all four treatment conditions being compared. The trial was measuring how the appearance of psoriasis lesions changed over 22 days using a scoring system called the Total Clinical Score. This score runs from 0 (least severe) to 9 (most severe), and it combines ratings of redness, scaling, and skin thickening. The reported data shows the change in lesion scores from the start of the trial to Day 22 (the primary measurement). A negative number means the score went down — that is, the lesion appeared less severe than at the start. For the gel left on for 24 hours, the reported average change was −4.9 points. For the gel removed after 10 minutes, it was −3.6 points, and for removal after 20 minutes, it was −3.7 points. The vehicle (a gel containing no active ingredient, used as a comparison), applied for 24 hours, showed a reported average change of −1.3 points. The reported data also shows scores were measured at several earlier time points (Days 4, 8, 11, 15, and 18), and across all of these check-ins the pattern of numbers was broadly similar to the Day 22 result. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01265823 · results posted 11 March 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 150 people with psoriasis, all of whom received the medication adalimumab. Of the 150 who started, 143 completed the study and 7 did not. The trial was measuring two main things: how much participants' psoriasis skin symptoms improved (using a scoring system called the PASI, which rates skin redness, thickness, scaling and the area affected on a scale from 0 to 72, with higher scores meaning more severe psoriasis), and how much psoriasis appeared to affect participants' daily life and wellbeing (using a questionnaire called the DLQI, scored from 0 to 30, where a higher score means a greater impact on quality of life). These were measured at 4 weeks and again at 16 weeks. The reported data shows that, when looking at skin symptoms, 31% of participants had at least a 75% reduction in their PASI score at week 4, rising to 85% of participants at week 16. Regarding the quality-of-life questionnaire, 65% of participants had a DLQI score below 6 (meaning psoriasis was reported to have little or no effect on their daily life) at week 4, and this rose to 86% at week 16. As a secondary measure, the reported data shows the average DLQI score across all participants started at 11.7 at the beginning of the trial, dropped to 5.2 at week 4, and further dropped to 1.8 at week 16. It is worth noting that this trial had only one group — everyone received adalimumab — so there was no comparison group (such as a placebo or different treatment) included in these reported figures. The reported numbers therefore describe what was observed in this single group of participants over the course of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00953329 · results posted 15 February 2013
According to the results reported on ClinicalTrials.gov, this clinical trial (NCT00953329) enrolled only one participant and was testing a treatment called alefacept. The trial had one group, in which the single participant received alefacept. The study was looking at how the treatment performed as its primary outcome measure. The reported data shows that the trial was terminated before it could be completed. Of the one person who started the study, none completed it. Because the study was terminated early, no outcome measurement data was collected or reported for the primary outcome measure. The results section notes simply "terminated study" with no numbers available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00789880 · results posted 22 January 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 82 people across six groups. Participants were split into three broad categories — those with atopic dermatitis (eczema), those with psoriasis, and healthy volunteers without either condition — and within each category, people were randomly assigned to receive either oral vitamin D3 or a placebo (a dummy pill) for 21 days. The trial was measuring changes in the activity of two specific proteins in the skin — cathelicidin (CAMP) and human beta-defensin 3 (HBD-3) — both of which are described in the reported data as playing a role in the skin's ability to resist infection. Small skin samples (biopsies) were taken and analysed at the start and end of the 21-day period. Most participants completed the study, with a small number (five in total) not finishing. The reported data shows the results as changes in a laboratory measurement called a "cycle threshold" number — a technical way of gauging how much of each protein's genetic signal was present in the skin. For the positive or negative numbers reported, a positive value means the signal went up from the starting point and a negative value means it went down. For the eczema (AD) group, the reported CAMP signal change was −0.4 (vitamin D, affected skin) versus +0.1 (placebo, affected skin), and −0.6 (vitamin D, unaffected skin) versus +0.7 (placebo, unaffected skin). For the healthy volunteer group, the reported CAMP signal change was +1.2 (vitamin D) versus +0.3 (placebo). For the psoriasis group, the reported CAMP change was −0.9 (vitamin D, affected skin) versus +0.2 (placebo, affected skin), and −0.6 (vitamin D, unaffected skin) versus +0.7 (placebo, unaffected skin). For the HBD-3 protein, the eczema group reported changes of −0.1 (vitamin D, affected skin) versus −0.8 (placebo, affected skin), and −0.1 (vitamin D, unaffected skin) versus +1.4 (placebo, unaffected skin). The healthy volunteer group reported HBD-3 changes of +0.2 (vitamin D) versus +1.2 (placebo). The psoriasis group reported HBD-3 changes of +0.8 (vitamin D, affected skin) versus −1.6 (placebo, affected skin), and −1.5 (vitamin D, unaffected skin) versus −1.5 (placebo, unaffected skin). No additional outcome measures beyond these primary results appear in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00678210 · results posted 19 December 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 197 people with psoriasis across four groups: 49 received a 2 mg dose of CP-690,550 (now known as tofacitinib), 49 received a 5 mg dose, 49 received a 15 mg dose, and 50 received a placebo (a dummy treatment with no active ingredient). The trial's main goal was to measure how many participants saw their psoriasis skin score — called the PASI score, a standard scale doctors use to measure the area and severity of psoriasis across the body — improve by 75% or more after 12 weeks of treatment. The reported data shows that at the 12-week mark, 25% of participants in the 2 mg group, 40.8% in the 5 mg group, and 66.7% in the 15 mg group reached that 75% improvement threshold, compared with 2% in the placebo group. For secondary measures, the reported data shows that at week 12, a 50% improvement in the PASI score was recorded in 41.7%, 55.1%, and 79.2% of participants in the 2 mg, 5 mg, and 15 mg groups respectively, versus 14% in the placebo group. A 90% improvement at week 12 was reported in 14.6%, 18.4%, and 33.3% across the three dose groups, compared with 0% in the placebo group. A separate doctor's overall rating of skin clearance ("clear" or "almost clear") at week 12 was recorded for 24.5%, 44.9%, and 56.3% of participants in the three dose groups, against 14% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00454584 · results posted 21 November 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 903 participants with psoriasis across three treatment groups during the main controlled period: 347 received etanercept, 209 received ustekinumab at a 45 mg dose, and 347 received ustekinumab at a 90 mg dose. The trial was primarily measuring how many participants had their psoriasis skin score (called the PASI score, a 0–72 scale where lower is better) improve by 75% or more after 12 weeks of treatment. After the controlled period ended, participants continued into a follow-up phase to look at what happened when treatment was stopped and then restarted. The reported data shows that at the 12-week mark, 197 out of 347 participants in the etanercept group, 141 out of 209 in the ustekinumab 45 mg group, and 256 out of 347 in the ustekinumab 90 mg group reached that 75% improvement threshold in their PASI score. For the secondary measures, the reported data shows that when a doctor rated participants' skin as "cleared" or "minimal" at week 12, those numbers were 170, 136, and 245 participants respectively across the three groups. Looking at an even higher bar — a 90% or greater improvement in PASI score — the reported numbers were 80, 76, and 155 participants across the three groups. For participants in the ustekinumab groups who stopped and then restarted treatment, the reported data shows the difference in PASI score between the end of the first treatment period and after 12 weeks of retreatment was −0.99 for the 45 mg group and −0.30 for the 90 mg group (meaning scores at retreatment were slightly lower, indicating marginally less severe psoriasis than at the end of the first period), though this data was not reported for the etanercept group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01022502 · results posted 16 October 2012
According to the results reported on ClinicalTrials.gov, this trial involved 38 participants, with 35 completing the study and 3 not finishing. The trial was comparing two forms of an ointment made from a plant-based ingredient called Indigo Naturalis — a "crude" (less processed) version and a "refined" (more processed) version — for the treatment of psoriasis. Each participant used both ointments at the same time, one on each side of the body, for 8 weeks. The study measured changes in the severity of psoriasis patches using a scoring system called the Psoriasis Severity Index (PSI), which rates redness, flaking, and skin thickening on a scale from 0 (absent) to 12 (very severe), as well as changes in the size of a target patch of psoriasis. The reported data shows that, at the 8-week mark, participants using the crude ointment had an average PSI score change of −5.7 points, while those using the refined ointment had an average change of −6.0 points (a negative number meaning the score went down from where it started). The reported data also shows that the target psoriasis patch area cleared by around 39% for the crude ointment side and about 41% for the refined ointment side. A combined measure of patch size and severity showed an overall improvement of approximately 75% for both ointment types. For the secondary outcomes, 21 out of 35 participants rated the crude ointment as "excellent" or "cleared" on a 6-point