Reported trial results for Eczema
Every Eczema 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.
129 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
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NCT05633355 · results posted 24 July 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05633355) enrolled 187 participants, all of whom received a treatment called rocatinlimab. Of those, 160 people completed the study and 27 did not finish. The trial had one primary outcome measure, which focused on tracking serious unwanted medical events — called treatment-emergent serious adverse events (TESAEs) — meaning significant medical occurrences (such as those requiring hospitalisation, that were life-threatening, or that caused lasting disability) that happened after participants received their first dose. The reported data shows that out of 187 participants, 4 people experienced a treatment-emergent serious adverse event during the study period. No other outcome measures were included in the structured data submitted to ClinicalTrials.gov for this trial, so no additional figures are available to report 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 ↗
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NCT05990725 · results posted 17 July 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 260 people who received the treatment lebrikizumab for eczema (also called atopic dermatitis). Of those, 247 were included in the main analysis group and 243 completed the study. The trial was measuring how well different scoring tools — which rate things like skin redness, thickness, and the area of skin affected — changed over 24 weeks of treatment. There was no comparison (control) group reported in these results, so all figures relate only to the people who received lebrikizumab. The reported data shows that by Week 24, 74.7% of participants reached a score of 7 or below on the EASI scale (a skin severity score that runs from 0 to 72, where lower is less severe). Looking at earlier time points, the proportion reaching that same threshold grew over the weeks — from 13.4% at the first measured visit, to 35.9%, and then 70.6% before the final reading. For a stricter target — a 75% reduction from each person's starting EASI score — the reported figures were 7.7% at the earliest visit, rising to 63.5% by Week 24. For an even stricter 90% reduction, the figures went from 1.2% up to 34.1% by Week 24. A separate doctor-rated scale (IGA, scored 0–4) showed 41.3% of participants reaching a score of 0 or 1 (clear or almost clear skin) with at least a 2-point drop from their starting score by Week 24. The reported data also shows results from two other scoring tools. On the SCORAD scale (which also factors in itch and sleep disruption), a 75% reduction from starting scores was reported in 20.4% of participants by Week 24, while a 90% reduction was reported in 3.4%. For a hand-specific eczema score (mTLSS), the reported percentage change from the starting point moved from a small increase early on, to a reduction of around 66% by Week 24 — noting that the data was not reported in a way that allows a breakdown of what this means for individual 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.
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NCT05018806 · results posted 13 July 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05018806) looked at a medicine called rilzabrutinib in people with atopic dermatitis (eczema). A total of 124 people took part across four groups. Participants either received a placebo (a dummy treatment with no active medicine) or rilzabrutinib taken either twice a day (the "BID" group) or three times a day (the "TID" group). The main thing being measured was the change in eczema severity — using a scoring system called the EASI, which rates things like redness, skin thickness, scratching marks, and how much of the body is affected, on a scale from 0 (clear) to 72 (most severe) — after 16 weeks. The reported data shows that for the main outcome (percentage change in EASI score from the start to week 16), all four groups saw reductions in their scores. The placebo group taking twice-daily doses saw a reported reduction of around 47%, while the rilzabrutinib twice-daily group saw a reduction of around 54%. In the three-times-daily comparison, the placebo group saw a reduction of around 43% and the rilzabrutinib group around 47%. For the secondary outcomes, the reported data shows that when looking at the proportion of participants whose skin was rated "clear" or "almost clear" by a doctor at week 16, the figures were: 22% (twice-daily placebo), 7% (twice-daily rilzabrutinib), 13% (three-times-daily placebo), and 15% (three-times-daily rilzabrutinib). The proportion of participants who achieved a 75% or greater reduction in their EASI score was reported as 28% (twice-daily placebo), 30% (twice-daily rilzabrutinib), 29% (three-times-daily placebo), and 19% (three-times-daily rilzabrutinib). Regarding itch — measured on a 0–10 self-rated scale — the percentage of participants who reported a meaningful reduction in their worst daily itch score (a drop of 4 or more points) at week 16 was 11% (twice-daily placebo), 19% (twice-daily rilzabrutinib), 13% (three-times-daily placebo), and 21% (three-times-daily rilzabrutinib). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05651711 · results posted 26 June 2026
According to the results reported on ClinicalTrials.gov, this trial compared two groups of adults with atopic dermatitis (eczema): 183 people received a placebo (an inactive treatment) and 543 people received a medicine called rocatinlimab at a dose of 300 mg given once every four weeks. The trial measured changes in skin inflammation, overall skin appearance, itching, and skin pain at various points over the study period, using standardised scoring tools rated by doctors and participants themselves. The reported data shows that at 16 weeks, 159 out of 543 participants in the rocatinlimab group had their skin inflammation score reduce by at least 75% (a measure called EASI 75), compared with 23 out of 183 in the placebo group. For overall skin appearance, 69 rocatinlimab participants (out of 543) reached a rating of "clear" or "almost clear" skin, compared with 5 out of 183 in the placebo group. Regarding itch at week 16, 110 rocatinlimab participants (out of those who started with significant itch) reported at least a 4-point drop in their worst daily itch score (on a 0–10 scale), versus 18 in the placebo group. The reported data also shows results at 24 weeks. For itch relief, 121 rocatinlimab participants reported at least a 4-point reduction in their worst itch score, compared with 17 in the placebo group. For a very high level of skin improvement (at least 90% reduction in the inflammation score), 108 rocatinlimab participants met this threshold versus 9 in the placebo group. For skin pain, 109 rocatinlimab participants (among those with significant baseline pain) reported at least a 4-point drop in their skin pain score, compared with 14 in the placebo group. Note that no primary 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT06238817 · results posted 22 May 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 241 participants across two main groups: 81 people received a vehicle cream (an inactive cream with no active ingredient, used as a comparison) and 160 people received ruxolitinib 1.5% cream (the treatment being studied). The trial was measuring changes in eczema (atopic dermatitis) severity over 8 weeks, using two main scoring tools — one called EASI, which rates the physical signs of eczema on a scale of 0 to 72, and another called IGA, which gives an overall severity rating from 0 (clear) to 4 (severe). The reported data shows that at the 8-week mark, 70.0% of participants in the ruxolitinib cream group had their EASI score improve by 75% or more from where it started, compared with 18.5% of participants in the vehicle cream group. For the IGA measure, 61.3% of those using ruxolitinib cream achieved a score of 0 or 1 (meaning clear or almost clear skin) with at least a 2-grade improvement from their starting score, compared with 13.6% in the vehicle cream group. The reported data for the secondary outcome measures — including itch scores and adverse event (side effect) counts — was not provided in the data 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 ↗
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NCT05590585 · results posted 2 January 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05590585) enrolled 124 participants, all of whom received at least one dose of dupilumab, a medication being studied for atopic dermatitis (eczema). One hundred and twenty participants completed the study, while four did not. There was no comparison group — everyone in the trial received the same treatment. The trial tracked several measures of eczema severity over time, including a doctor's overall rating of skin condition (called the IGA score) and a detailed scoring system that looks at the area and severity of eczema across the body (called the EASI score). The reported data shows that, on the IGA scale — where 0 means the skin is clear and 4 means severe — the percentage of participants rated as "clear" or "almost clear" started at 0.9% and rose to 45.4% at the second-to-last check-in, before sitting at 44.0% at the final measurement. For the EASI score — which runs from 0 (no eczema) to 72 (most severe) — the reported data shows an average reduction from the starting score of about 7 points after the first check-in, growing to a reduction of around 21 points by the end of the study. Expressed as a percentage change, this represents roughly a 26% reduction early on, rising to nearly 80% by the final visits. The reported data also shows that by the last measurement point, around 89% of participants had seen their EASI score drop by at least 50% from their starting point, about 76% had seen at least a 75% drop, and approximately 42% had seen at least a 90% drop. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05250115 · results posted 29 September 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05250115) enrolled 110 people with atopic dermatitis (eczema) who all received a medicine called abrocitinib. Of those 110 participants, 41 completed the study and 69 did not complete it. The trial was measuring how participants' eczema severity changed over time using two main tools: a doctor's overall rating scale (called the IGA, scored 0–4, where lower is better) and a more detailed scoring system that looks at how much of the body is affected and how severe the signs are (called EASI, scored 0–72, where lower is better). The reported data shows that at the three-month mark — the main point of interest — about 35.7% of participants had their eczema rated as "clear" or "almost clear" by their doctor on the IGA scale, and about 47.6% had their detailed EASI score drop by at least 75% compared to where they started. When looking across the entire length of the study (not just the three-month point), the reported data shows that approximately 51.5% of participants reached a "clear" or "almost clear" doctor rating at some point, around 47.5% achieved that rating alongside at least a 2-point drop from their starting score, about 63.4% had their EASI score fall by at least 75% from their starting level, and roughly 42.6% had their EASI score fall by at least 90% from their starting level. It is worth noting that a large proportion of participants — 69 out of 110 — did not finish the study, which the reported data does not fully explain. No comparison group (such as a placebo or different treatment) was included, so the figures above reflect only the one group that received abrocitinib. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04392154 · results posted 3 August 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04392154) looked at a medicine called lebrikizumab in people with atopic dermatitis (eczema). During the main part of the trial, which ran for 100 weeks, 141 participants received the medicine once every four weeks (Q4W) and 1,012 participants received it once every two weeks (Q2W). A separate 32-week extension phase then followed for a smaller group of 103 participants, split roughly evenly between a once-every-four-weeks group and a once-every-eight-weeks group. The trial measured several things, including how many people stopped taking the medicine because of unwanted side effects, as well as two standard eczema scoring tools used by doctors to assess skin appearance and the area of skin affected. The reported data shows the following numbers from the main 100-week period. For the primary outcome — the proportion of participants who stopped the medicine due to adverse events (unwanted health effects) — 2.1% in the Q4W group and 4.5% in the Q2W group did so. For one secondary outcome, a doctor's rating scale called the IGA (scored 0 to 4, where 0 means clear skin), 80.1% of the Q4W group and 60.6% of the Q2W group were reported to have achieved a score of 0 or 1 (meaning clear or nearly clear skin) at week 100. For another secondary outcome using a different scoring tool called EASI-75 — which measures whether a participant's eczema severity score improved by at least 75% — 90.4% of the Q4W group and 79.4% of the Q2W group were reported to have reached that level of improvement at week 100. Completion rates and outcome numbers for the extension phase were not reported in the submitted data beyond 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 ↗
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NCT05507580 · results posted 29 July 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 461 participants with atopic dermatitis (eczema) across two groups during the first phase: 229 received a 15 mg dose of upadacitinib (UPA) and 232 received a 30 mg dose, both without participants knowing which dose they were taking. After this first 12-week phase, participants moved into a second phase where they could be switched to a different dose or stay on the same one, creating four subgroups. The trial used a standard eczema scoring tool called the EASI (scored from 0 to 72, where higher numbers mean more severe eczema) to track changes in skin symptoms over time. The reported data shows that at 12 weeks, 64.4% of those on the 15 mg dose and 79.3% on the 30 mg dose had their EASI score reduced by at least 75% from where it started. For a 90% or greater reduction at 12 weeks, the figures were 33.8% (15 mg) and 59.9% (30 mg); and for a complete 100% reduction, 7.7% (15 mg) and 15.9% (30 mg) were reported. By week 24, the reported data shows results varied depending on which dose participants received across both phases. Among those who were on the 15 mg dose throughout both phases, 74.6% had at least a 90% reduction in their EASI score, compared to 29.3% for those on 30 mg throughout. For participants who switched doses between phases, the reported figures fell between these values. Complete clearance (100% reduction) at week 24 ranged from 3.7% to 33.8% depending on the dose pathway followed. 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 ↗
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NCT05131477 · results posted 3 July 2025
According to the results reported on ClinicalTrials.gov, this trial tested a drug called KY1005 in people with atopic dermatitis (eczema). The trial had two parts. In Part 1, around 390 participants were randomly assigned to receive one of four different doses of KY1005 or a placebo (a dummy treatment with no active ingredient) for 24 weeks. Participants who responded well during Part 1 were then re-randomised into Part 2, where they either continued on KY1005 or were switched to placebo for a further period. The trial used a standard eczema severity scoring tool called the EASI (which runs from 0 to 72, with higher numbers meaning more severe eczema) as its main measure, along with several other measures including a doctor's overall rating of skin condition and a participant-rated itch score. The reported data shows that at 16 weeks (the main measurement point in Part 1), EASI scores had fallen by between approximately 52% and 62% across the KY1005 dose groups, compared with around 29% in the placebo group. By week 24, the reported reductions in EASI scores were similar, ranging from roughly 52% to 64% for the KY1005 groups versus about 28% for placebo. For the secondary measure looking at participants whose eczema score dropped by at least 75% (known as "EASI 75"), the reported data shows that at week 16, between approximately 38% and 43% of participants in the KY1005 groups reached this threshold, compared with around 11% in the placebo group; at week 24 those figures were roughly 38% to 55% versus about 18%. For the doctor's overall skin assessment (IGA), the percentage of participants rated as "clear" or "almost clear" at week 16 ranged from about 14% to 25% across the KY1005 groups versus around 5% for placebo, and at week 24 from about 29% to 46% versus about 11%. For self-reported itch scores in Part 2, the data for some sub-groups was not fully reported in the structured results 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 ↗
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NCT05355818 · results posted 2 July 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05355818) looked at a cream called delgocitinib as a treatment for chronic hand eczema. A total of 98 people took part — 74 were assigned to use the delgocitinib cream and 24 were assigned to use a "vehicle" cream (a cream with no active ingredient, used as a comparison). Of those, 71 and 21 people respectively completed the study. The trial ran for 16 weeks and used several rating tools to measure changes in the appearance and feel of participants' hand eczema. The reported data shows the following numbers at week 16. For the main (primary) measure — a doctor's overall rating of hand eczema severity — 47 out of 74 participants in the delgocitinib group and 7 out of 24 in the comparison cream group reached the threshold called "treatment success" (meaning their skin was rated clear or almost clear, with a meaningful improvement from the start). For a separate skin-severity scoring tool, 53 participants in the delgocitinib group and 9 in the comparison group showed at least a 90% improvement in their score from the start. When it came to itch measured by a participant-completed diary, 35 people in the delgocitinib group and 7 in the comparison group reported a reduction of 4 or more points (on a 0–10 scale) from their starting score. For pain, those numbers were 31 and 5 respectively. An overall symptom diary score showed 30 and 5 participants reaching that same 4-point reduction. At the earlier two-week check, 16 participants in the delgocitinib group and 1 in the comparison group had already met the doctor's "treatment success" 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05372653 · results posted 30 March 2025
According to the results reported on ClinicalTrials.gov, this trial looked at two different strengths of a cream called OPA-15406 — a 0.3% strength and a 1% strength — in people with a skin condition (likely eczema, based on the measures used). A total of 41 people started the trial: 12 in the lower-strength group and 29 in the higher-strength group. Of those, 11 and 25 respectively completed the study. The trial measured how participants' skin symptoms changed over four weeks, using two scoring systems — one called the IGA (a researcher's overall rating of skin severity) and one called the EASI (which scores the area and severity of the skin condition). The reported data shows results only for the 0.3% OPA-15406 group — no outcome numbers for the 1% group were included in the data submitted. For the primary measure (IGA success rate), 56.1% of participants in the 0.3% group had their skin rated as "clear" or "almost clear" by the researcher at Week 4, with an improvement of at least two steps from their starting score. For the secondary measure (EASI-75), 82.93% of participants in the 0.3% group showed at least a 75% improvement in their EASI skin score from the start of the trial. Outcome figures for the 1% strength group 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 ↗
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NCT05579899 · results posted 5 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05579899) looked at a skin cream called EVO101 compared to a "vehicle cream" (a cream with no active ingredient, sometimes called a placebo cream) in people with atopic dermatitis, commonly known as eczema. A total of 60 people were assigned to the EVO101 cream group and 59 to the vehicle cream group. The trial ran for 8 weeks and measured things like the area and severity of eczema, how much of the body was affected, and how itchy participants felt. The reported data shows that for the main measure — a scoring system called the EASI (which rates eczema severity on a scale from 0 to 72, with higher scores meaning worse eczema) — the EVO101 group's scores fell by an average of 43.5% from their starting point, while the vehicle cream group's scores fell by an average of 62.0% over the 8 weeks. For a separate doctor-rated assessment of overall eczema appearance (rated 0 to 4), the reported data shows 20 participants in the EVO101 group and 23 in the vehicle group achieved an improvement of 2 or more points, though the data as submitted also includes a second set of figures (37 and 28 respectively) whose context was not clearly specified in the structured results. The reported data also shows that the percentage of body surface area affected by eczema decreased by an average of 2.1 percentage points in the EVO101 group and 3.5 percentage points in the vehicle group. For itch severity — rated by participants on a scale of 0 ("no itch") to 10 ("worst itch imaginable") — the EVO101 group reported an average reduction of 2.5 points, compared to 3.5 points in the vehicle cream 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.