scale, compared with 23 out of 35 for the refined ointment. When asked which ointment they preferred, the reported data shows that 31 participants chose the refined ointment and only 1 chose the crude ointment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01126619 · results posted 11 October 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 103 people who were already receiving an anti-TNF medicine (a type of treatment that works by blocking a protein involved in inflammation) for psoriasis, a skin condition. Of those 103 participants, 86 completed the study and 17 did not finish. The trial was measuring changes in psoriasis severity over time, using several scoring tools — including a skin severity score called PASI (which runs from 0 to 72, where higher means more severe), a quality-of-life questionnaire, and assessments where both doctors and patients compared photographs of the skin taken at the start of the study and at 24 weeks. The reported data shows that, for the main measure (PASI score), the average percentage improvement from the starting point was reported at four separate time points across the study: approximately 49%, 76%, 88%, and 90% reductions. For the second main measure — the proportion of participants whose PASI score fell by at least 75% from their starting level — the reported figures at those same four time points were roughly 31%, 51%, 67%, and 71% of participants. For the quality-of-life questionnaire (DLQI, scored 0–30), the reported average percentage improvements at the four time points were approximately 53%, 66%, 74%, and 66%. When doctors compared before-and-after photographs at 24 weeks using a scale from –5 (considerable worsening) to +5 (considerable improvement), the average score reported was 1.51; patients rating their own photographs reported the same average score of 1.51. The reported data shows that for the doctor's overall static assessment of skin appearance (comparing all participants' photos at the start versus at week 24), no participants were rated "clear" or "almost cleared" at the start, while at week 24, 14 were rated clear and 38 were rated almost cleared, with the remaining participants spread across milder categories — though the exact baseline numbers for the most severe categories were not fully detailed in the submitted data for all categories. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01008995 · results posted 14 September 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 322 adults across two main groups during its initial controlled period — 162 people received a placebo (a dummy treatment with no active ingredient) and 160 people received a medicine called ustekinumab at a 45 mg dose. The trial was primarily measuring how many participants saw their psoriasis improve significantly — specifically, at least a 75% reduction in a standardised skin score called the PASI (Psoriasis Area and Severity Index), which rates psoriasis severity on a scale from 0 (mild) to 72 (severe). After this controlled period, most participants continued into a second phase where they all received the active medicine. The reported data shows that at the 12-week mark, 132 out of 160 participants in the ustekinumab group had achieved that 75% or greater improvement in their PASI score, compared with 18 out of 162 participants in the placebo group. For a second measure — a doctor's overall rating of skin clearance, scored as either "cleared" (0) or "minimal" (1) — the reported data shows 126 out of 160 participants in the ustekinumab group reached that rating at week 12, compared with 24 out of 162 in the placebo group. The trial also tracked participants' quality of life using a skin-related questionnaire (scored 0–30, where lower means better quality of life). The reported data shows the ustekinumab group's average score changed by −9.3 points from the start, while the placebo group's average score changed by −1.9 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00267969 · results posted 24 August 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 766 adults with psoriasis across three starting groups during the first phase: 255 received a placebo (a dummy treatment with no active ingredient), 255 received a lower dose of ustekinumab (45 mg), and 256 received a higher dose (90 mg). The trial was measuring changes in psoriasis severity using two main tools: the PASI score, which rates the redness, scaling, thickness and spread of psoriasis on a scale from 0 (clear skin) to 72 (most severe); and the Physician Global Assessment (PGA), where a doctor rates overall skin appearance from 0 (cleared) to 5 (severe). A quality-of-life questionnaire was also used. After the first 12-week phase, participants moved into a longer follow-up period lasting until week 52. The reported data shows that at the 12-week mark, 8 out of 255 participants in the placebo group achieved at least a 75% improvement in their PASI score, compared with 171 out of 255 in the 45 mg group and 170 out of 256 in the 90 mg group. For the doctor's overall skin rating, 10 placebo participants reached a score of "cleared" or "minimal," compared with 151 in the 45 mg group and 156 in the 90 mg group. On the quality-of-life questionnaire (scored 0–30, where lower is better), the placebo group's average score did not change from the start, while the 45 mg group's average score fell by 6 points and the 90 mg group's by 7 points — meaning those participants reported less impact on daily life, on average. The reported data also shows results at week 52 for participants who had been re-assigned at week 40 — some continuing on regular doses and others having their treatment withdrawn. Among those who had their 45 mg treatment withdrawn, 47 still met the 75% improvement threshold, compared with 67 who continued receiving the 45 mg dose every 12 weeks. In the 90 mg groups, 53 in the withdrawal group and 77 in the continuing group met that threshold. When the two withdrawal groups were combined, 100 participants still met the threshold, compared with 144 in the combined continuing-treatment group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00833053 · results posted 26 July 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 39 adults with psoriasis — a skin condition — across two groups. Nineteen participants received infliximab (a medication given by drip) every six weeks, while 20 received infliximab every eight weeks combined with methotrexate (another medication taken separately). The trial was measuring how well each approach reduced the severity of psoriasis skin lesions over 28 weeks, using a scoring system called the PASI (Psoriasis Area and Severity Index), which rates redness, thickness, and scaliness of patches on a scale where higher numbers mean more severe disease. The reported data shows that the main result the trial was designed to measure was how many participants achieved a 75% reduction in their PASI score by week 28 — known as a "PASI-75 response." In the group receiving infliximab every six weeks, 9 out of 19 participants reached this level of reduction. In the group receiving infliximab every eight weeks plus methotrexate, 11 out of 20 participants reached it. It is also worth noting that 9 participants in the first group did not complete the study, compared with 3 in the second group. For all of the secondary outcomes — including 50%, 90%, and 100% reductions in PASI score, overall change in PASI score, and a quality-of-life questionnaire — the reported data shows no numbers were submitted to ClinicalTrials.gov, so those results are not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00936065 · results posted 9 April 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people across three groups: 21 received etanercept (an injection-based medicine) alone, 20 received etanercept combined with acitretin (a tablet), and 19 received acitretin alone. The trial was measuring changes in psoriasis severity over 24 weeks using a standard skin scoring system called the PASI, which runs from 0 (no disease) to 72 (worst possible). Doctors also rated participants' overall skin condition using a separate scale called the Physician Global Assessment (PGA). Not everyone completed the trial — 17, 16, and 12 participants finished in each group respectively. The reported data shows that by week 24, around 52% of participants in the etanercept-only group, 58% in the combination group, and 22% in the acitretin-only group had reached the primary target — a 75% improvement in their PASI skin score. For the secondary target of a 50% improvement in PASI score, the reported figures at week 24 were approximately 76% for etanercept alone, 79% for the combination, and 22% for acitretin alone. The reported data also shows that the median time to reach a 50% improvement in skin score was 56 days for both etanercept groups and 126 days for the acitretin-only group. On the doctors' overall skin rating at week 24, about 29% of the etanercept group, 21% of the combination group, and 6% of the acitretin group were rated as "clear or almost clear," and no participants in any group were rated as fully "clear" by the end of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01139580 · results posted 23 September 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 363 adults with scalp psoriasis — 181 received a calcipotriene (an active ingredient) foam and 182 received a vehicle foam (a foam without the active ingredient, used as a comparison). By the end of the study, 158 people in the calcipotriene group and 164 in the vehicle group had completed the trial. The main thing being measured was how many participants had their scalp psoriasis rated as "clear" or "almost clear" by a doctor after 8 weeks, using a standardised scoring system where 0 means no disease and 5 means very severe disease. The reported data shows that, at week 8, 74 out of 181 participants in the calcipotriene foam group and 44 out of 182 in the vehicle foam group had their scalp rated as clear or almost clear (using one counting method); a second counting method — which used each participant's last available score if they left the study early — produced very similar numbers: 75 versus 45. For the secondary measures, which looked at specific features of psoriasis patches on a target area of skin: 42 calcipotriene participants versus 30 vehicle participants showed a score of 0 or 1 for skin redness (with at least a 2-grade improvement from the start); 53 versus 38 showed a score of 0 or 1 for skin flaking (also with at least a 2-grade improvement); and 67 versus 53 showed a score of 0 or 1 for skin thickness. For body psoriasis (not scalp), the reported data shows 32 versus 28 participants (or 33 versus 28 in a second count) reached a clear or almost clear rating, though the distinction between these two counts was not fully detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00438360 · results posted 9 August 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 162 people in the Cyclosporine A group and 81 people in the placebo (inactive treatment) group, for a total of 243 participants. The trial was studying psoriasis — a skin condition — and was measuring whether an intermittent (stop-start) dosing approach with Cyclosporine A could prevent or delay the return of psoriasis symptoms (called a "relapse") compared to a placebo. The main tool used to measure symptom severity was a scoring system called the PASI (Psoriasis Area and Severity Index), where a score of 0 means no symptoms and 72 means the most severe possible. A relapse was counted if a participant's PASI score rose back to 75% or more of what it was before the study began. The reported data shows that, for the primary outcome — whether participants relapsed or not — 73 out of 160 participants in the Cyclosporine A group were recorded as having a relapse, compared to 43 out of 79 in the placebo group. For the secondary outcomes, the reported proportion of participants experiencing a clinical relapse was 0.369 (roughly 37%) in the Cyclosporine A group and 0.456 (roughly 46%) in the placebo group. The reported change in PASI scores from the start of the study was 5.70 points in the Cyclosporine A group and 6.86 points in the placebo group. The reported change in body surface area affected by psoriasis was 8.12 m² in the Cyclosporine A group and 10.45 m² in the placebo group. For itchiness (pruritus), measured on a 0–100 scale where higher means more itch, the reported change from baseline was 17.32 in the Cyclosporine A group and 25.44 in the placebo group. The safety and tolerability data was listed as a reported outcome but no numerical results were included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01083693 · results posted 26 July 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 161 people across three groups: 93 with Rheumatoid Arthritis (RA), 28 with Psoriatic Arthritis (PsA), and 40 with Ankylosing Spondylitis (AS). The study was measuring changes in participants' ability to carry out everyday tasks, their overall quality of life, and their levels of disease activity over time, using several recognised questionnaire-based scoring tools. Of the 161 who started, 128 completed the study (73 with RA, 22 with PsA, and 33 with AS). The reported data shows the following across the measurement tools used. On the HAQ-DI — a daily-functioning questionnaire scored from 0 (no difficulty) to 3 (unable to do) — the RA group started at an average of 1.2 and was recorded at 0.8 by the later time points; the PsA group started at 0.9 and reached 0.3–0.4. On the SF-36 quality-of-life survey (scored 0–100, higher is better), overall physical scores across all three groups started at around 53 and rose to around 71 by a later time point; mental/emotional scores followed a similar upward pattern. The EQ-5D general health score (ranging from −0.59 to +1) started at around 0.4–0.5 across groups and was reported at around 0.7–0.8 at later points. For disease activity, the DAS28 score (used for RA and PsA, scale 0–10, lower is better) started at roughly 5.3–5.4 for RA and fell to around 3.4–3.7 across time points; for AS patients, the BASDAI score (also 0–10, lower is better) started at 6.0 and was reported as low as 2.0 at one time point, though the data did not specify clearly which values corresponded to which time points beyond the starting figure. Physician and patient global assessments (scale 0–100, lower is better) for RA and PsA participants started at around 52–55 and were reported at around 17–30 at later time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00658606 · results posted 22 April 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 49 people in each of two groups — one group received a medicine called alefacept on its own, and the other received alefacept combined with a type of ultraviolet light therapy known as narrowband UVB (nbUVB). The trial was measuring how much participants' psoriasis improved, using two scoring tools: the PASI score (which rates redness, scaling, and skin thickness on a scale from 0 to 72, where higher means worse) and the PGA scale (an overall severity rating from 0 meaning clear skin to 5 meaning very severe). The main goal was to see how many participants reached a 75% or greater improvement in their PASI score by week 16 of the study. The reported data shows that by week 16, around 22% of participants in the alefacept-alone group reached that 75% improvement threshold, compared with around 45% in the combined treatment group. Looking across the full course of the study, those figures were approximately 27% and 37% respectively. For body surface area covered by psoriasis, the reported data shows the alefacept-alone group started at roughly 22% of the body affected and saw a reduction of about 8 percentage points by week 16, while the combined group started at about 20% and saw a reduction of around 13 percentage points. When it came to the PGA rating of "clear" or "almost clear" skin by week 16, approximately 23% of the alefacept-alone group and 43% of the combined group were reported to have reached that level. Over the entire study, those figures rose to approximately 35% and 59% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00845481 · results posted 8 March 2011