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NCT05601882 · results posted 14 February 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 920 adults with atopic dermatitis (eczema) across two treatment groups in the first phase: 462 people received dupilumab and 458 received upadacitinib. The trial was designed in two back-to-back periods running from the start to Week 16, and then from Week 16 to Week 32, with some participants switching or continuing treatment in the second period. The main thing the trial was measuring was how many people, by Week 16, achieved both a 90% or greater reduction in a standard eczema severity score (called EASI, which rates skin redness, thickness, scratching marks, and skin hardening on a scale of 0 to 72) and also reported their worst itch as zero or one out of ten on a rating scale. The reported data shows that for the primary measure at Week 16 — achieving both the near-complete skin clearance and near-zero itch score together — 8.9% of participants in the dupilumab group and 19.9% in the upadacitinib group reached that combined goal. Looking at skin clearance alone (the 90% reduction in the EASI score), the reported figures were 22.5% for dupilumab and 40.8% for upadacitinib. For itch specifically, 15.5% of the dupilumab group and 30.2% of the upadacitinib group reported their worst itch dropping to nearly none (a score of 0 or 1) by Week 16. Earlier in the trial, at Week 4, those itch figures were 2.8% and 16.1% respectively, and at Week 2 they were 1.3% and 7.7%. The reported data also shows that 38.1% of dupilumab participants and 54.7% of upadacitinib participants who started with moderate-to-severe itch saw their itch score drop by at least 4 points by Week 16. 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 ↗
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NCT04949841 · results posted 20 January 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 801 people with chronic hand eczema (a persistent, inflammatory skin condition affecting the hands) who used a cream called delgocitinib on an as-needed basis — meaning they applied it when they felt they needed it rather than on a fixed schedule. Of those 801 participants, 664 completed the study, while 137 did not. The trial tracked a range of measurements over approximately 36–38 weeks, including the number of side effects that occurred and how participants' hand eczema severity changed over time using two standard rating tools. The reported data shows that the primary thing being counted — treatment-emergent adverse events (that is, any unwanted medical occurrences that began after the study started) — totalled 1,238 events across all 801 participants over the study period. For the secondary measurements, researchers used two scoring tools. The first, called IGA-CHE, rates hand eczema severity on a scale from 0 (clear skin) to 4 (severe); the reported data shows the numbers of participants falling into each category shifted across scheduled check-in visits throughout the study, though the data as submitted does not label each time point individually. The second tool, called HECSI, scores hand eczema on a scale from 0 to 360 (higher meaning more severe); the reported average scores across visits ranged from 30.8 at the earliest recorded point down to 15.4 at the latest. The reported data also shows that the numbers of participants achieving at least a 75% improvement in their HECSI score ranged from 347 to 452 across the various visits, and those achieving at least a 90% improvement ranged from 195 to 291 across 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 ↗
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NCT04195698 · results posted 9 January 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04195698) enrolled 475 adults in total — 239 in a group that switched from a medicine called dupilumab (300 mg) to upadacitinib (30 mg), and 236 in a group that continued on upadacitinib (30 mg) throughout. The trial was primarily measuring unwanted medical events (called adverse events) that occurred during treatment, as well as changes in laboratory blood test results and physical measurements such as blood pressure, pulse, and weight. The reported data shows that, when it came to general treatment-related adverse events, 205 out of 239 participants in the dupilumab-to-upadacitinib group and 223 out of 236 in the upadacitinib-only group experienced at least one such event. For a smaller category of specially monitored adverse events (those considered of particular interest to researchers), the numbers were lower — 7 participants in the first group and 8 in the second group reported these. Regarding laboratory blood test results that were flagged as potentially clinically important (meaning notably outside the normal range and worse than at the start), the reported data shows figures ranging from 0% to 1.3% across both groups depending on the specific measurement being looked at. For physical checks like blood pressure and pulse, the reported percentages of participants with notable readings ranged from 0% to 9.3%, with the upadacitinib-only group generally showing slightly higher percentages across several of these 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.
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NCT04872101 · results posted 17 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04872101) enrolled 473 adults with chronic hand eczema — 314 were assigned to use a cream containing delgocitinib (20 mg/g) and 159 were assigned to use a plain cream vehicle (a cream with no active ingredient), which acted as the comparison group. The trial ran for 16 weeks and was primarily measuring how many participants reached a specific level of skin clearance on a five-point severity scale called the IGA-CHE, where a score of 0 means "clear" and 4 means "severe." Reaching the target — called "treatment success" — meant scoring 0 (clear) or 1 (almost clear) and improving by at least two steps from where the person started. By the end of the trial, 291 people in the delgocitinib group and 122 in the vehicle group had completed the study. The reported data shows that at the main 16-week check-point, 91 out of 314 participants in the delgocitinib group met the treatment success definition, compared with 11 out of 159 in the vehicle cream group. Earlier check-points showed similar patterns: at week 8, the numbers were 101 versus 15, and at week 4, they were 46 versus 13. The trial also tracked itch and other hand eczema symptoms using a daily diary scored from 0 to 10. At week 16, among participants whose itch score was at least 4 at the start, 146 in the delgocitinib group and 31 in the vehicle group reported a reduction in itch of 4 or more points. When looking at an overall symptom score (covering six signs and symptoms combined), 137 participants in the delgocitinib group and 32 in the vehicle group reached that same 4-point reduction at week 16. At week 8, the itch reduction numbers were 131 versus 21. 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 ↗
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NCT04773587 · results posted 9 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04773587) enrolled 654 people with atopic dermatitis (eczema) — 433 in the roflumilast cream 0.15% group and 221 in the vehicle cream (a cream without the active ingredient, used as a comparison) group. The trial ran for 4 weeks and was mainly measuring how many participants reached a rating of "clear" or "almost clear" skin on a standard severity scale called the vIGA-AD, which runs from 0 (clear) to 4 (severe). To count as a success on this scale, a participant also needed to improve by at least 2 grades from where they started. The reported data shows that at Week 4, 32.0% of participants using roflumilast cream met the "clear or almost clear" success standard, compared with 15.2% of those using the vehicle cream. Among secondary measures, the reported data shows that in participants who started with "moderate" severity scores, 35.0% in the roflumilast group and 17.5% in the vehicle group reached that same success level by Week 4. For itching — measured in participants aged 12 and over using a self-reported scale from 0 ("no itch") to 10 ("worst imaginable itch") — the reported data shows that 33.6% of the roflumilast group and 20.7% of the vehicle group achieved a reduction of 4 or more points by Week 4. Earlier timepoints showed smaller proportions reaching that itch reduction: at Week 2, the figures were 23.8% versus 9.8%, and at Week 1, 9.5% versus 2.3%. A separate skin-area-and-severity score (EASI) showed that 43.2% of the roflumilast group and 22.0% of the vehicle group had their overall eczema score reduce by 75% or more by Week 4. 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 ↗
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NCT05375929 · results posted 19 September 2024
According to the results reported on ClinicalTrials.gov, this trial studied a medicine called abrocitinib in people with atopic dermatitis (eczema). The main part of the trial enrolled 200 participants, split roughly evenly between a higher dose (200 mg once daily, n=99) and a lower dose (100 mg once daily, n=101), and ran for 12 weeks followed by a 4-week check-in. A smaller sub-study enrolled an additional 35 participants (19 on the higher dose, 16 on the lower dose) who took the medicine for up to one year. The trial was measuring things like unwanted medical events that occurred during the study, as well as changes in the appearance and symptoms of participants' eczema over time. The reported data shows that in the main study, 30 out of 99 participants in the higher-dose group and 26 out of 101 in the lower-dose group experienced at least one adverse event (an unwanted medical occurrence during the study period). Serious adverse events — meaning events serious enough to require hospitalisation or were otherwise considered significant — were reported for 0 participants in the higher-dose group and 1 participant in the lower-dose group. On a standard eczema severity skin assessment scored by a clinician (called IGA), around 48–50% of participants in both groups reached a score of "clear" or "almost clear" by week 12. On a broader skin-coverage scoring tool (EASI), roughly 72% of the higher-dose group and 69% of the lower-dose group showed at least a 75% improvement in their score from the start of the study. On another combined scoring tool (SCORAD), approximately 48% and 43% respectively reached that same 75% improvement mark. Participant-reported scores for eczema symptoms (POEM, scored 0–28 where higher means worse) showed average reductions from baseline of about 14 points (higher dose) and 12 points (lower dose) by week 12. A separate participant-reported eczema control tool (ADCT, scored 0–24 where higher means less control) showed average reductions of about 13 points (higher dose) and 12 points (lower dose) 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.
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NCT03985943 · results posted 14 August 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03985943) looked at a medicine called nemolizumab for people with atopic dermatitis (eczema). The trial ran in two stages: an initial 16-week period where 321 people received a placebo (a dummy treatment with no active ingredient) and 620 people received nemolizumab 30 mg, followed by a longer maintenance period running to week 48, where participants were reassigned into four different groups totalling 372 people. The trial was measuring two main things at the 16-week mark: how much the overall skin condition improved (using a doctor's rating scale and a skin severity scoring system), and how much itching improved (using a participant-reported itch scale). The reported data shows the following results at week 16. For the doctor's overall skin rating (called IGA — a five-point scale where 0 means clear and 4 means severe), the proportion of participants whose skin was rated as clear or almost clear with at least a two-grade improvement was 24.6% in the placebo group compared with 35.6% in the nemolizumab group (across all participants), and 21.4% versus 35.5% in the subgroup who started with severe itching. For the skin severity scoring system (EASI), the proportion of participants whose scores improved by 75% or more was 29.0% in the placebo group versus 43.5% in the nemolizumab group (all participants), and 23.8% versus 41.6% in the severe itching subgroup. For the itch scale (rated 0–10 by participants), the proportion who reported an improvement of four or more points was 17.8% in the placebo group versus 42.7% in the nemolizumab group (all participants), and 18.6% versus 46.1% in the severe itching subgroup. 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 ↗
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NCT05194540 · results posted 20 June 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 136 adults who received the medication tralokinumab delivered by an autoinjector (a self-injection pen) for the treatment of eczema (also called atopic dermatitis). Of those who started, 117 completed the trial and 19 did not finish. The trial was measuring how well participants' eczema responded after 16 weeks, using two standard scoring tools: one where a doctor rates overall skin clearance on a scale of 0 (clear) to 4 (severe), and another that measures the area and severity of eczema across the body on a scale of 0 to 72. The reported data shows that at the 16-week mark, 28.7% of participants had a doctor-rated score of 0 (clear) or 1 (almost clear) on the overall skin assessment. Separately, 43.4% of participants showed at least a 75% reduction in their eczema area and severity score compared to the start of the trial. These two figures were the trial's main measurements. The reported data also shows that 86 unwanted health events (known as adverse events) were recorded across all participants between the first injection and week 16. Additionally, none of the 136 participants were found to have developed antibodies against the drug itself — meaning the body did not appear to mount an immune response against it in any participant, according to the data submitted. No other secondary outcome figures were 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 ↗
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NCT02004041 · results posted 11 June 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT02004041) enrolled 69 people in total — 34 in the VLY-686 (treatment) group and 35 in the placebo (inactive treatment) group. The trial was measuring changes in itch intensity over approximately 28 days. Participants rated their itch on a 100-millimetre scale, where 0 meant "no itch" and 100 meant "the worst imaginable itch." The trial tracked how much those scores changed from the start of the study to the end. The reported data shows that, on average, people in the VLY-686 group saw their itch score decrease by 40.5 mm on that scale, while people in the placebo group saw their itch score decrease by 36.5 mm. In both groups, scores went down from where they started — meaning both groups reported lower itch ratings by the end of the study compared to the beginning. It is worth noting that 4 people in each group did not complete the trial, and their results were captured at the point they left (early termination). No other outcome measures were included in the data 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.
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NCT04668066 · results posted 3 June 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04668066) was conducted in two parts and enrolled a total of around 110 participants across many different groups. Part 1 tested a range of single doses and multiple doses of the study drug — given either as a drip into a vein (intravenous) or as an injection under the skin (subcutaneous) — at varying amounts, alongside placebo (dummy treatment) groups. A separate Japanese cohort was also included. Part 2 enrolled 16 participants who received the study drug and 9 who received a placebo, all by intravenous drip. The trial was primarily measuring how many participants experienced adverse events (untoward medical occurrences — anything from a minor symptom to a serious medical problem) that arose after starting treatment, as well as looking at changes in vital signs, laboratory tests, heart recordings (ECGs), and how the body processed the drug over time. The reported data shows that in Part 1's single-dose groups, the number of participants who experienced a treatment-emergent adverse event ranged from 0 (in the lowest dose groups) up to 6 in the placebo group, with small numbers — typically 0 to 2 — in most active-dose groups. Serious adverse events were reported for 0 participants in most groups, with isolated instances in a small number of groups. In Part 1's multiple-dose groups, between 1 and 5 participants per group experienced a treatment-emergent adverse event, with serious adverse events reported for 0 or 1 participant in most groups. In Part 2, the reported data shows 4 out of 16 participants in the active-drug group and 5 out of 9 in the placebo group experienced a treatment-emergent adverse event; serious adverse events were reported for 0 participants in the active group and 1 in the placebo group. The reported data for other primary outcome measures — such as vital signs, laboratory findings, ECG readings, and how the drug moved through the body — was not fully available 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.
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NCT05117060 · results posted 31 May 2024
According to the results reported on ClinicalTrials.gov, this trial tested three different doses of an investigational treatment called LEO 152020, plus a placebo (a dummy treatment with no active ingredient), in people with atopic dermatitis (eczema). A total of 216 people started the trial — 61 in the higher dose group, 45 in the middle dose group, 49 in the lower dose group, and 61 in the placebo group. The main thing the trial was measuring was a change in eczema severity using a scoring system called the EASI (Eczema Area and Severity Index), which runs from 0 to 72, where higher numbers mean more severe or widespread eczema. This was measured from the start of the trial to week 16. The reported data shows that all four groups had a reduction in their EASI scores over 16 weeks — meaning their scores went down from where they started. The higher dose group's average score dropped by 9.99 points, the middle dose group by 8.83 points, the lower dose group by 8.87 points, and the placebo group by 9.11 points. These reported figures are notably similar across all groups, including the placebo group. The trial also counted the number of unwanted health events (called adverse events) that occurred during the treatment period. The reported data shows 109 such events in the higher dose group, 67 in the middle dose group, 80 in the lower dose group, and 75 in the placebo group. No further breakdown of these events was 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT04140695 · results posted 14 May 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04140695) enrolled 87 people in total — 43 received a medicine called tradipitant and 44 received a placebo (a dummy treatment with no active ingredient). The trial was measuring itch severity using a tool called the Worst Itch Numeric Rating Scale (WI-NRS), which asks people to rate their itch on a scale from 0 (no itch) to 10 (the worst itch imaginable). The main goal was to see how many participants experienced a meaningful drop in their itch score — specifically, a reduction of at least 4 points from their starting score — by week 2. Not everyone finished the trial: 33 of the 43 tradipitant participants and 32 of the 44 placebo participants completed it. The reported data shows that at the two-week mark, only a small number of participants in either group met that threshold of a 4-point or more reduction in their itch score. In the tradipitant group, 2 out of 43 participants reached this level of reduction, while in the placebo group, 4 out of 44 participants did. No additional outcome measures were included in the submitted results data, so further detail on other aspects of the trial was not reported in the 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.