According to the results reported on ClinicalTrials.gov, 24 people with psoriasis took part in this trial, and all 24 completed it. The trial used a method where each participant had several different patches of skin treated with different ointments at the same time — allowing multiple treatments to be compared within the same person. The main thing being measured was how much each ointment changed a "Total Clinical Score" (TCS), which is a combined score of skin redness, thickness, and scaliness, rated from 0 (clear skin) to 9 (worst possible). The reported data shows that all six ointments were associated with a reduction in the Total Clinical Score from the start of the trial to the end of treatment, though by different amounts. Dermovat ointment was associated with the largest reported drop (−5.71 points), followed by Daivobet ointment (−5.15 points), then Elocon ointment and Diprosalic ointment (both −4.50 points), then Betnovate ointment (−3.33 points). The vehicle ointment — a base cream with no active ingredient, used as a comparison — was associated with the smallest reported drop (−1.91 points). No secondary outcome measure data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00686595 · results posted 24 February 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 38 people who all received infliximab at a dose of 5 mg/kg. Thirty-one participants completed the study, while seven did not finish. The trial was looking at changes in psoriasis symptoms over time using a scoring system called the PASI (Psoriasis Area and Severity Index). This score is based on a doctor's assessment of how red, thick, and scaly the skin patches are, and how much of the body is affected — with scores ranging from 0 (no disease) to 72 (most severe). The trial tracked the proportion of participants whose PASI score dropped by at least 75% (called a "PASI 75 response") or at least 50% ("PASI 50 response") compared to where they started, at three different points in time: week 10, week 18, and week 24. The reported data shows the following results for the PASI 75 measure (at least 75% reduction in score from the start): 71% of participants reached this level by week 10, 94% by week 18, and 74% by week 24. For the PASI 50 measure (at least 50% reduction), the reported figures were 91% of participants at week 10, 97% at week 18, and 89% at week 24. These percentages reflect the proportion of the study group who reached each threshold at each time point, as recorded by the researchers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00881868 · results posted 23 December 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 81 people with scalp psoriasis — 41 in the Clobex Spray group and 40 in the Vehicle Spray group (a "vehicle spray" is an inactive spray containing no active ingredient, used for comparison). By the end of the study, 33 people in the Clobex Spray group and 38 in the Vehicle Spray group had completed the trial. The trial was measuring how participants' scalp psoriasis changed over up to four weeks, looking at an overall severity score, as well as individual signs like scaling, redness, plaque thickness, itching, and how much of the scalp was affected. The reported data shows that for the main outcome — whether a participant's overall scalp severity score reached "clear" or "almost clear" by the end of treatment — 35 out of 41 participants in the Clobex Spray group were counted as a success, compared with 5 out of 40 in the Vehicle Spray group. The remaining 6 in the Clobex Spray group and 35 in the Vehicle Spray group did not reach that threshold. For the secondary measures, the reported data shows that at the end of the study, more participants in the Clobex Spray group were rated at lower (better) scores for scaling, redness, and plaque elevation compared with the Vehicle Spray group, though exact category-by-category figures were reported across multiple scoring levels. Similarly, for itching, more Clobex Spray participants were recorded at the "none" or "mild" end of the scale at week 4. For scalp coverage, more Clobex Spray participants fell into the lower (smaller area affected) categories by the end of treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00195676 · results posted 19 November 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,468 people being treated for psoriasis (a skin condition causing patches of inflamed, scaly skin). The trial was designed across several phases: an open treatment phase where everyone received adalimumab (a medication given by injection), a withdrawal phase where treatment was stopped, and a re-treatment phase lasting 16 weeks. The main thing the trial was measuring was how many participants had their skin condition rated as "clear" or "minimal" by their doctor after 16 weeks of re-treatment, using a standard doctor-scored scale from 0 (clear) to 5 (very severe). The reported data shows that in the re-treatment phase, 76.5% of participants had their skin rated as "clear" or "minimal" by their doctor