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NCT05017480 · results posted 1 May 2024
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called CBP-201 in people with atopic dermatitis (eczema). In the first stage of the trial, 219 people received CBP-201 (given as an injection every two weeks) and 111 people received a placebo (a dummy treatment with no active ingredient). The trial was measuring things like how much the skin's overall appearance improved, how much the affected skin area and severity changed, and how much itching reduced. A second stage then followed, involving a further 311 participants across three groups who continued or switched treatments, though the results data provided covers the first stage comparison between CBP-201 and placebo. The reported data shows that for the main outcome — the proportion of people whose skin was rated as "clear" or "almost clear" by a doctor and whose score improved by at least 2 points on a 5-point scale — 29.0% of people in the CBP-201 group reached this point, compared with 5.9% in the placebo group. For a measure of eczema area and severity (called EASI), 58.6% of those on CBP-201 saw at least a 75% reduction in their score from the start, compared with 22.6% in the placebo group; and 33.4% of the CBP-201 group saw at least a 90% reduction, versus 6.4% in the placebo group. The reported data also shows results for itching, measured on a 0–10 scale where 10 is the worst imaginable itch. On average, people in the CBP-201 group reported their itch score dropping by about 2.95 points, compared with about 0.99 points in the placebo group. Looking at the proportion of people whose itch score dropped by 4 or more points, 36.3% in the CBP-201 group reached this, compared with 10.5% in the placebo group; for a drop of 3 or more points, it was 50.0% versus 20.3%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04378569 · results posted 5 April 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04378569) tested a cream called ARQ-252 on people with hand eczema. A total of 230 participants were enrolled across two groups, called Cohort 1 and Cohort 2. Cohort 1 was a smaller, earlier group of 7 people who received ARQ-252 cream at a 0.3% strength once daily. Cohort 2 was larger, with the remaining participants split across different versions of the cream — different strengths and how often it was applied (once or twice daily) — as well as a "vehicle cream," which is a plain cream containing no active ingredient, used for comparison purposes. The trial was measuring both how participants responded to the cream and any medical events that occurred during the study. The reported data shows that in Cohort 1, out of 7 participants, 1 person experienced at least one adverse event (an unexpected medical occurrence during the study), and no participants experienced a reaction at the application site, a serious adverse event, or notable changes in blood test results. For Cohort 2, the main thing being measured was how many participants reached a score of "clear" or "almost clear" on a 5-point scale that doctors used to rate the severity of hand eczema (where 0 means completely clear and 4 means severe). The reported data shows that at 12 weeks, 23 out of 65 participants receiving the 0.3% cream once daily, 15 out of 61 receiving the 0.3% cream twice daily, and 10 out of 32 receiving the 0.1% cream once daily reached that "clear" or "almost clear" rating. In the combined vehicle cream (plain cream, no active ingredient) group, 16 out of 65 participants reached that same 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT02589392 · results posted 26 February 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT02589392) enrolled 120 people in total — 60 in a group using both a moisturiser and a body wash, and 60 in a group using a body wash only. The trial was measuring how long it took for participants' skin condition to relapse (return or worsen) after a period of treatment. Six people in each group did not complete the study, meaning 54 in each group finished. The reported data shows that the trial tracked "time to relapse," meaning the number of days from the start of the study until a participant's condition came back. Because at least half of participants in each group had not relapsed by the end of the study, researchers instead reported the point at which 25% of participants in each group had relapsed (this is called the "25th quantile" — simply the number of days by which one quarter of the group had experienced a relapse). According to the results reported on ClinicalTrials.gov, in the moisturiser plus body wash group, 25% of participants had relapsed by day 48. In the body wash only group, 25% of participants had relapsed by day 15. 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 ↗
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NCT03667014 · results posted 9 January 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03667014) enrolled 34 adults who received the medication dupilumab for their atopic dermatitis (eczema). Twenty-four participants completed the study, while 10 did not finish. The trial was measuring changes over 16 weeks in a range of self-reported scores covering general wellbeing, skin-related quality of life, itch, pain, sleep quality, and work productivity. The reported data shows the following changes between the start of the trial (baseline) and week 16. For the main measure — the Psychological General Well-Being scale (a 0–110 total score where higher means better wellbeing) — the reported average score moved from 68.3 at the start to 73.7 at week 16. For the Dermatology Life Quality Index (0–30, where higher means more impact on daily life), the average score went from 16.4 down to 8.0. The itch rating (0–10, where 10 is the worst imaginable itch) went from 7.7 to 3.5, and the pain rating (also 0–10) went from 5.3 to 2.0. Sleep quality, measured on a 0–21 scale where higher scores indicate worse sleep, moved from 10.05 to 6.59. For work and activity impairment (expressed as a proportion from 0 to 1, where higher means more impairment), the reported figure moved from 0.45 to 0.24. It is worth noting that the reported data does not include information on how much of these changes might be due to the treatment itself versus other factors, as there was no comparison group 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 ↗
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NCT05014438 · results posted 18 October 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT05014438) looked at atopic dermatitis (eczema) and involved a total of 17 people across five groups — one placebo group and four treatment groups, with 3 to 4 people in each group. Of those, 13 completed the study. The trial measured several things related to eczema severity over 16 weeks, including a skin scoring system called the EASI (which rates eczema across the body on a scale of 0 to 72, where lower is better), a doctor's overall rating of skin clearance, itch intensity, and how much of the body's skin surface was affected. The reported data shows the following for the primary outcome — the percentage change in EASI score from the start of the trial to week 16: the placebo group showed an average reduction of 83.1%, and Treatment 4 showed an average reduction of 92.3%. Figures for Treatment 1, 2, and 3 were not reported for this measure. For the secondary outcomes, no participants in any group — placebo or treatment — reached the threshold of having their skin rated as "cleared" or "almost cleared" by the doctor at week 16. When looking at whether participants' itch scores dropped by 4 or more points, the reported data shows 25% of the placebo group, 50% of Treatment 3, and 50% of Treatment 4 met that threshold, while 0% in Treatments 1 and 2 did. Some figures for certain groups across several measures were not reported in the submitted data. It is worth noting that this was a very small study — fewer than 20 people in total — and the reported data shows incomplete figures across several outcome measures for some 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.
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NCT01949311 · results posted 17 October 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT01949311) enrolled 2,677 people, all of whom received the medicine dupilumab. The trial was a single-group study — meaning there was no separate comparison or placebo group — and it was primarily focused on tracking adverse events (that is, any unwanted medical occurrences that happened during the study period). Of the 2,677 people who started, 1,297 completed the study, while 1,380 did not complete it; the reasons for not completing were not detailed in the data provided here. The reported data shows that across all participants, 14,717 treatment-emergent adverse events (meaning unwanted medical occurrences that happened after starting the treatment) were recorded in total. The trial also specifically tracked certain pre-defined "adverse events of special interest" — a set of particular medical events including serious allergic reactions, certain eye conditions, and some types of infections. According to the results reported on ClinicalTrials.gov, 161 of these special-interest events were recorded across the group, at a rate of approximately 2.76 such events per person per year. Nine of these special-interest events were classified as serious. An optional sub-study looking at these same special-interest events after participants switched to a new version of the dupilumab product reported zero such events, though the size of that sub-group was not detailed in the submitted data. The reported data also includes a skin severity score called the IGA (Investigator's Global Assessment), which rates skin condition on a scale from 0 (clear) to 4 (severe). At the start of the study, 12% of participants had a score of 0 or 1 (clear or almost clear skin). Across later check-in points, that percentage was reported to rise, reaching as high as 81.2% at one recorded visit, though the timing of each individual measurement 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04212169 · results posted 28 September 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04212169) enrolled 148 adults with moderate-to-severe eczema (atopic dermatitis). Participants were divided into four groups: 56 received a placebo (inactive treatment), 19 received a low dose of the investigational medicine MEDI3506, 18 received a middle dose, and 55 received a high dose. The trial's main goal was to measure how much participants' eczema severity scores changed over 16 weeks, using a standardised skin assessment tool called the EASI — a scoring system where higher numbers mean more severe disease, with a maximum of 72. The reported data shows that for the primary outcome — percentage change in the EASI score from the start of the trial to week 16 — the results were recorded as "not available" (NA) for the overall statistical model used. However, the individual group figures reported show an average reduction in EASI scores of around 51% for the placebo group, 50% for the low-dose group, 45% for the middle-dose group, and 53% for the high-dose group. For the secondary outcomes at week 16: when looking at participants whose EASI score dropped by at least 75%, 4 people in the placebo group reached this threshold compared to 2, 1, and 10 in the low-, middle-, and high-dose groups respectively. Regarding itch — measured on a 0–10 scale where higher means worse — 9 placebo participants, 3 in each of the two lower-dose groups, and 12 in the high-dose group reported their itch score dropping by 3 or more points. Regarding the doctors' overall skin-clearance rating (IGA score of clear or almost clear), 1 person in the placebo group, 1 in the low-dose group, none in the middle-dose group, and 5 in the high-dose group reached that level. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05439941 · results posted 7 September 2023
According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called EDP1815 for people with atopic dermatitis (a type of eczema). It included three groups of participants — 104 people in Group 1, 102 in Group 2, and 79 in Group 3 — giving a total of 285 participants across the study. The trial was designed to track participants over a 36-week treatment period plus a 4-week follow-up. The main thing being measured was how often unwanted health events (called adverse events) occurred during the study. Several secondary measures looked at changes in eczema severity using a scoring system called the EASI scale, which rates how much of the body is affected and how severe the skin symptoms are. The reported data shows that no numerical results have been submitted to ClinicalTrials.gov for any of the outcome measures — neither for the primary measure (the rate of adverse events) nor for any of the secondary measures (such as the percentage of participants whose EASI scores improved by 50%, 75%, or 90%, or the average change in EASI scores). The data was not reported for these outcomes. It is also noted that the records show zero participants listed as having "completed" the study across all three groups, though the reasons for this are 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.
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NCT05121480 · results posted 16 August 2023
According to the results reported on ClinicalTrials.gov, this trial tested a treatment called EDP1815 for eczema across four groups of participants (called Cohorts 1–4). Each cohort included people who received either the active treatment or a placebo (a dummy treatment with no active ingredient). In total, 421 people started the trial — 421 across all groups combined — and the main thing being measured was a skin-scoring tool called the EASI (Eczema Area and Severity Index), which runs from 0 to 72, where a lower score means less severe eczema. The key goal was to see how many participants had their EASI score drop by at least 50% (known as "EASI-50") by week 16. The reported data shows that at week 16, the number of participants reaching the EASI-50 milestone (a 50% or greater reduction in their eczema score) was: 27 out of those in Cohort 1 active, 25 in Cohort 2 active, and 23 in Cohort 3 active, compared with 38 in the combined placebo group for Cohorts 1–3. In the separately reported Cohort 4, 25 active participants and 17 placebo participants reached EASI-50. The reported data also shows that when looking at a 75% reduction in score (EASI-75) at week 16, numbers ranged from 9 to 11 participants across the active groups, compared with 5 in the Cohorts 1–3 placebo group and 9 in the Cohort 4 placebo group. For average percentage change in the EASI score at week 16, the reported figures ranged from roughly −22% to −36% across the active groups, and approximately −31% to −43% in the placebo groups — noting that the placebo groups also showed score reductions over the course of 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.
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NCT04444752 · results posted 1 August 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04444752) enrolled 226 adults with moderate-to-severe eczema (atopic dermatitis). Participants were divided into four groups: three groups received different doses or dosing schedules of an investigational medicine called CBP-201 (either 150 mg every two weeks, 300 mg every two weeks, or 300 mg every four weeks), while a fourth group received a placebo (an inactive treatment). The trial's main goal was to measure how much eczema severity — scored using a validated tool called the EASI score, which runs from 0 (no eczema) to 72 (very severe) — changed from the start of the trial to week 16. The reported data shows that, on average, participants in the three CBP-201 groups had their EASI scores reduced by approximately 58%, 63%, and 64% respectively from their starting scores by week 16, compared with an average reduction of around 40% in the placebo group. For a secondary measure, the trial also tracked how many participants reached a score of 0 or 1 on a separate physician rating scale (vIGA), meaning their skin was rated as "clear" or "almost clear" by week 16. The reported data shows that 9 out of 57 participants in the 150 mg two-weekly group, 16 out of 57 in the 300 mg two-weekly group, and 11 out of 56 in the 300 mg four-weekly group reached this level, compared with 5 out of 56 participants 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.
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NCT04922021 · results posted 24 July 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04922021) looked at a medicine called LEO 138559 compared to a placebo (an inactive dummy treatment) in people with atopic dermatitis, commonly known as eczema. A total of 58 people took part — 29 in the LEO 138559 group and 29 in the placebo group. The main thing the trial was measuring was how much participants' eczema changed over 16 weeks, using a scoring system called the EASI (Eczema Area and Severity Index). This is a scale from 0 to 72, where higher numbers mean more severe or widespread eczema. The reported data shows that, on average, people in the LEO 138559 group had their EASI score go down by 15.3 points from where they started, while people in the placebo group had their score go down by 3.5 points. The trial also recorded the number of unwanted medical events (called adverse events) that appeared during the study period. The reported data shows that the LEO 138559 group had a total of 40 such events across participants, compared to 26 in the placebo group. It is worth noting that not everyone finished the study — 22 out of 29 in the LEO 138559 group completed it, compared to 16 out of 29 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.
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NCT03952559 · results posted 29 June 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03952559) involved children and adolescents with atopic dermatitis (eczema). A total of 33 participants took part in an initial open-label phase where everyone received a high dose of baricitinib, mainly to study how the drug moved through the body at different ages. Then, 483 participants entered a double-blind phase — meaning neither the participants nor the doctors knew who was receiving which treatment — and were split into four groups: placebo (no active medicine), baricitinib low dose, baricitinib medium dose, or baricitinib high dose. The trial measured several things, including how many participants' skin cleared or nearly cleared according to a doctor's rating scale, and how much their eczema scores changed over time. The reported data shows that for the main skin-clearance measure — the proportion of participants whose doctor rated their skin as clear or almost clear, with at least a 2-point improvement on a 5-point scale — the figures were: 16.4% in the placebo group, 18.2% in the low-dose group, 25.8% in the medium-dose group, and 41.7% in the high-dose group. For a secondary measure looking at at least a 75% improvement in a detailed eczema scoring system (scored 0–72), the reported figures were 32.0% (placebo), 32.2% (low dose), 40.0% (medium dose), and 52.5% (high dose). For an even larger improvement of 90% or more on that same scale, the figures were 12.3%, 11.6%, 21.7%, and 30.0% respectively. The reported data also shows average reductions in the eczema score from the start of the trial: −14.16 points (placebo), −15.67 (low dose), −15.83 (medium dose), and −16.88 (high dose). For the open-label phase, the trial also measured how much of the drug was present in participants' blood at steady levels across three age groups (2 to under 6, 6 to under 10, and 10 to under 18 years). The reported peak blood concentration figures were 63.2, 40.1, and 50.6 nanograms per millilitre respectively, and the reported total drug exposure figures over a dosing period were 251, 178, and 290 hour-nanograms per millilitre — these are technical measurements used to understand how the body processes the medicine at different ages. 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 ↗
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NCT04605094 · results posted 27 June 2023
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called benralizumab as a potential treatment for atopic dermatitis (eczema). A total of 96 people were assigned to receive benralizumab and 98 people received a placebo (a dummy treatment with no active ingredient). Of those who started, 37 people in each group completed the study, meaning a large number — 59 in the benralizumab group and 61 in the placebo group — did not finish for various reasons. The reported data shows the main thing the trial was measuring was how many participants had their eczema rated as "clear" or "almost clear" by a doctor at 16 weeks, with at least a 2-point improvement on a 5-point severity scale. According to the results reported on ClinicalTrials.gov, 9.4% of people in the benralizumab group met this target, compared with 17.3% in the placebo group. For the secondary measures — which were additional things the trial tracked — the reported data shows that 19.8% of the benralizumab group versus 24.5% of the placebo group had at least a 75% reduction in an eczema severity and body-coverage score; 7.3% versus 15.3% had at least a 90% reduction in that same score; and 14.6% versus 14.3% reported a meaningful drop (4 or more points on a 0–10 scale) in their worst itch score in the week around the 16-week mark. In all of the reported measures, the numbers in the benralizumab group were similar to or lower than those in the placebo group at 16 weeks, though the reasons for this are not explained in the structured data 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 ↗
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NCT04162899 · results posted 9 May 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04162899) enrolled 105 people in total — 35 in each of three groups. Two groups received different doses of a medicine called SHR0302 (referred to as Dose A and Dose B), and one group received a placebo (a dummy treatment with no active ingredient). The trial was measuring outcomes related to atopic dermatitis (a type of eczema), including how much skin clearing participants achieved, changes in the area and severity of their eczema, and changes in itch levels. Not everyone finished the trial: 29 of 35 completed it in the Dose A group, 32 of 35 in the Dose B group, and 23 of 35 in the placebo group. The reported data shows that the main thing being measured — called the IGA response — tracked how many participants reached a score showing their skin was completely or almost completely clear, while also improving by at least 2 points on the rating scale from where they started. According to the results reported on ClinicalTrials.gov, 9 out of 35 participants in the Dose A group, 19 out of 35 in the Dose B group, and 2 out of 35 in the placebo group met this measurement point. For the secondary outcomes — including changes in eczema area and severity, a separate skin clearance measure, and changes in itch scores — the data was 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03058783 · results posted 8 May 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03058783) enrolled 326 people with atopic dermatitis (a skin condition also known as eczema) — 216 were assigned to use IDP-124 Lotion and 110 were assigned to use a vehicle lotion (a lotion without the active ingredient, used for comparison). Of those, 180 and 80 participants respectively completed the trial. The study was measuring things like how much the overall skin appearance improved, how much the area and severity of eczema changed, and how much itching (pruritus) improved, all assessed at several points up to six weeks. The reported data shows that for the main (primary) outcome at week 6 — the proportion of participants whose skin was rated "clear" or "almost clear" and had improved by at least two steps on a five-point scale — 42% of the IDP-124 Lotion group reached this point, compared with about 33% in the vehicle lotion group. For the secondary outcomes, the reported data shows that the proportion of participants who achieved at least a 75% reduction in an eczema area and severity score (called EASI 75) ranged from roughly 34% to 46% in the IDP-124 Lotion group and from about 26% to 37% in the vehicle lotion group across different time points. For itching, between about 46% and 53% of participants using IDP-124 Lotion were reported to have improved to "none" or "mild" itch, compared with roughly 37% to 40% in the vehicle lotion 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.
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NCT03250624 · results posted 1 May 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03250624) enrolled 63 adults with atopic dermatitis (eczema) — 32 were assigned to use CD5024 0.3% Cream and 31 to use a placebo (an identical-looking cream with no active ingredient). The trial was measuring changes in eczema severity over approximately six weeks, using several standardised scoring tools that rate things like redness, skin thickening, scratching damage, and itch. The reported data shows that for the primary outcome — change in a standard eczema severity score called the EASI (which runs from 0, meaning no disease, to 72, meaning very severe) — the CD5024 cream group's average score fell by 2.64 points from their starting level by day 43, while the placebo group's average score fell by 2.36 points. When tracked across all visits, the percentage reduction in that same EASI score grew over time: by the final visit, the CD5024 group showed an average reduction of about 46%, compared with about 25% in the placebo group. For the "almost clear or clear skin" measure, 37.5% of participants in the CD5024 group reached that rating by the last visit, compared with 9.68% in the placebo group. Other scoring tools — measuring overall symptom burden and itch intensity on a 0–10 scale — also showed reductions in both groups across the study period, with the reported numbers for the CD5024 group generally somewhat larger than those for the placebo group at most 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.
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NCT03921411 · results posted 21 April 2023
According to the results reported on ClinicalTrials.gov, 20 people were enrolled in this trial, all of whom received the study drug nemolizumab (18 were actually treated and 15 completed the study, with 5 not completing it). The trial was measuring how much nemolizumab was present in participants' blood (called serum concentrations) at several points in time over 24 weeks. This type of measurement — sometimes called a pharmacokinetic study — is about tracking how a drug moves through the body over time, rather than measuring whether symptoms improved. The reported data shows the average amount of nemolizumab measured in the blood at each time point, expressed in nanograms per millilitre (ng/mL), which is simply a way of describing how much of the drug was detected in a small volume of blood. At weeks 1–2, the reported concentration was 6,478.8 ng/mL. This then dropped to 2,935.3 ng/mL at week 4. The levels remained in a similar range through weeks 8 (3,292.3 ng/mL), 12 (3,221.6 ng/mL), and 16 (3,010.0 ng/mL), before falling considerably to 473.9 ng/mL at week 24. No other 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 ↗
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NCT04040192 · results posted 8 March 2023
According to the results reported on ClinicalTrials.gov, this trial involved 497 people aged 6 years and older who had eczema (atopic dermatitis). In the first part of the trial — an open-label phase lasting up to 8 weeks — all 497 participants used crisaborole 2% cream twice daily. Of those, 270 went on to the second part: a double-blind phase (where neither the participant nor the researcher knew which treatment was being used) lasting up to 52 weeks. In this second phase, 135 participants were randomly assigned to use crisaborole 2% cream once daily, and 135 were assigned to use a vehicle cream (a cream without the active ingredient) once daily. The trial was primarily measuring how long participants went without an eczema flare-up, and also tracking any unwanted medical events (called adverse events) that occurred during the study. The reported data shows that, during the double-blind phase, participants in the crisaborole once-daily group went a median of 111 days before their first flare-up, compared with 30 days in the vehicle group. (A "median" figure means half the participants in each group reached that point sooner, and half took longer.) For the secondary measures, the reported data shows the crisaborole once-daily group averaged around 234 flare-free days over the study period, compared with approximately 199 days in the vehicle group. The average number of flare-ups recorded was 1 in both groups. Regarding unwanted medical events, 109 out of 497 participants in the open-label (twice-daily) phase reported such events, while in the double-blind phase, 36 out of 135 in the crisaborole once-daily group and 49 out of 135 in the vehicle group reported them. Some of the itch-related secondary results were listed as "not available" for the vehicle group, meaning those figures 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 ↗
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NCT04250350 · results posted 24 February 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 206 adults who received lebrikizumab 250 mg for atopic dermatitis (eczema). Of those, 172 completed the study and 34 did not. The trial was measuring how many participants stopped taking the treatment because of unwanted side effects (the primary measure), as well as how much participants' eczema changed over time using two standardised doctor-assessed scoring tools — the Investigator Global Assessment (IGA), which rates overall skin severity on a scale of 0 (clear) to 4 (severe), and the Eczema Area and Severity Index (EASI), which scores both how much of the body is affected and how severe the signs are, on a scale of 0 to 72. The reported data shows that 2.4% of participants stopped taking the study treatment due to one or more adverse events (unwanted side effects). For the secondary measures, the reported data shows that 62.6% of participants reached an IGA score of 0 or 1 (clear or almost clear skin) with at least a 2-point drop from their starting score. Using the EASI tool, 94.4% of participants were reported to have achieved at least a 50% reduction from their starting score, 81.9% achieved at least a 75% reduction, and 61.4% achieved at least a 90% reduction. The reported data also shows an average reduction of 86.0% in EASI scores across participants from the start of the study. It is important to note that this trial had no comparison group (such as a placebo or dummy treatment group), so the reported numbers reflect only what was observed in people receiving lebrikizumab, without a direct 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 ↗
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NCT04162769 · results posted 4 November 2022
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called etrasimod as a treatment for atopic dermatitis (eczema). In the first part of the trial, 140 people took part across three groups: 47 received a 1 mg daily dose of etrasimod, 47 received a 2 mg daily dose, and 46 received a placebo (a dummy pill with no active ingredient). This phase ran for 12 weeks. Afterwards, 95 participants moved into a longer open-label extension phase lasting 52 weeks, where everyone received the 2 mg dose of etrasimod. The trial measured changes in eczema severity using several scoring tools, including a detailed skin assessment called the EASI score (which runs from 0 to 72, with higher numbers meaning more severe eczema), a doctor's overall rating of skin appearance, and a self-reported itch scale. The reported data shows that after 12 weeks, the average EASI score fell by about 58.7% in the 1 mg group, 57.2% in the 2 mg group, and 48.4% in the placebo group, compared to where each group started. For secondary measures, the reported data shows that around 27.7% of the 1 mg group and 38.3% of the 2 mg group achieved at least a 75% reduction in their EASI score, compared with 26.1% in the placebo group. When looking at the doctor's overall skin rating, about 14.9% of the 1 mg group and 29.8% of the 2 mg group reached a score of "clear" or "almost clear" skin with at least a 2-point improvement, versus 13.0% in the placebo group. For itch, the reported average reduction in the itch score was about 38.4% in the 1 mg group, 35.0% in the 2 mg group, and 24.4% in the placebo group. Around 45% of participants in both etrasimod groups, and 41% in the placebo group, reported a drop of 3 or more points on the itch scale. Roughly 61.7% (1 mg group) and 66.0% (2 mg group) achieved at least a 50% reduction in EASI score, compared with 52.2% 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 ↗
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NCT03824405 · results posted 27 September 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03824405) enrolled 200 people in total — 100 in each group. Participants were randomly assigned to receive either BTX 1204 or a vehicle (a comparison product containing no active ingredient, sometimes called a placebo). The trial was measuring a skin assessment called the Investigator's Global Assessment (IGA), where a treating investigator rated how a participant's skin looked on a scale, and "success" was defined as the skin being rated "Clear" or "Almost Clear" — with the rating improving by at least two steps from the starting point. Of the 200 who started, 65 in the BTX 1204 group and 55 in the vehicle group completed the study; 35 and 45 respectively did not complete it. The reported data shows that, for the primary outcome (IGA success), 12 out of 100 participants in the BTX 1204 group met the definition of success, compared with 18 out of 100 participants in the vehicle group. The data as submitted also includes two further numbers — 87 for the BTX 1204 group and 77 for the vehicle group — however, the structured data does not clearly label what these figures represent, so it would not be accurate to describe them further 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.
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NCT04178967 · results posted 16 September 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04178967) enrolled 445 participants across its induction and maintenance phases, testing a medicine called lebrikizumab against a placebo (an inactive injection) in people with atopic dermatitis — a condition commonly known as eczema. The trial was structured in stages: an initial "induction" period where 150 people received placebo and 295 received lebrikizumab every two weeks, followed by maintenance and open-label phases involving smaller groups who were reassigned based on how they responded. The trial was measuring changes in skin condition using two main scoring tools — one called the IGA (a doctor's rating of overall skin severity on a scale of 0 to 4) and one called the EASI (a more detailed score combining the area of skin affected and how severe the signs were). The reported data shows that by week 16, 33.2% of participants in the lebrikizumab group reached a score of 0 or 1 on the IGA (meaning near-clear or clear skin, with at least a 2-point improvement from their starting score), compared with 10.8% in the placebo group. On the EASI measure, 52.1% of the lebrikizumab group achieved at least a 75% reduction in their score from the start (known as EASI-75), compared with 18.1% in the placebo group. A stricter version of this measure — a 90% or greater reduction in EASI score — was reported in 30.7% of the lebrikizumab group versus 9.5% in the placebo group. Earlier in the trial, at week 4, 9.0% of the lebrikizumab group and 1.4% of the placebo group had reached the IGA target; at week 2, the figures were 0.7% and 0% 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 ↗
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NCT04146363 · results posted 29 August 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04146363) looked at a medicine called lebrikizumab in people with atopic dermatitis (eczema). In the first phase of the trial, 141 people received a placebo (a dummy injection with no active medicine) and 283 received lebrikizumab every two weeks. After this initial 16-week phase, participants were sorted into further groups depending on how they had responded — some continued into a blinded maintenance phase (where neither the participant nor the doctor knew which treatment they were receiving), and others who had not responded well enough moved into an open-label phase where everyone received lebrikizumab. In total, across all phases, several hundred participants were involved in the study. The reported data shows the following for the two main outcomes measured at 16 weeks: For the first primary outcome — the proportion of people whose skin was rated as clear or nearly clear by a doctor (a score of 0 or 1 on a 5-point scale), with at least a 2-point improvement — 12.7% of the placebo group and 43.1% of the lebrikizumab group met this threshold. For the second primary outcome — the proportion of people who achieved at least a 75% reduction in a detailed skin severity score called the EASI — 16.2% of the placebo group and 58.8% of the lebrikizumab group reached this level. The reported data also shows that at an even higher bar (a 90% reduction in the EASI score), 9.0% of the placebo group and 38.3% of the lebrikizumab group met that threshold at week 16. At earlier time points, the reported numbers were lower across both groups — for example, at week 2, 0.7% of the placebo group and 2.5% of the lebrikizumab group met the clear or nearly clear skin measure, rising to 0.8% and 10.6% respectively by week 4. When looking only at adult participants at week 16, the reported figures were 11.3% for placebo and 42.2% for lebrikizumab on that same clear or nearly clear skin 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 ↗
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NCT04345367 · results posted 8 July 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04345367) enrolled 727 adults with atopic dermatitis (eczema) — 362 in the abrocitinib group (a once-daily tablet) and 365 in the dupilumab group (an injection given every two weeks). The study was measuring two main things at early timepoints: how quickly each treatment reduced itch (scored on a 0–10 scale, where higher means worse), and how many participants saw a 90% or greater improvement in the overall area and severity of their eczema by week 4. The reported data shows that for the primary outcomes, 48.2% of participants in the abrocitinib group and 25.5% in the dupilumab group reported at least a 4-point drop in their worst itch score by week 2. For eczema area and severity, 28.5% of the abrocitinib group and 14.6% of the dupilumab group reached a 90% or greater improvement by week 4. As the study continued, the reported data shows the gap between the two groups appeared to narrow over time: by week 26, 54.6% of the abrocitinib group and 47.6% of the dupilumab group had reached that 90% improvement mark. Similarly, the percentage of participants whose skin was rated "clear" or "almost clear" by a clinician rose over the 26-week period — reaching 60.0% for abrocitinib and 50.8% for dupilumab by week 26, according to the reported figures. The reported data also shows that for a slightly lower threshold — a 75% or greater improvement in eczema area and severity — 76.1% of the abrocitinib group and 71.1% of the dupilumab group met that level by week 26. These are summary numbers from the trial as a whole; the data submitted did not break results down by individual characteristics such as age or disease history. 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 ↗
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NCT03334435 · results posted 1 July 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03334435) involved people with atopic dermatitis (eczema) and looked at a medicine called baricitinib. In the first period of the study (up to about one year), 91 people received a placebo (a dummy treatment with no active ingredient), 45 received a 1 mg dose of baricitinib, 519 received a 2 mg dose, 743 received a 4 mg dose, and 247 received 2 mg in an open-label group where everyone knew what they were taking. In the second period (from about one year to nearly four years), participants were reassigned into various continuation or dose-switching groups, with between 32 and 264 people in each of those groups. The trial was measuring skin condition using a scoring system called the IGA (Investigator's Global Assessment), which runs from 0 (clear skin) to 4 (severe disease), and tracked what share of participants reached certain score levels over time. The reported data shows that, for the primary outcome in the monotherapy studies (where baricitinib was used on its own), the percentage of participants whose skin scored 0 or 1 (clear or almost clear) varied across time points and doses. At one measured time point, this figure was reported as 36.5% for placebo, 46.7% for the 1 mg group, 59.3% for the 2 mg group, and 48.6% for the 4 mg group. At later time points, the reported figures shifted — for example, dropping to 23.1%, 31.1%, 63.0%, and 37.1% respectively at another measurement. In the combination therapy study (where baricitinib was taken alongside other treatments), the reported figures for reaching an IGA score of 0 or 1 were 47.1% for placebo, 45.3% for the 2 mg group, and 31.7% for the 4 mg group at one time point, with those figures also changing at later time points. For the broader measure of reaching an IGA score of 0, 1, or 2 (a secondary outcome), the reported percentages were generally higher across all groups and time points, with the 2 mg monotherapy group reaching as high as 81.5% at one measured point. It is worth noting that these figures were calculated using a method where anyone who stopped taking the study treatment for any reason was automatically counted as not having responded — this is a conservative way of reporting results that can lower the overall percentages seen. The reported data also covers participants who had not responded well in earlier studies and were then switched to different doses; their results were reported separately. Some data points in the submitted results appear incomplete or were not fully reported in the available structured 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 ↗
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NCT03738423 · results posted 10 June 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03738423) enrolled 129 adults with atopic dermatitis (eczema) across five groups. Twenty-five to 27 people started in each group: one group received a placebo (an inactive dummy injection given every two weeks), and the remaining four groups received different doses and schedules of an investigational medicine called REGN3500. The trial's main goal was to measure how much participants' eczema severity scores changed after 16 weeks, using a standard scale called the EASI score — a 0-to-72 rating where higher numbers mean more severe eczema. It is worth noting that roughly half the participants in each group did not complete the study. The reported data shows the following changes in EASI scores from the start of the trial to week 16. In the primary analysis (which excluded data collected after participants needed additional "rescue" treatments), the placebo group's score fell by an average of 33.5%, while the REGN3500 groups saw falls ranging from 57.9% (lowest dose, 30 mg every 8 weeks) to 80.0% (300 mg every 4 weeks). In a second primary analysis that included all observations regardless of rescue treatment, the placebo group's score fell by 18.9%, and the REGN3500 groups fell by between 46.0% and 67.0%. The reported data also shows the proportion of participants whose scores improved by at least 50% (EASI-50): in the rescue-excluded analysis this ranged from 30% in the placebo group up to 100% in the 300 mg every-4-weeks group, though that figure is based on a small number of participants. For a 75% improvement threshold (EASI-75), figures ranged from 20% (placebo) to 71.4% (300 mg every 4 weeks) in the same analysis. 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 ↗
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NCT02743871 · results posted 19 May 2022
According to the results reported on ClinicalTrials.gov, this trial tested an investigational medicine called PF-06817024 across three separate parts. In total, 97 people took part. Part 1 tested different doses of the medicine given either directly into a vein (intravenously) or by injection under the skin (subcutaneously) in healthy volunteers, with some participants receiving a placebo (a dummy treatment with no active ingredient) for comparison. Part 2 involved people with a condition called chronic rhinosinusitis with nasal polyps (ongoing sinus inflammation with growths in the nose), and Part 3 involved people with atopic dermatitis (a type of eczema). The trial's primary focus — meaning the main things it set out to measure — was tracking undesirable medical events (called adverse events) that occurred during the study, to see how many participants experienced them and how serious they were. The reported data shows that in Part 1, the number of participants who experienced any adverse event during the study ranged across the different dose groups. For example, all 6 participants in the 10 mg intravenous group and all 6 in the 300 mg intravenous group reported at least one such event, while 1 out of 4 participants in the 100 mg multiple-dose group reported one. Among those whose adverse events were judged by the study doctor to be possibly related to the study medicine, numbers were generally low — for instance, 2 out of 6 in the 10 mg group, 3 out of 6 in the 300 mg group, and 1 out of 6 in the 1,000 mg group. Only 1 participant across all of Part 1 stopped the study permanently because of an adverse event. In Part 2 (the nasal polyp group), the reported data shows that 10 out of 11 participants receiving the medicine and 8 out of 9 receiving placebo experienced at least one adverse event, with 5 and 3 of those respectively judged as possibly related to treatment. No serious adverse events — meaning events that were life-threatening, required hospitalisation, or caused lasting harm — were reported in the medicine groups across Parts 1 or 2, though 1 serious adverse event was reported in the Part 2 placebo group. Data for Part 3 (the eczema group) was not reported for these primary outcome measures 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04086121 · results posted 18 May 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04086121) enrolled 14 participants, all of whom received spesolimab 600 mg. The trial was measuring the number of participants who experienced adverse events (unexpected or unwanted health occurrences) over 48 weeks, as well as several measures of skin disease severity related to atopic dermatitis (a form of eczema). It is noted that none of the 14 participants were recorded as having formally "completed" the study in the milestone data, though results were still reported for the group. The reported data shows that 9 out of 14 participants experienced at least one treatment-emergent adverse event (a health occurrence that began after starting the medication) by week 48. For the skin severity measures, the reported data shows an average reduction of approximately 3.74% in a skin scoring system called EASI (which rates redness, skin thickening, scratching marks, and skin hardening on a scale from 0 to 72, where higher means more severe) from the start of the trial to week 48. Around 33.3% of participants showed at least a 50% improvement in their EASI score, and 22.2% showed at least a 75% improvement. A separate skin assessment tool called SCORAD (scored 0–103, higher meaning more severe) showed an average decrease of about 10.07 points from the start to week 48. Additionally, 22.2% of participants reached a rating of "clear" or "almost clear" on a five-point doctor-assessed scale, having improved by at least two grades from their starting 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.