at the 16-week mark. During the longer open treatment phase, the reported data shows that 50.6% of participants reached that "clear" or "minimal" rating at around 60 weeks, and 46.3% at around 120 weeks. Separately, a commonly used psoriasis scoring tool (which measures the area and severity of skin involvement on a scale, with a higher score meaning more severe disease) showed that 61.4% of participants had at least a 75% reduction in their score by week 60, and 57.3% by week 120. For the withdrawal phase, the reported data shows that the middle point at which participants' skin condition returned to a moderate-or-worse rating was around 141 days (roughly 4.5 months) after stopping treatment. It is worth noting that all 608 participants recorded as "not completing" the withdrawal phase did so because their condition returned and they moved into the re-treatment phase — this appears to be by design rather than due to dropping out. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00927069 · results posted 24 August 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 85 participants in total — 50 in Group A and 35 in Group B — all of whom had plaque psoriasis and had not responded well enough to at least three months of treatment with another medicine called etanercept. The trial was measuring how participants' skin was rated by a doctor using a scale called the Physician's Global Assessment (PGA), which grades skin from "clear" (no raised plaques) through to more severe appearances. The trial ran in two phases: the first 12 weeks, and then a further 12 weeks (up to week 24) during which some participants who had not responded well enough had their dose increased. The reported data shows that by week 12, 11 out of 35 participants in Group B and 17 out of 50 participants in Group A were rated by their doctor as "clear" or "almost clear." After week 12, participants who had not reached that level had their dosing frequency increased, and a second round of measurements was taken at week 24. The reported data shows that of those who received a dose increase from Group B, 7 out of 23 reached a "clear" or "almost clear" rating by week 24, while 10 out of 31 from Group A who received a dose increase also reached that rating by week 24. The trial also recorded the total number of adverse events (unwanted health occurrences noted during the study) — 91 were reported in Group A and 63 in Group B — though no further breakdown of those events was included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00527072 · results posted 24 June 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 215 people, all of whom received the medication infliximab. Of those, 179 people completed the study, while 36 did not finish. The trial was measuring how well infliximab reduced the severity of psoriasis symptoms, using two main tools: a doctor's overall impression score (called the Physician Global Assessment, or PGA) and a detailed skin scoring system (called the PASI, which rates the severity and extent of psoriatic skin patches on a scale from 0 to 72, where higher numbers mean more severe disease). The reported data shows that, at the 10-week mark, 138 out of 215 participants were recorded as having a PGA score of either "clear" (0) or "minimal" (1) — meaning the treating doctor rated their skin as showing little to no signs of psoriasis at that point. For the PASI measure, the trial tracked how many people achieved at least a 50% improvement in their skin score from where they started. The reported data shows that 167 out of 215 participants reached that 50% improvement mark by week 10, and 135 out of 215 participants were still recorded as having that level of improvement at week 26. It is worth noting that participants who dropped out or stopped treatment early before week 10 were counted as not having improved, which is a standard way of handling missing data in this type of trial. The reported figures reflect those counting rules as set out by the trial organisers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01079988 · results posted 11 May 2010
According to the results reported on ClinicalTrials.gov, a total of 41 people took part in this clinical trial across five treatment groups: cyclosporin (10 people), retinoids (1 person), systemic corticosteroids (8 people), methotrexate (20 people), and a combination of systemic corticosteroids and methotrexate (2 people). The trial was measuring how doctors and patients themselves rated changes in psoriasis over time. The reported data shows that the main (primary) outcome measured how doctors rated each participant's overall change in psoriasis, using categories ranging from "cleared" (complete or near-complete improvement) down to lesser degrees of improvement. A rating of "good or better" meant the doctor observed at least 50% improvement compared to the start of the trial. In the cyclosporin group, 7 out of 10 participants were rated as "good or better" by their doctor. In the methotrexate group, 9 out of 20 participants received this rating. In the systemic corticosteroids group, 2 out of 8 were rated "good or better." For the retinoids group and the combination group, the reported number was 0 — though it is worth noting these groups had very few participants (1 and 2 respectively). The reported data also shows a secondary outcome, where participants rated their own psoriasis on a scale from 0 (no psoriasis) to 10 (worst imaginable psoriasis). At the end of the study, the average self-reported scores were: cyclosporin group 5.1, retinoids group 4.0, systemic corticosteroids group 5.5, methotrexate group 4.8, and the combination group 4.5. These are simply the numbers participants reported — no comparison between groups was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00647400 · results posted 11 January 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 147 people with psoriasis — 89 in a group receiving adalimumab at a dose of 40 mg every other week, and 58 in a group receiving 80 mg every other week. The trial was an extension study that continued on from an earlier trial, and it tracked how participants' psoriasis skin scores changed over time. The main thing being measured was a scoring system called PASI (Psoriasis Area and Severity Index), which runs from 0 (clearest skin) to 72 (most severe), and the trial counted how many participants reached certain levels of score reduction compared to where they started. By the end of the study, 67 people in the 40 mg group and 45 in the 80 mg group had completed it. The reported data shows that for the primary measure — the number of participants whose PASI score dropped by at least 50% from their starting point — the numbers across multiple time points ranged from 75 to 80 participants (out of 89) in the 40 mg group, and from 49 to 55 participants (out of 58) in the 80 mg group. For the first secondary measure, a 75% or greater reduction in PASI score, the reported data shows figures ranging from 54 to 70 participants in the 40 mg group and 43 to 51 in the 80 mg group across the various time points recorded. For the second secondary measure, a 90% or greater reduction in PASI score, the numbers ranged from 31 to 55 participants in the 40 mg group and 29 to 44 in the 80 mg group across those same time points. It is worth noting that the data as submitted does not label which specific time points each set of numbers corresponds to, so the exact timing of each measurement cannot be confirmed from the information provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00733954 · results posted 20 August 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 249 people with plaque psoriasis — 124 in a group using a clobetasol propionate spray and 125 in a group using a clobetasol propionate ointment. Of those, 116 and 123 participants respectively completed the study. The trial was measuring how many people in each group reached a rating of "clear or almost clear" on a skin severity scale, at different time points: the spray group was assessed after four weeks of treatment, while the ointment group was assessed after two weeks. The reported data shows the following numbers for the main (primary) outcome — participants rated "clear or almost clear" by the end of their treatment period: 62 out of 124 in the spray group, and 44 out of 125 in the ointment group. For a secondary check at the two-week mark (mid-point for the spray group, end-point for the ointment group), the reported numbers were 39 for the spray group and 44 for the ointment group. At a follow-up check two weeks after treatment finished, 50 spray-group participants and 33 ointment-group participants were reported as clear or almost clear. The trial also tracked three individual skin signs — redness (erythema), flaking (scaling), and skin thickening (plaque elevation) — at the two-week mark. The reported data shows that for redness, 29 spray and 33 ointment participants reached clear or almost clear; for flaking, 53 spray and 72 ointment participants; and for skin thickening, 48 spray and 52 ointment participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00245960 · results posted 27 May 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 752 people with psoriasis across two groups. One group (379 people) received etanercept twice a week for the first 12 weeks, then once a week for the next 12 weeks — called the "BIW/QW" group. The other group (373 people) received etanercept once a week throughout the entire 24-week trial — called the "QW/QW" group. The trial was measuring how participants' skin and joint symptoms were assessed by their doctors over time, using standardised rating scales. The reported data shows that for the primary outcome — the number of people whose skin was rated as "clear" or "almost clear" by their doctor at the end of the first 12-week period — 176 out of 379 people in the BIW/QW group and 119 out of 373 people in the QW/QW group received that rating. For a secondary outcome looking at joint symptoms (called the Psoriatic Arthritis Response Criteria, or PsARC — a measure based on changes in swollen joints, tender joints, and overall disease activity ratings), the reported data shows that at week 12, 284 participants in the BIW/QW group and 282 in the QW/QW group met this response measure; by week 24, those numbers were 303 and 299 respectively. It is worth noting that some outcome data details, including exact timepoints for all measurements, were not fully separated in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
See the full Psoriasis page · What changed recently
Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.