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NCT03817190 · results posted 6 May 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03817190) looked at a treatment called DS107 (taken as a 2,000 mg daily oral dose) compared to a placebo (a dummy treatment) in people with atopic dermatitis, commonly known as eczema. A total of 219 people took part — 110 in the placebo group and 109 in the DS107 group. The trial measured two main things at 16 weeks: firstly, how many participants reached a skin-clearance rating of "clear" or "almost clear" on a standard 5-point doctor-assessed scale (called vIGA-AD, where 0 = clear and 4 = severe); and secondly, how many achieved at least a 75% improvement in an eczema severity scoring system called EASI (which rates the extent and intensity of eczema across the body on a scale from 0 to 72). It is worth noting that a large number of participants did not complete the trial — 60 in the placebo group and 59 in the DS107 group. The reported data shows that for the first main measure at 16 weeks, 15 participants in the placebo group and 14 participants in the DS107 group reached the "clear" or "almost clear" skin rating. For the second main measure at 16 weeks, 30 participants in the placebo group and 27 participants in the DS107 group achieved at least a 75% improvement on the EASI score. For the additional measures tracked at earlier and later time points (weeks 4, 8, 12, 18, and 20), the reported data shows broadly similar numbers between the two groups across the various check-in points, with no consistent pattern clearly favouring one group over the other. Changes in the numerical scores on both the vIGA-AD and EASI scales over time were also recorded for both groups across all time points, as 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.
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NCT04360187 · results posted 2 May 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04360187) enrolled 391 participants in the double-blind treatment phase — 131 received a vehicle (inactive) cream applied twice a day, and 260 received crisaborole 2% ointment applied twice a day. The trial was measuring changes in eczema severity over 29 days, as well as tracking any adverse events (unexpected health events that occurred during the study), changes in blood test results, and changes in vital signs such as blood pressure and heart rate. The reported data shows that, for the main eczema severity measure (called the EASI score, a standard 0–72 scale where higher numbers mean worse eczema), the vehicle group saw an average reduction of about 43% from their starting score by day 29, while the crisaborole group saw an average reduction of about 60%. For a doctor's overall rating of skin condition (called ISGA, scored 0–4), the reported data shows that about 41% of participants in the crisaborole group and about 29% in the vehicle group reached a rating of "clear" or "almost clear" by day 29. When a stricter definition was used — requiring that rating plus at least a two-grade improvement from the start — the reported figures were about 28% for crisaborole and 16% for vehicle. Regarding adverse events, the reported data shows they occurred in approximately 46% of the crisaborole group and 44% of the vehicle group; serious adverse events were reported in about 0.4% of the crisaborole group and 0.8% of the vehicle group. Clinically significant changes in blood tests and vital signs were reported at low percentages across both groups, with specific figures available in the full ClinicalTrials.gov record. 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 ↗
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NCT04250337 · results posted 2 May 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04250337) enrolled 228 people with atopic dermatitis (eczema) — 75 in the placebo group and 153 in the lebrikizumab group. Both groups also used a topical corticosteroid (a standard steroid cream). The trial ran for 16 weeks and was measuring how much participants' skin condition improved, using two main scoring tools: the IGA (a doctor's 0–4 rating of overall skin severity, where 0 means clear skin) and the EASI (a 0–72 score combining how much of the body is affected and how severe the signs are). The trial also measured changes in itch severity using a simple 0–10 self-reported scale. The reported data shows that for the two primary (main) outcomes at week 16, the lebrikizumab group had higher percentages of participants reaching the target scores. Specifically, 41.2% of the lebrikizumab group achieved an IGA score of 0 or 1 (clear or almost clear skin) with at least a 2-point improvement, compared with 22.1% in the placebo group. For the EASI score, 69.5% of the lebrikizumab group achieved at least a 75% reduction in their score from the start of the trial, compared with 42.2% in the placebo group. For the secondary (additional) outcomes, the reported data shows that 41.2% of the lebrikizumab group achieved at least a 90% reduction in their EASI score versus 21.7% in the placebo group. On the itch scale, the lebrikizumab group reported an average reduction in itch score of about 50.7% from their starting point, compared with about 35.5% in the placebo group. Among participants who started with notably high itch scores, between 46.8% and 50.6% in the lebrikizumab group reached a meaningful reduction in itch (a drop of at least 4 points), compared with 26.4% to 31.9% 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 ↗
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NCT03568318 · results posted 31 March 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 968 participants in total — 785 adults and 183 adolescents — all of whom had moderate-to-severe eczema (atopic dermatitis). Participants were divided into six groups: adults and adolescents each received either a placebo (dummy treatment), a 15 mg dose of upadacitinib, or a 30 mg dose of upadacitinib, and all groups also used topical corticosteroids (steroid creams). The trial ran for 16 weeks and measured changes in eczema severity and itch using standardised scoring tools. The reported data shows the following results for the adult groups at week 16 (adolescent results were not separately broken out in the submitted outcome data). For the first primary measure — the proportion of participants whose eczema severity score improved by at least 75% — 26.4% of the placebo group reached this threshold, compared with 64.6% in the 15 mg group and 77.1% in the 30 mg group. For the second primary measure — a doctor's overall skin-clearance rating of "clear" or "almost clear" — 10.9% of the placebo group reached this level, versus 39.6% in the 15 mg group and 58.6% in the 30 mg group. On the secondary measures, the reported data shows that at week 16, a meaningful reduction in worst itch (a drop of at least 4 points on an 11-point scale) was recorded in 15.0% of the placebo group, 51.7% in the 15 mg group, and 63.9% in the 30 mg group. A 90% improvement in the eczema severity score was reported in 13.2%, 42.8%, and 63.1% of participants respectively. Similar patterns were also reported at the earlier four-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 ↗
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NCT03607422 · results posted 28 March 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03607422) looked at a medicine called upadacitinib for atopic dermatitis (eczema) in both adults and adolescents. There were two doses tested — 15 mg once daily and 30 mg once daily — compared against a placebo (a dummy treatment with no active ingredient). In the main 16-week double-blind period (where neither participants nor researchers knew who was getting which treatment), 242 adults and 60 adolescents received placebo, 243 adults and 58 adolescents received the 15 mg dose, and 247 adults and 62 adolescents received the 30 mg dose. After this period, many participants continued into a longer blinded extension phase. The trial measured changes in eczema severity using standardised scoring tools, as well as changes in itch. The reported data shows the following at the 16-week mark for the key measures. For the primary outcome of skin clearance (at least a 75% reduction in a standard eczema severity score called EASI), 13.3% of the placebo group reached this level, compared with 60.1% in the 15 mg group and 72.9% in the 30 mg group. For the second primary measure — a doctor's overall rating of the skin reaching "clear" or "almost clear" — 4.7% of the placebo group reached this, versus 38.8% and 52.0% in the 15 mg and 30 mg groups respectively. For the secondary outcome of a meaningful reduction in worst itch (rated on a 0–10 scale) at week 16, 9.1% of the placebo group reached that threshold, compared with 41.9% and 59.6% in the two upadacitinib groups. The reported data also shows that at the earlier two-week and four-week timepoints, differences between the placebo and upadacitinib groups in itch and skin scores were also recorded, with the placebo group consistently showing lower rates of improvement than either upadacitinib 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03809663 · results posted 10 March 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03809663) enrolled 251 adults across four groups in the part of the study that ran to completion (Part A). Participants were randomly assigned to receive either a placebo (a dummy injection) or one of three doses of tezepelumab — a medicine being investigated for eczema (atopic dermatitis). The trial measured two main things at 16 weeks: how many participants' skin was rated "clear" or "almost clear" by their doctor using a standard 0–5 scale (called the IGA), and how many participants' eczema severity score dropped by at least 75% from where it started (called EASI 75). A second part of the trial (Part B) was listed but reported zero participants enrolled, so no data from that part was available. The reported data shows that for the primary outcomes at 16 weeks, the numbers achieving the skin-clearance target (IGA score of 0 or 1) were small across all groups: 2 out of 63 in the placebo group, 4 out of 62 in the lowest tezepelumab dose group, 2 out of 63 in the middle dose group, and 5 out of 63 in the highest dose group. For the 75% improvement in eczema severity (EASI 75), the reported numbers were 8 out of 63 (placebo), 9 out of 62, 10 out of 63, and 7 out of 63 across the three tezepelumab groups respectively. For the secondary outcomes, the reported data shows that on a separate eczema severity scale (SCORAD, scored 0–103 where higher means worse), average scores fell by 8.0 points in the placebo group, 16.75 points in the lowest dose group, 11.87 points in the middle dose group, and 9.32 points in the highest dose group. On the itch scale (scored 0–10 where higher means worse itch), average scores fell by 0.71 points (placebo), 1.40 points, 0.94 points, and 0.38 points across the tezepelumab 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.
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NCT03569293 · results posted 3 February 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03569293) looked at a medicine called upadacitinib for people with atopic dermatitis (eczema). The trial included both adults and adolescents. In the main 16-week double-blind phase — where neither participants nor researchers knew who was getting the real medicine or a dummy pill (placebo) — 241 adults and 61 adolescents received placebo, 239 adults and 64 adolescents received upadacitinib 15 mg once daily, and 243 adults and 64 adolescents received upadacitinib 30 mg once daily. After this phase, most participants continued into a longer blinded extension period. The trial measured changes in eczema severity using two main scoring tools: one that assesses the area and severity of eczema across the body (called EASI), and another where a doctor rates overall skin condition on a scale from clear to severe (called vIGA-AD). The reported data shows that at the 16-week mark, 16.3% of participants in the placebo group achieved at least a 75% improvement in their EASI eczema score, compared with 69.6% in the 15 mg upadacitinib group and 79.7% in the 30 mg group. For the doctor's overall skin rating reaching "clear" or "almost clear," the reported figures were 8.4% for placebo, 48.1% for the 15 mg group, and 62.0% for the 30 mg group. The reported data also shows results for itch, measured on a scale of 0–10: by week 16, a meaningful reduction in itch score (a drop of 4 or more points) was reported in 11.8% of the placebo group, 52.2% of the 15 mg group, and 60.0% of the 30 mg group. Similar patterns in the reported numbers were seen at earlier time points, including at weeks 2 and 4. Additional secondary measures reported show that a 90% improvement in the EASI eczema score at week 16 was recorded in 8.1% of the placebo group, 53.1% of the 15 mg group, and 65.8% of the 30 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03738397 · results posted 2 February 2022
According to the results reported on ClinicalTrials.gov, this trial compared two treatments for atopic dermatitis (eczema) — dupilumab (given as an injection every two weeks) and upadacitinib (taken as a daily tablet). A total of 331 people were assigned to the dupilumab group and 342 to the upadacitinib group, with 308 and 312 people respectively completing the study. The trial used a scoring system called EASI (Eczema Area and Severity Index, scored 0–72, where higher means worse) to track changes in participants' eczema over 16 weeks. It also tracked self-reported itch intensity on a 0–10 scale. The reported data shows that by week 16, 62.6% of participants in the dupilumab group and 72.4% in the upadacitinib group had their EASI score reduce by at least 75% from where it started. For a 90% reduction, the figures were 40.3% and 61.6% respectively, and for a complete (100%) reduction, 7.9% and 28.4%. Turning to itch scores, the reported data shows an average reduction of about 50% from the starting score in the dupilumab group and about 68% in the upadacitinib group at week 16. Earlier in the trial at week 4, the reported itch reductions were around 32% for dupilumab and 60% for upadacitinib. At the very early two-week mark, 18.2% of the dupilumab group and 44.3% of the upadacitinib group had already reached that 75% EASI reduction 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 ↗
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NCT03745638 · results posted 17 December 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03745638) enrolled 631 participants across two phases. In the first phase (the first 8 weeks), 126 people used a vehicle cream (a plain cream with no active ingredient, used as a comparison group), 252 used ruxolitinib 0.75% cream, and 253 used ruxolitinib 1.5% cream, all applied twice daily. Participants then moved into a longer follow-up phase running from week 8 to week 52. The trial was measuring how well ruxolitinib cream — applied to the skin — compared to the plain cream across a range of eczema-related outcomes, including skin appearance, itch, and sleep. The reported data shows the following results at the end of the first 8-week phase. For the main outcome — the proportion of participants whose skin was rated as clear or almost clear with a meaningful improvement from the start — 15.1% of those using the plain cream reached that result, compared with 50.0% using the lower-strength ruxolitinib cream and 53.8% using the higher-strength version. For a separate skin severity score (measuring redness, swelling, and scratching across the body), 24.6% of the plain cream group showed a 75% or greater improvement, versus 56.0% and 62.1% in the two ruxolitinib groups respectively. Regarding itch — rated by participants themselves on a scale of 0 to 10 — a meaningful drop of 4 or more points was reported by 15.4% of the plain cream group, 40.4% of the lower-strength group, and 52.2% of the higher-strength group. Smaller proportions across all groups reported meaningful improvements in sleep disturbance and daytime tiredness related to sleep. The reported data also shows that during the 8-week phase, 34.9% of the plain cream group, 29.0% of the lower-strength ruxolitinib group, and 29.2% of the higher-strength group experienced at least one adverse event (an unwanted medical occurrence during the study); serious adverse events were reported in 1.6%, 0.4%, and 0.8% of those 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02068352 · results posted 23 November 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 121 adults across three groups: 41 people applied a lower-strength ointment (0.3% OPA-15406), 43 applied a higher-strength ointment (1% OPA-15406), and 37 applied a plain ointment with no active ingredient (called "vehicle," which acts as a comparison group). The trial was measuring how a skin condition — assessed using a standardised rating scale called the Investigator's Global Assessment (IGA), which runs from 0 (clear skin) to 5 (very severe) — responded after 4 and 8 weeks of treatment. By the end of the study, 31, 35, and 28 participants in each group respectively had completed the trial. The reported data shows that the main goal of the trial was to measure how many participants reached a score of 0 or 1 on the IGA scale (meaning clear or almost clear skin) at Week 4, with at least a 2-point improvement from their starting score. According to the results reported on ClinicalTrials.gov, approximately 14.6% of participants in the lower-strength group, 20.9% in the higher-strength group, and 2.7% in the plain ointment group met this target at Week 4. When looking at the average change in the IGA score from the start of the trial to Week 4, the lower- and higher-strength groups each showed an average reduction of around 0.55 points, while the plain ointment group showed a reduction of around 0.09 points (a lower number means improvement). A separate skin severity score called the EASI (scored out of 72, where lower is better) also showed reductions from baseline across all groups, with the reported average reductions ranging from around 1.1 to 3.5 points depending on the group and time point measured. The reported data also shows that adverse events (any unexpected medical occurrence during the study, whether or not related to the ointment) were recorded across all groups, though the data as submitted contains multiple figures that are not clearly labelled by event category in the structured results, so a full breakdown cannot be provided here without risk of misrepresenting the numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03706040 · results posted 18 November 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03706040) enrolled 172 adults with atopic eczema (eczema). In the first phase of the trial (the first 16 weeks), participants were randomly assigned to receive either a placebo (an inactive treatment), a 150 mg dose of a medicine called risankizumab, or a 300 mg dose of risankizumab. In the second phase (weeks 16 to 52), participants continued or switched treatments depending on which group they had been in. The trial was primarily measuring how many people's eczema improved significantly — specifically, how many achieved at least a 75% reduction in a standard eczema scoring system called the EASI (a score from 0 to 72, where higher numbers mean worse eczema). The reported data shows that at week 16, around 11.8% of those on placebo, 24.6% on the 150 mg dose, and 21.7% on the 300 mg dose reached that 75% improvement mark. For a secondary measure looking at how a doctor rated overall eczema severity (on a scale of 0 to 4), 5.9% of the placebo group, 14.5% on 150 mg, and 5.8% on 300 mg reached a score of 0 or 1 (meaning "clear" or "almost clear") with at least a 2-point improvement. When it came to participants rating their worst itch in the past 24 hours, 0% of the placebo group, 13.6% on 150 mg, and 15.2% on 300 mg reported a reduction of 4 or more points on an 11-point scale. The reported average change in EASI score at week 16 was a reduction of about 28.5% for placebo, 38.9% for the 150 mg group, and 45.4% for the 300 mg group. In the second phase, the reported data shows further changes in EASI scores and response rates across the different continuation and switch groups at weeks 28 and 52, though the numbers varied considerably between subgroups, some of which were quite small. 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 ↗
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NCT03526861 · results posted 29 October 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03526861) tested a medicine called tralokinumab in young people with atopic dermatitis (eczema). In the first part of the trial (the "initial treatment period"), 101 participants received tralokinumab at a higher dose (300 mg) every two weeks, 100 received a lower dose (150 mg) every two weeks, and 100 received a placebo (a dummy injection with no active medicine). A smaller group of participants then continued into a maintenance phase at varying doses, and 242 participants took part in a later open-label phase where everyone received the higher dose, sometimes alongside a topical cream. The trial was measuring how many participants' skin cleared or nearly cleared after 16 weeks, as well as changes in itch, overall skin severity, and quality of life. The reported data shows that at 16 weeks, 17 out of 101 participants in the higher-dose group and 21 out of 100 in the lower-dose group had skin rated as "clear" or "almost clear" by a doctor, compared with 4 out of 100 in the placebo group. Using a separate skin severity scoring tool (measuring the area and seriousness of eczema), 27 participants in the higher-dose group and 28 in the lower-dose group showed at least a 75% improvement, compared with 6 in the placebo group. For itch, 24 (higher dose) and 22 (lower dose) participants reported a meaningful reduction in their worst itch score, versus 3 in the placebo group. Overall eczema severity scores (on a scale up to 103) dropped by about 29 points in the higher-dose group and 27.5 points in the lower-dose group, compared with about 9.5 points in the placebo group. Quality-of-life scores (on a scale up to 30, where higher means more impact on daily life) fell by about 6.7 and 6.1 points in the two tralokinumab groups respectively, and by about 4.1 points in the placebo group. The reported data also recorded 130, 175, and 134 adverse events (unwanted health events noted during the trial) in the higher-dose, lower-dose, and placebo groups respectively during the initial treatment 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 ↗
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NCT03761537 · results posted 26 October 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03761537) enrolled 277 adults with eczema (also called atopic dermatitis) — 140 in one group and 137 in another. One group received the medicine tralokinumab together with a topical corticosteroid (a steroid cream applied to the skin), while the other group received a placebo (an inactive dummy treatment) together with the same steroid cream. The main thing the trial was measuring was how many people in each group had their eczema severity score (called EASI) reduce by at least 75% after 16 weeks of treatment. By the end of the study, 125 people in the tralokinumab group and 120 in the placebo group had completed the trial. The reported data shows that for the primary measure — at least a 75% improvement in the EASI score at 16 weeks — 64.2% of people in the tralokinumab-plus-steroid-cream group reached that level, compared with 50.5% in the placebo-plus-steroid-cream group. The reported data also shows results for several secondary measures at 16 weeks: when asked to rate their worst itch on a scale of 0–10, 45.5% of the tralokinumab group reported a reduction of at least 4 points, versus 35.6% in the placebo group. A separate eczema scoring tool (SCORAD, out of 103) showed an average decrease of 42.7 points in the tralokinumab group and 34.1 points in the placebo group. A quality-of-life questionnaire (DLQI, out of 30, where higher scores mean worse impact on daily life) showed an average decrease of 11.2 points in the tralokinumab group and 9.6 points in the placebo group. When a doctor rated skin appearance on a 0–4 scale, 40.9% of the tralokinumab group were rated as "clear" or "almost clear" at 16 weeks, compared with 26.0% in the placebo group. At 26 weeks, the reported data shows that 68.8% of people in the tralokinumab group had achieved at least a 75% improvement in their EASI score, compared with 55.3% in the placebo group. No other outcome data beyond what is described above was 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.
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NCT03627767 · results posted 20 September 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,235 people with atopic dermatitis (eczema). All participants started by taking a 200 mg dose of the study medicine (called PF-04965842, also known as abrocitinib) for 12 weeks in an open-label phase — meaning everyone knew what they were taking. Of those, 798 completed that first phase and were then split into three groups for a 40-week blinded phase (where neither participants nor their doctors knew which treatment was being given): one group switched to a dummy pill (placebo), one continued on a lower 100 mg dose, and one stayed on the 200 mg dose. The trial's main question was how many people in each group experienced a return of their eczema symptoms — called a "loss of response" — during the blinded phase. The reported data shows that, for the primary outcome (return of symptoms requiring rescue treatment during the blinded phase), the placebo group had the highest rate at 77.5%, the lower-dose (100 mg) group had a rate of 39.6%, and the group that stayed on the 200 mg dose had the lowest rate at 16.5%. For one of the secondary measures — how many days it took before symptoms returned — the reported median was 27 days for the placebo group, 78 days for the 100 mg group, and 201 days for the 200 mg group. The reported data also shows that at the end of the blinded period (Week 52 from the start of the blinded phase), the percentage of participants whose skin was rated as clear or almost clear by a doctor was approximately 10.6% in the placebo group, 42.3% in the 100 mg group, and 57.1% in the 200 mg group. Similar patterns across timepoints were reported for other skin severity scores measuring the extent and signs of eczema across the body. 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 ↗
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NCT04498403 · results posted 12 August 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT04498403) involved 40 people in total who used a skin ointment called crisaborole 2%. Thirty of the participants were under 18 years old (Cohort 1), and ten were 18 years or older (Cohort 2). The trial was set up to track any unwanted medical events — known as adverse events — that occurred from the first application of the ointment up to 28 days after the last dose. It also looked specifically for any serious adverse events, which are defined as events involving things like hospitalisation, life-threatening situations, or lasting disability. The reported data shows that in the under-18 group, 11 out of 30 participants experienced at least one treatment-emergent adverse event (that is, an unwanted medical occurrence that appeared or got worse after starting the ointment). In the 18-and-over group, 3 out of 10 participants experienced at least one such event. The reported data shows that no serious adverse events were recorded in either group. No other outcome measures were included in the structured results data submitted to ClinicalTrials.gov for this 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.
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NCT03517566 · results posted 20 July 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03517566) enrolled 293 adults with atopic dermatitis (eczema). Participants were randomly assigned to one of five groups: a placebo (inactive treatment) or one of four doses of a medicine called ZPL389 (3 mg, 10 mg, 30 mg, or 50 mg). The trial ran for 16 weeks and was primarily measuring how many people's eczema improved enough to be rated as "clear" or "almost clear" by a doctor using a standard scoring tool called the Investigator's Global Assessment (IGA). Not everyone completed the trial — for example, 42 of the 74 placebo participants finished, and completion numbers were similar across the other groups. The reported data shows that at Week 16, the percentage of participants who met the IGA "clear or almost clear" target was low across all groups: approximately 1.9% in the placebo group, 3.3% in the 3 mg group, 7.2% in the 10 mg group, 0.8% in the 30 mg group, and 6.9% in the 50 mg group. For the secondary measures, a separate eczema scoring tool (EASI, rated 0–72 where higher means worse eczema) showed that all groups — including placebo — reported reductions in their eczema scores over time. At Week 16, the reported percent reductions from the starting score were: placebo –55.0%, ZPL389 3 mg –49.4%, 10 mg –50.7%, 30 mg –46.2%, and 50 mg –52.7%. The reported data also shows that relatively small percentages of participants in any group achieved a 50% or 75% improvement on that same scale by Week 16. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03725722 · results posted 8 July 2021
According to the results reported on ClinicalTrials.gov, this trial looked at a cream called delgocitinib, tested at four different strengths (1, 3, 8, and 20 mg/g), compared against a "vehicle" cream containing no active ingredient. The trial enrolled 251 people in total across the five groups, and measured changes in their eczema (atopic dermatitis) symptoms over 8 weeks. The main thing being measured was a skin scoring system called the EASI, which runs from 0 to 72 — a higher number means more severe or widespread eczema. The reported data shows that after 8 weeks, the average EASI score fell by 5.0 points in the 1 mg/g group, 4.9 points in the 3 mg/g group, 5.8 points in the 8 mg/g group, and 7.6 points in the 20 mg/g group, compared to a fall of 1.9 points in the vehicle (no active ingredient) group. For a secondary measure — the number of participants whose skin was rated "clear" or "almost clear" with a meaningful improvement by a doctor — the reported figures were 9, 14, 15, and 24 participants across the four increasing dose groups respectively, versus 5 participants in the vehicle group. The reported data also shows that 20, 21, 28, and 33 participants in each dose group (compared to 10 in the vehicle group) achieved at least a 75% reduction in their EASI score by week 8. For the time taken to reach a "clear" or "almost clear" rating, the data was not reported for the 3 mg/g and vehicle groups; for the other groups, the reported median times were 64 days for the 1 mg/g group, 64 days for the 8 mg/g group, and 44 days for the 20 mg/g 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 ↗
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NCT03389893 · results posted 14 June 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 72 adults in total — 46 received dupilumab and 26 received a placebo (an inactive dummy injection) during the first, blinded phase of the study, where neither participants nor researchers knew who was getting which treatment. After that phase, participants moved into an open-label extension where everyone received dupilumab. The trial was measuring levels of a bacterium called *Staphylococcus aureus* (a common skin bacterium) on participants' skin, as well as how well the skin barrier was functioning — assessed using a measure called transepidermal water loss (TEWL), which tracks how much water evaporates through the skin. The reported data shows that at Day 28 — the main measurement point — the dupilumab group had a reported average *S. aureus* level on affected skin of approximately 86 relative colony-forming units per square centimetre (a unit used to estimate the amount of bacteria), compared with approximately 2,608 in the placebo group. At earlier and later time points across both phases of the trial, the dupilumab group also had lower reported *S. aureus* counts than the placebo group on both affected and unaffected skin, though once placebo participants switched to dupilumab in the open-label phase, their reported bacterial levels also fell. For the skin barrier measurements (TEWL), the reported figures across the various time points were broadly similar between groups, with the dupilumab group generally recording slightly lower values on affected skin at some time points; for example, at Day 28 the dupilumab group recorded approximately 25 g/m²/hour compared with approximately 32 g/m²/hour 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.
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NCT03796676 · results posted 4 June 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03796676) enrolled 285 adults with atopic dermatitis (eczema) across three groups: 96 received a placebo (inactive treatment), 95 received a 100 mg daily dose of PF-04965842 (abrocitinib), and 94 received a 200 mg daily dose. The trial was primarily measuring two things after 12 weeks: how many participants' skin was rated by a doctor as "clear" or "almost clear" on a standard severity scale, and how many participants saw their eczema area and severity score improve by at least 75% from where it started. The reported data shows that at the 12-week mark, 24.5% of placebo participants, 41.6% of the 100 mg group, and 46.2% of the 200 mg group met the doctor-rated "clear or almost clear" skin goal. For the 75% improvement in eczema area and severity, the figures reported were 41.5% (placebo), 68.5% (100 mg), and 72.0% (200 mg). The trial also measured itch severity using a 0–10 self-reported scale, looking at the proportion of participants whose worst itch score improved by at least 4 points. The reported data shows that by week 12, this was achieved by 29.8% of the placebo group, 52.6% of the 100 mg group, and 55.4% of the 200 mg group. A separate symptom diary score (rated 0–10, where higher means worse) showed average reductions from baseline of 2.0 points (placebo), 2.5 points (100 mg), and 2.7 points (200 mg) at 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00717769 · results posted 21 April 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT00717769) enrolled 270 adults with atopic dermatitis (eczema). Participants were divided into three groups: 120 received a placebo (a dummy treatment with no active ingredient), 120 received a lower dose of an investigational medicine called SUN13834 (50 mg three times a day), and 30 received a higher dose of SUN13834 (200 mg three times a day). The trial measured changes in eczema severity using several scoring tools, the main one being the Eczema Area and Severity Index (EASI) — a scale from 0 (clear skin) to 72 (very severe eczema). By the end of the study, 104 placebo participants, 102 in the lower-dose group, and 19 in the higher-dose group had completed the trial. The reported data shows that at the start of the trial, average EASI scores were similar across the placebo and lower-dose groups (around 12.5 out of 72), while the higher-dose group started with a notably lower average score of about 6 out of 72. Over the course of the study, both the placebo and the lower-dose SUN13834 groups showed reductions in their EASI scores. By the final visit, the placebo group's score had dropped by an average of around 4–5 points, while the lower-dose SUN13834 group's score had dropped by around 7–8 points — roughly a 40–54% reduction compared to around 37–40% in the placebo group, depending on which analysis set was used. A secondary measure — the Investigator's Global Assessment (IGA), a 0–5 scale of overall disease severity rated by a clinician — also showed reductions in both groups by the final visit, with the placebo group dropping by an average of 0.8 points and the lower-dose SUN13834 group dropping by an average of 1.1 points. Results for the higher-dose group were not reported for the change-from-baseline outcome 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.
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NCT03831191 · results posted 20 April 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03831191) enrolled 136 adults with atopic dermatitis (eczema) across four groups during the first 16-week phase: 33 received a placebo (a dummy treatment with no active ingredient), 35 received a 50 mg dose of the investigational drug LY3375880, 34 received 150 mg, and 33 received 600 mg. The trial was measuring how participants' eczema changed across several standardised scoring systems used by doctors to rate things like skin redness, oozing, crusting, the area of skin affected, and self-reported itch and sleep disruption. A smaller number of participants then moved into a 36-week maintenance phase based on how they responded in the first phase. It is worth noting that a large proportion of participants across all groups did not complete the first 16-week period. The reported data shows the following results at the end of the 16-week induction period. For the primary measure — the percentage of participants whose doctor-rated eczema score improved to "clear" or "almost clear" (a score of 0 or 1 on a 5-point scale, with at least a 2-point improvement from the start) — the figures were: 9.5% in the placebo group, 5.0% in the 50 mg group, 5.9% in the 150 mg group, and 4.8% in the 600 mg group. For a separate skin-area-and-severity scoring system (EASI), the percentage of participants who achieved at least a 75% improvement from their starting score was reported as 19.0% for placebo, 15.0% for 50 mg, 23.5% for 150 mg, and 0.0% for 600 mg. On another combined scoring tool (SCORAD), the percentage reaching a 75% improvement was 4.8% for placebo, 5.0% for 50 mg, and 0.0% for both 150 mg and 600 mg. No participant in any group achieved a score of "completely clear" (a score of 0) on the doctor's rating scale. The reported average change in the EASI score from the start of the trial was −11.45 points for placebo, −4.90 for 50 mg, −5.89 for 150 mg, and −7.87 for 600 mg (where a negative number means scores were lower — indicating less severe disease — than at the start). Some secondary outcome data appeared to be truncated in the available records and could not be fully 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.
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NCT03903822 · results posted 29 March 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03903822) enrolled 292 adults with atopic dermatitis (eczema) across eight groups. Participants were randomly assigned to apply either a cream containing different strengths of an investigational medicine called PF-06700841 (at 0.1%, 0.3%, 1.0%, or 3.0%) or a plain "vehicle" cream containing no active ingredient, either once or twice daily for six weeks. The trial was primarily measuring changes in a standard eczema scoring system called the EASI (Eczema Area and Severity Index), which rates the extent and severity of eczema on a scale from 0 to 72, where higher numbers mean more severe disease. The reported data shows that after six weeks, the EASI scores had changed from the starting point by the following amounts: the once-daily vehicle (plain) cream group reported a 44.4% reduction; the once-daily active cream groups reported reductions of 58.3% (0.1%), 64.6% (0.3%), 70.1% (1.0%), and 67.9% (3.0%); the twice-daily vehicle cream group reported a 47.6% reduction; and the twice-daily active cream groups reported reductions of 58.6% (0.3%) and 75.0% (1.0%). For a separate skin-clearance rating (IGA score), the percentage of participants recorded as "clear" or "almost clear" at week six ranged from 10.8% in the once-daily vehicle group up to 44.4% in the once-daily 3.0% active cream group. Secondary measures also tracked the proportion of participants reporting meaningful reductions in itch scores and changes in the body surface area affected by eczema, with the reported data showing variation across the different groups and dose levels. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03758716 · results posted 15 March 2021
According to the results reported on ClinicalTrials.gov, this trial tested a treatment called FB825 and enrolled 12 participants. All 12 completed the study — none dropped out. The trial was measuring changes in certain blood markers linked to allergic reactions, specifically a protein called IgE (a substance the immune system produces in response to allergens). It also tracked two symptom-based scores: one measuring irritability and one measuring a skin condition called eczema (using standard rating scales). The reported data shows that, on average, participants' total IgE levels in the blood fell by around 45.6% from where they started, and their levels of IgE specific to a particular allergen (such as ragweed) fell by around 50.2%. The secondary measurements tracked these IgE levels at multiple points over time, showing a general downward trend in the numbers as the study progressed. For dog dander-specific IgE, the reported change reached approximately −47% by the final time point. The irritability scale score (rated 0–20, where lower is described as better) was reported to have fallen by around 32.6% from baseline, and the eczema severity score (rated 0–72, where lower is described as better) was reported to have fallen by around 44.3% from baseline. It is important to note that this was a small study involving only 12 people and there was no comparison group (for example, a group receiving a dummy treatment), so these numbers reflect what was measured in this one group 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.
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NCT03908970 · results posted 25 January 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03908970) enrolled 364 people in total — 182 received a skin treatment called 1% OPA-15406 (an ointment) and 182 received a placebo (an inactive comparator). The trial was measuring outcomes related to eczema (atopic dermatitis), including an overall skin severity rating by a doctor, the extent and severity of eczema across the body, and the intensity of itch. Of those who started, 165 in the OPA-15406 group and 135 in the placebo group completed the study. The reported data shows that for the main outcome — a doctor's overall rating of skin severity — about 38% of participants in the OPA-15406 group were classed as "responders" (meaning their skin was rated clear or almost clear, and had improved by at least two grade levels from the start), compared with about 13% in the placebo group. For the eczema area and severity score (a scale from 0 to 72, where lower is less severe), the OPA-15406 group had an average change of −4.17 points from the start of the trial, while the placebo group had an average change of −0.08 points — in both cases a negative number indicates some reduction in measured severity. For itch intensity (rated on a 0–3 scale), the reported average change was −0.65 in the OPA-15406 group and −0.04 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.
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NCT03720470 · results posted 19 January 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03720470) enrolled 838 adults with atopic dermatitis (eczema). Participants were assigned to one of four groups for the first 16 weeks: a placebo (dummy treatment) group (131 people), a group taking PF-04965842 (also known as abrocitinib) at a 100 mg daily dose (238 people), a group taking PF-04965842 at a 200 mg daily dose (226 people), or a group receiving dupilumab — an existing injectable eczema medicine used here for comparison — (242 people). The trial was measuring how many participants in each group saw their skin clear up or nearly clear up by week 12, using two standard scoring tools doctors use to rate eczema severity. The reported data shows the following results at week 12 for the two main (primary) measures. For the first measure — the proportion of people whose skin was rated "clear" or "almost clear" by a doctor — 14% of the placebo group reached that mark, compared with 36.6% in the 100 mg abrocitinib group, 48.4% in the 200 mg abrocitinib group, and 36.5% in the dupilumab group. For the second main measure — the proportion of people whose overall eczema severity score (covering redness, skin thickening, scratching marks and skin texture across the body) improved by at least 75% from where it started — 27.1% of the placebo group reached that level, compared with 58.7% in the 100 mg abrocitinib group, 70.3% in the 200 mg abrocitinib group, and 58.1% in the dupilumab group. Additional measures tracked itching scores and skin severity scores at earlier and later time points; the reported data shows broadly similar patterns across those time points, with the 200 mg abrocitinib group generally recording the highest percentages. 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 ↗
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NCT03864627 · results posted 5 January 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 33 people in total — 11 received a placebo (an inactive treatment used for comparison) and 22 received MOR106 at a dose of 320 mg. Of those who started, 7 out of 11 in the placebo group and 10 out of 22 in the MOR106 group completed the study. The trial was measuring safety-related events, how much of the drug was present in participants' blood over time, and whether participants developed antibodies against the drug (which can sometimes affect how a drug behaves in the body). The reported data shows that treatment-emergent adverse events (that is, unwanted medical occurrences that appeared after starting the study treatment) were recorded in 5 out of 11 placebo participants and 11 out of 22 MOR106 participants. Adverse events of special interest — a specific category covering certain skin-related events or severe injection-site reactions — were reported in 2 placebo participants and 1 MOR106 participant. Serious adverse events (those considered potentially life-threatening, requiring hospitalisation, or similarly severe) were reported in 0 placebo participants and 1 MOR106 participant. No deaths were reported in either group. Regarding the drug's presence in the blood, the reported data shows MOR106 levels rose after dosing and then gradually fell over time, with concentrations measured at various points ranging from around 0.149 to 61.150 micrograms per millilitre across the follow-up period. No participants in either group were found to have developed antibodies against the drug. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01591785 · results posted 3 December 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total — 30 received a treatment ointment called retapamulin 1%, and 30 received a placebo (a dummy ointment with no active ingredient). The trial was looking at a skin condition called atopic dermatitis (a type of eczema) and its possible link to a common bacterium called *Staphylococcus aureus* (*S. aureus*). Doctors rated each participant's skin condition using a scale called the Physician's Global Assessment (PGA), where a score of 0 means the skin appears completely clear and a score of 1 means almost clear. The reported data shows that at day 15, 22 out of 30 participants in the retapamulin group had a PGA score of 0 or 1, compared with 14 out of 30 in the placebo group. At day 28, the reported numbers were 15 out of 30 in the retapamulin group and 11 out of 30 in the placebo group. For the secondary measure — which looked at whether participants also had negative bacterial culture tests (meaning *S. aureus* was not detected on the skin or in the nose) at the same time as a clear or almost-clear skin score — the reported data shows that at day 15, 61% of the retapamulin group met this combined result compared with 30% of the placebo group. At day 28, those figures were 28% for the retapamulin group and 13% 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03160885 · results posted 24 August 2020
According to the results reported on ClinicalTrials.gov, this trial tested an injection called tralokinumab (given every two weeks) against a dummy injection (placebo) in adults with atopic dermatitis — a type of eczema. The trial ran in several phases: an initial 16-week period where 593 people received tralokinumab and 201 received placebo; a later maintenance period involving smaller groups; and an open-label phase where 560 participants all received tralokinumab. The trial was measuring changes in skin appearance, itch, and quality of life over time. The reported data shows that at 16 weeks, 131 out of 593 people in the tralokinumab group had skin rated as "clear" or "almost clear" by a doctor (using a 0–4 scale), compared with 22 out of 201 in the placebo group. Separately, 196 people in the tralokinumab group achieved at least a 75% reduction on a standard eczema severity scoring tool (the EASI), compared with 23 in the placebo group. For itch — measured on a 0–10 scale — 144 people receiving tralokinumab reported at least a 4-point reduction in their worst daily itch score, compared with 19 in the placebo group. On a broader eczema severity score (SCORAD, out of 103), the tralokinumab group's average score fell by 28.1 points from their starting point, while the placebo group's fell by 14.0 points. For quality of life (a skin-specific questionnaire scored 0–30, where lower is better), the tralokinumab group's average score fell by 8.8 points, compared with 4.9 points in the placebo group. In the maintenance phase, among those who had already achieved clear or almost-clear skin at week 16, the reported data shows that 32 out of 91 people continuing tralokinumab every two weeks still had clear or almost-clear skin at week 52, as did 22 out of 90 receiving it every four weeks, and 7 out of 46 who had switched to 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 ↗
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NCT02755649 · results posted 20 August 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 325 adults across three groups: 108 received a placebo injection once a week plus a topical cream (steroid cream applied to the skin); 107 received dupilumab (a medicine given by injection) every two weeks plus the topical cream; and 110 received dupilumab every week plus the topical cream. The trial was measuring changes in eczema severity over 16 weeks, using several scoring tools that assess things like redness, skin thickening, scratching damage, and itch. It is worth noting that while most participants completed the 16-week treatment phase, very few — around 7–8 per group — remained in the study through to the final 28-week check-in. The reported data shows that the main thing being measured was how many participants achieved at least a 75% improvement in their eczema severity score (called EASI-75) by week 16. In the placebo-plus-cream group, 29.6% of participants reached that level of improvement. In the dupilumab-every-two-weeks group, 62.6% reached it, and in the dupilumab-every-week group, 59.1% reached it. For the secondary measures, the reported data shows the overall eczema severity score (EASI) fell by an average of 46.6% from the starting point in the placebo group, compared with 79.8% and 78.2% in the two dupilumab groups. A separate eczema severity tool (SCORAD, scored 0–103) showed average reductions of 29.5%, 62.4%, and 58.3% respectively. For itch — rated by participants on a 0–10 scale — the average peak itch score fell by 25.4% in the placebo group, and by 53.9% and 51.7% in the two dupilumab groups. The proportion of participants whose itch score dropped by 4 or more points was 14.3% in the placebo group, 45.7% in the every-two-weeks dupilumab group, and 40.4% in the every-week dupilumab group. The reported data also shows that the area of skin affected by eczema decreased by an average of about 19.6 percentage points in the placebo group, and by about 39.2 and 37.5 percentage points in the two dupilumab 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 ↗
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NCT03733301 · results posted 11 August 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03733301) enrolled 329 people with atopic dermatitis (eczema) across three groups: 109 received a placebo (a dummy treatment with no active ingredient), 109 received a 2 mg daily dose of baricitinib, and 111 received a 4 mg daily dose of baricitinib. The trial was primarily measuring how many participants' skin cleared or nearly cleared according to a doctor's rating scale, as well as a number of secondary measures looking at skin severity scores and itch levels. The reported data shows that for the main outcome — the proportion of participants whose skin was rated as clear or almost clear by their doctor, with a meaningful improvement from their starting point — 14.7% of the placebo group, 23.9% of the 2 mg baricitinib group, and 30.6% of the 4 mg baricitinib group reached that level. For the secondary outcomes, the reported data shows that 22.9% of the placebo group, 43.1% of the 2 mg group, and 47.7% of the 4 mg group achieved at least a 75% improvement in a detailed skin severity score (EASI75). A higher bar of 90% improvement in that same score (EASI90) was reached by 13.8%, 16.5%, and 24.3% respectively. The overall skin severity score was reported to have reduced from the starting point by around 45% in the placebo group, 58% in the 2 mg group, and 67% in the 4 mg group. For itch specifically, 20.2% of the placebo group, 38.1% of the 2 mg group, and 44.0% of the 4 mg group reported a meaningful reduction in their worst daily itch 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02925117 · results posted 16 July 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02925117) looked at upadacitinib — a medicine taken as a daily tablet — in people with moderate-to-severe atopic dermatitis (eczema). The trial had two periods. In the first period (weeks 0 to 16), 167 people were assigned to one of four groups: placebo (a dummy tablet with no active medicine), upadacitinib 7.5 mg, 15 mg, or 30 mg. After week 16, participants moved into a longer second period running to week 88, where some groups continued, stopped, or switched treatment. The trial measured changes in eczema severity using several scoring tools, with the main measure being a scoring system called EASI (which rates the area of skin affected and how severe the eczema signs are, on a scale of 0 to 72, where higher means worse). The reported data shows the following for the main measure — the percentage change in EASI score from the start to week 16. The placebo group showed a 23.0% reduction, the 7.5 mg group showed a 39.4% reduction, the 15 mg group showed a 61.7% reduction, and the 30 mg group showed a 74.4% reduction. For one of the secondary measures, the proportion of participants whose EASI score dropped by at least 75% (a commonly used benchmark) by week 16 was reported as: 9.8% in the placebo group, 28.6% in the 7.5 mg group, 52.4% in the 15 mg group, and 69.0% in the 30 mg group. The reported data also shows that the proportion of participants rated by a clinician as having skin that was "clear" or "almost clear" at week 16 was 2.4% (placebo), 14.3% (7.5 mg), 31.0% (15 mg), and 50.0% (30 mg). For the itch score (rated 0–10 by participants), the reported data shows that by week 16 the placebo group's score had changed by −9.7%, while the 7.5 mg, 15 mg, and 30 mg groups showed changes of −39.6%, −48.0%, and −68.9% respectively. Similar patterns in the direction of change were also reported at the earlier week 2 and week 8 time points, and in a separate overall eczema scoring tool called SCORAD. 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 ↗
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NCT02210780 · results posted 7 May 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 194 adults in total — 97 who received a weekly placebo injection and 97 who received a weekly 300 mg dose of dupilumab (a medicine being studied for eczema, also known as atopic dermatitis). The trial was primarily measuring whether dupilumab affected how well participants' immune systems responded to two vaccines — a tetanus booster (Tdap) and a meningococcal vaccine (Menomune) — given during the study. Secondary measures looked at how participants' eczema changed over 16 weeks using standard skin assessment tools. The reported data shows that, for the main (primary) outcome — having a strong antibody response (a fourfold or greater increase in tetanus antibody levels) to the tetanus vaccine by week 16 — 83.7% of the placebo group and 83.3% of the dupilumab group met this threshold. For a slightly lower bar (a twofold or greater increase), the figures were 94.6% and 95.6% respectively. For the meningococcal vaccine response, 87.0% of the placebo group and 86.7% of the dupilumab group reached the defined threshold. The trial was not designed to formally test whether any difference between the two groups was statistically meaningful, so no such comparison was performed. The reported data also shows differences in eczema-related outcomes at week 16. On a doctor's overall skin-clearance rating (IGA), 10.3% of placebo participants and 44.3% of dupilumab participants were rated as "clear" or "almost clear." Using a detailed eczema scoring tool (EASI), 32.0% of the placebo group versus 72.2% of the dupilumab group showed at least a 50% improvement from their starting score, and 19.6% versus 53.6% showed at least a 75% 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03575871 · results posted 21 April 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03575871) tested two doses of a medicine called PF-04965842 (100 mg and 200 mg, taken daily by mouth) against a placebo (a dummy pill with no active ingredient) in people with moderate-to-severe atopic dermatitis, commonly known as eczema. A total of 391 people took part — 158 in the 100 mg group, 155 in the 200 mg group, and 78 in the placebo group. The trial ran for 12 weeks and measured things like how clear participants' skin looked to a doctor, how much of the body was affected by eczema, and how badly participants felt they were itching. The reported data shows that at week 12, 28.4% of participants in the 100 mg group and 38.1% in the 200 mg group had skin that a doctor rated as "clear" or "almost clear" (and at least two points better than when they started), compared with 9.1% in the placebo group. Using a separate body-coverage score (called EASI-75, meaning at least a 75% improvement in how much of the body was affected), 44.5% of the 100 mg group and 61.0% of the 200 mg group reached that threshold at week 12, compared with 10.4% in the placebo group. For itching, participants rated their worst itch on a scale of 0–10; the reported data shows that at week 12, around 39.7% (100 mg) and 49.0% (200 mg) of participants reported at least a 4-point drop in their itch score, compared with 10.5% in the placebo group. The reported data also shows that participants' self-rated symptom scores (covering 11 skin symptoms scored 0–10) fell on average by 2.4 points in the 100 mg group and 3.0 points in the 200 mg group from where they started, compared with a 0.8-point fall in the placebo group. The median time to reach a meaningful drop in itch score was reported as 58 days for the 100 mg group and 29 days for the 200 mg group; for the placebo group this figure was 112 days, though it is worth noting that not all participants in every group reached that threshold during 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 ↗
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NCT01979016 · results posted 18 March 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT01979016) looked at dupilumab (given as a 200 mg weekly injection) compared to a placebo (an inactive injection) in adults with atopic dermatitis, commonly known as eczema. A total of 54 people took part — 27 in the placebo group and 27 in the dupilumab group. The main thing being measured was how much the severity of participants' eczema changed over 16 weeks, using a standardised scoring tool called the EASI (Eczema Area and Severity Index), which rates eczema from 0 (no eczema) to 72 (most severe). The reported data shows that, after 16 weeks, participants in the placebo group had an average reduction in their EASI score of about 5.8%, while participants in the dupilumab group had an average reduction of about 75.2%. For the secondary measures, the reported data shows that 0% of placebo participants and 37% of dupilumab participants reached a skin assessment rating of "clear" or "almost clear" on the doctors' global assessment scale. About 3.7% of placebo participants and 51.9% of dupilumab participants showed a meaningful improvement (a drop of 2 or more points) on that same scale. For self-reported itch intensity (rated 0–10), the placebo group reported an average reduction of around 1 point, while the dupilumab group reported an average reduction of around 3.6 points — a percentage change of roughly 8% versus 56%, 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 ↗
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NCT03334422 · results posted 22 January 2020
According to the results reported on ClinicalTrials.gov, this trial looked at baricitinib — a tablet taken once daily — as a treatment for atopic dermatitis (eczema) in adults. A total of 615 people took part across four groups: 244 received a placebo (a dummy pill with no active ingredient), 125 received 1 mg of baricitinib, 123 received 2 mg, and 123 received 4 mg. The trial measured how participants' skin changed over time using several standardised scoring tools that doctors use to rate the extent and severity of eczema. The reported data shows the following for the main outcome — the proportion of participants whose skin was rated by a doctor as nearly clear or clear, and who had improved by at least 2 points on a 5-point scale: 4.5% of the placebo group reached this point, compared with 10.6% in the 2 mg group and 13.8% in the 4 mg group. For the secondary outcomes, the reported data shows that when looking at a 75% improvement in a separate eczema severity score (EASI75), 6.1% of the placebo group reached this level, versus 12.8% (1 mg), 17.9% (2 mg), and 21.1% (4 mg). For a 90% improvement on the same scale (EASI90), the figures were 2.5% (placebo), 6.4% (1 mg), 8.9% (2 mg), and 13.0% (4 mg). On another scoring tool (SCORAD75, measuring a 75% improvement), 1.6% of the placebo group reached that threshold, compared with 4.8%, 7.3%, and 11.4% across the three baricitinib doses respectively. The average percentage change in eczema severity scores from the start of the trial was also reported: −28.9% for the placebo group, −41.7% for the 1 mg group, and approximately −54.8% for both the 2 mg and 4 mg 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 ↗
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NCT01393158 · results posted 14 January 2020
According to the results reported on ClinicalTrials.gov, this trial looked at two different doses of a medicine called apremilast — 20 mg and 30 mg, each taken twice daily — in people with atopic dermatitis (eczema). A total of 16 people took part: 6 in the 20 mg group and 10 in the 30 mg group. The trial measured changes in eczema severity, itch, and quality of life over time — three months for the 20 mg group and six months for the 30 mg group. The reported data shows that the main measure used was the EASI score, a 0–72 scale that combines the area of skin affected with how severe the eczema signs are (higher scores mean more severe disease). The 20 mg group's average EASI score changed by −8.8 points from the start, and the 30 mg group's changed by −8.2 points — meaning both groups had lower scores at the end of the study than at the beginning. For itch (measured on a 0–100 scale, where higher means worse), the reported change was −32.2 points in the 20 mg group and −13.4 points in the 30 mg group. For quality of life (a 0–30 scale measuring how much skin disease affected daily life), the reported change was −8.3 points in the 20 mg group and −6.3 points in the 30 mg group — again, lower scores at the end than at the start. A separate overall severity rating by the treating doctor (on a 0–5 scale) was also recorded for each participant at the end of the study, though a detailed breakdown of those individual category counts was not clearly separable from the data as reported. It is worth noting that this was a very small trial — only 16 people in total — and the two groups were followed for different lengths of time, so the numbers between groups are not directly comparable. 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 ↗
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NCT03349060 · results posted 10 December 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT03349060) enrolled 387 adults with atopic dermatitis (eczema). Participants were randomly assigned to one of three groups: a daily 100 mg dose of the study drug PF-04965842 (156 people), a daily 200 mg dose (154 people), or a placebo — a dummy pill with no active ingredient (77 people). The trial ran for 12 weeks and was measuring changes in skin appearance and itch severity using several standardised rating scales. The reported data shows the following for the two main outcomes measured at week 12. On a skin clearance scale called the IGA — where doctors rated overall skin condition from 0 (clear) to 4 (severe) — 23.7% of participants in the 100 mg group and 43.8% in the 200 mg group were rated as "clear" or "almost clear," compared with 7.9% in the placebo group. On a separate body-wide skin severity score called the EASI, 39.7% of the 100 mg group and 62.7% of the 200 mg group showed at least a 75% improvement in their score from the start of the trial, compared with 11.8% in the placebo group. For itching, the reported data shows that by week 12, 37.7% of the 100 mg group and 57.2% of the 200 mg group reported at least a 4-point improvement on a 0–10 itch scale, compared with 15.3% in the placebo group. A broader symptom diary covering 11 skin complaints (scored 0–10) showed average score reductions of 2.2 points (100 mg group), 3.2 points (200 mg group), and 1.1 points (placebo group) from the start to 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03100344 · results posted 22 October 2019
According to the results reported on ClinicalTrials.gov, this trial looked at nemolizumab — a medicine given by injection — in people with atopic dermatitis (eczema). A total of 226 people took part, split into four groups: 57 received a placebo (a dummy injection with no active medicine), 55 received a 10 mg dose of nemolizumab, 57 received a 30 mg dose, and 57 received a 90 mg dose. The trial ran for 24 weeks. The main thing researchers were measuring was the change in a standard eczema severity score called EASI (which rates redness, skin thickening, scratching marks, and skin hardening across four body areas on a scale of 0 to 72, where higher means worse). Secondary measurements included itch intensity, sleep disruption, and another overall eczema score called SCORAD. The reported data shows that, by week 24, the EASI score had changed from the starting point by an average of −58.4% in the placebo group, −72.2% in the 10 mg nemolizumab group, −73.4% in the 30 mg group, and −69.2% in the 90 mg group (negative numbers mean the score went down from where it started). For the itch scale (called PCS), the number of participants whose itch reached the "none to mild" range at week 24 was 13 out of 57 in the placebo group, 23 out of 55 in the 10 mg group, 31 out of 57 in the 30 mg group, and 20 out of 57 in the 90 mg group. The reported data shows that the overall eczema score SCORAD also changed from the starting point — by −42.6% for placebo, −60.8% for the 10 mg group, −62.5% for the 30 mg group, and −55.9% for the 90 mg group. For sleep disruption (rated on a 0–10 scale), the reported percentage changes from the starting point were −50.7% for placebo, −75.4% for 10 mg, −76.2% for 30 mg, and −74.9% for 90 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01037881 · results posted 14 October 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 183 adults across seven groups to test different strengths of an experimental cream called LEO 29102 for atopic dermatitis (eczema). The seven groups were: a vehicle cream (containing no active ingredient, used as a comparison), five different strengths of LEO 29102 (0.03, 0.1, 0.3, 1.0, and 2.5 mg/g), and an already-approved cream called Elidel® (10 mg/g), also used as a comparison. The main thing being measured was the change in a standardised eczema severity score called the EASI, which runs from 0 (no eczema signs) to 12 (most severe), with lower scores being better. The trial also looked at secondary measures including how many participants were rated as nearly or completely clear of symptoms by their doctor, and how participants themselves rated their itching and overall disease severity. The reported data shows that all groups had lower — that is, improved — EASI scores by the end of the trial compared to where they started. The vehicle (no active ingredient) group's score decreased by 0.85 points on average. Among the LEO 29102 groups, the reported average decreases ranged from 1.09 points (0.1 mg/g strength) up to 2.50 points (2.5 mg/g strength). The Elidel® comparison group showed an average decrease of 3.30 points. For the secondary measure of being rated "clear" or "almost clear" by their doctor at the end of treatment, the reported numbers of participants meeting that threshold were: 6 in the vehicle group, 2 in the 0.03 mg/g group, 5 in the 0.1 mg/g group, 9 in the 0.3 mg/g group, 10 in the 1.0 mg/g group, 13 in the 2.5 mg/g group, and 12 in the Elidel® group. Some secondary outcome data appeared incomplete in the submitted results, so not all figures across all groups and time points were 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.
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NCT03356977 · results posted 10 October 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 137 infants and young children who used a 2% crisaborole topical ointment (applied to the skin) for eczema. Of those, 132 completed the trial and 5 did not. Because this was a single-group study — meaning everyone received the same treatment with no comparison group — the trial was focused on monitoring and recording participants' health measurements over the study period, including any unwanted medical events, and tracking physical measurements such as height, weight, blood pressure, pulse, and breathing rate. The reported data shows that 88 out of 137 participants experienced at least one treatment-emergent adverse event (that is, an undesirable medical occurrence that appeared or got worse after starting the ointment and within 28 days of finishing it). One participant experienced a serious adverse event, defined as a medically significant event such as hospitalisation or a life-threatening situation. Fifteen participants had a reaction at the spot on the skin where the ointment was applied. Regarding physical measurements, no participants fell below the pre-set lower thresholds for height or weight, while 3 participants exceeded the upper threshold for each. For blood pressure, small numbers of participants met pre-defined thresholds for notable increases or decreases in both the upper (systolic) and lower (diastolic) readings, ranging from 3 to 18 participants depending on the specific measure. Twelve participants had a pulse rate recorded below 90 beats per minute (the pre-defined lower threshold), and none exceeded the upper threshold. For breathing rate, 17 participants fell below the pre-defined lower threshold and 4 exceeded the upper 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 ↗
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NCT03054428 · results posted 23 July 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 251 adults across three groups: 85 received a placebo (inactive injection), 84 received dupilumab at a dose of 300 mg every four weeks, and 82 received dupilumab at a dose of 200 mg or 300 mg every two weeks. The trial was measuring changes in eczema (atopic dermatitis) severity over 16 weeks, using two main scoring tools: a doctor's overall rating of skin clearance (called the IGA, on a scale from 0 "clear" to 4 "severe"), and a detailed skin assessment covering redness, thickness, scratching marks, and skin texture across the body (called the EASI score, from 0 to 72). The reported data shows that for the first main measure — the proportion of participants whose skin was rated "clear" or "almost clear" by the doctor at week 16 — 2.4% of the placebo group reached that level, compared with 17.9% in the four-weekly dupilumab group and 24.4% in the two-weekly dupilumab group. For the second main measure — the proportion of participants whose EASI skin score improved by 75% or more from the start — 8.2% of the placebo group reached this, compared with 38.1% and 41.5% in the two dupilumab groups respectively. For the secondary measures, the reported data shows the average EASI score fell by about 24% from the starting point in the placebo group, versus around 65% in both dupilumab groups by week 16. On the itch scale (rated 0–10 by participants themselves), the average itch score fell by about 19% in the placebo group compared with approximately 46–48% in the dupilumab groups. When looking at the proportion of participants whose itch score dropped by at least 3 points, the figures were 9.4% (placebo), 38.6% (four-weekly dupilumab), and 48.8% (two-weekly dupilumab); for a drop of at least 4 points, the figures were 4.8%, 26.5%, and 36.6% 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 ↗
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NCT02594098 · results posted 12 June 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02594098) enrolled 41 people in total — 27 in the secukinumab group and 14 in a group that started on placebo before switching to secukinumab. Participants had atopic dermatitis (eczema) and were further divided based on their type of the condition — "extrinsic" or "intrinsic." The trial was mainly looking at changes in the thickness of the outer layer of affected skin (the epidermis) after 16 weeks of treatment, as one way of measuring how the skin was responding at a biological level. It is worth noting that only 2 of the 41 participants were recorded as having completed the study. The reported data shows that for the primary measure — change in skin thickness at week 16 compared to the start — the fold-change figures (a way of expressing how much something multiplied or divided relative to a starting point, where 1.0 means no change) were modest across most groups: 1.15 for the placebo-then-secukinumab extrinsic group, 1.5 for the placebo-then-secukinumab intrinsic group, and 1.18 for the secukinumab-only extrinsic group. The secukinumab-only intrinsic group recorded a value of -1, meaning a slight decrease. For the secondary skin marker measures and symptom scores, the reported numbers were also generally small. On the SCORAD symptom scale (0–103, higher meaning more symptoms), the percentage changes at week 16 ranged from about -3% to -27% across the four groups. Very few participants reached the threshold of a 50% improvement on the SCORAD or EASI severity scales at any measured time point, and only one participant across all groups was recorded as achieving the top "clear or almost clear" rating on the investigator's global assessment. The reported data shows that, given the very small number of participants who completed the study, these figures should be interpreted with considerable caution. The results as submitted reflect a relatively small and incomplete dataset, and several outcome details were not fully reported for all 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.
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NCT02871479 · results posted 29 May 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 71 people in total across three groups: 36 people used SAN007 5% cream, 24 people used a placebo (dummy) cream containing no active ingredient, and 11 people used SAN007 10% cream. The trial was measuring two things: first, how many participants experienced any unwanted or unexpected health events (called adverse events) while using the creams; and second, how many participants saw a meaningful improvement in their eczema symptoms, as measured by a standard scoring tool called the Eczema Area and Severity Index (EASI), which rates eczema severity on a scale from 0 (clear skin) to 72 (most severe). The reported data shows that when it came to adverse events, 7 out of 36 participants in the SAN007 5% cream group, 5 out of 24 in the placebo group, and 1 out of 11 in the SAN007 10% cream group experienced at least one such event during the trial. For the secondary measure — the number of participants whose EASI eczema score dropped by 50% or more at any point during the trial — the reported figures were 17 out of 36 in the SAN007 5% cream group, 12 out of 24 in the placebo group, and 6 out of 11 in the SAN007 10% cream group. The trial did not report what caused any of the adverse events, and no further breakdown of these numbers was 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.
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NCT01375205 · results posted 12 April 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 100 babies in total — 54 in the Cetaphil Restoraderm moisturiser group and 46 in the Standard of Care group. The trial was looking at whether regularly applying a specific moisturiser to high-risk infants (those with a family history of eczema or allergies) from early in life might be linked to differences in how many children went on to develop atopic dermatitis (eczema) by 12 months of age. Not all participants completed the trial — 33 finished in each group, meaning 21 and 13 dropped out respectively. The reported data shows that by 12 months, 13.2% of children in the Cetaphil Restoraderm group were diagnosed with atopic dermatitis by the study doctor, compared with 25% in the Standard of Care group. For the secondary measurements, the Cetaphil Restoraderm group reported higher rates of "high use" of their moisturiser (applying it five or more days per week) at earlier time points — starting at 87% — compared with around 45% in the Standard of Care group, though these figures came closer together over time. The reported data shows that the average age when eczema first appeared was 4 months in the Cetaphil Restoraderm group and 6 months in the Standard of Care group. Skin water loss (a measure of how well the skin holds moisture in) and skin hydration readings were also recorded at multiple time points, with figures reported in both groups across the study period — for example, skin water loss readings of 16.3 and 18.3 at the first time point, narrowing at later points. A gene variation called a filaggrin mutation (which affects the skin's natural barrier) was also checked; 3 children in the Cetaphil Restoraderm group and 2 in the Standard of Care group carried this variation, while 22 and 29 respectively did not carry it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02317276 · results posted 24 January 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02317276) enrolled 11 participants, all placed in a single treatment group receiving a topical corticosteroid (a cream or ointment applied to the skin) for atopic dermatitis, which is a type of eczema. The trial was measuring changes in certain biological markers — substances found in the blood and skin tissue — before and after treatment. These markers included eosinophils (a type of immune cell), IgE (an immune protein), and several chemical messengers involved in inflammation (IL-13, CCL-13, and CCL-17). Of the 11 people who started the trial, 5 completed it and 6 did not. The reported data shows that, unfortunately, no numerical results were submitted to ClinicalTrials.gov for the primary outcome measure. This means the actual changes in the blood and tissue marker levels — the central thing the trial set out to measure — were not reported in the structured results data. It is not possible to describe what the numbers showed, because those figures were not 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 ↗
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NCT00316602 · results posted 9 January 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 282 healthy participants and 350 participants with a skin condition called atopic dermatitis (a chronic inflammatory skin condition). Of those who started, 272 healthy participants and 325 atopic dermatitis participants completed the study. The trial was measuring how the body's immune system responded to a vaccine candidate (MVA-BN) — specifically, whether participants developed detectable levels of antibodies (proteins the immune system makes in response to a vaccine) after receiving it. The reported data shows that the main result being tracked was "seroconversion" — that is, whether a person's antibody levels reached a certain detectable threshold or doubled from their starting level after vaccination. Using a laboratory test called ELISA, seroconversion was reported in 98.5% of healthy participants and 97.3% of atopic dermatitis participants. A second type of antibody test (PRNT, which measures a slightly different aspect of the immune response) showed seroconversion in 86.6% of healthy participants and 90.3% of atopic dermatitis participants at what appeared to be the peak timepoint reported in the data. The reported data also includes measurements of the average antibody levels across multiple time points, which generally rose after vaccination and then declined over time in both groups, following a similar pattern in both healthy and atopic dermatitis participants. The reported data also includes a separate measure of immune response involving specialised immune cells (not just antibodies), with figures in the range of 107–334 units per million cells recorded across timepoints for both groups, though the trial report does not provide enough detail in the submitted data to describe exactly when each of these measurements 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02945657 · results posted 19 November 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 32 participants who all received a topical (applied to the skin) ointment called MM36 at a 1% concentration. The trial was measuring how much of the MM36 substance was absorbed into the bloodstream after applying the ointment to the skin — this type of testing is called a pharmacokinetics study, meaning it tracks how a substance moves through the body over time. Of the 32 people who started, 28 completed the study and 4 did not. The reported data shows three main things were tracked in the blood: the highest level of MM36 reached (called the "peak concentration"), how long it took to reach that peak, and the overall amount of MM36 in the blood over time (a rough measure of total exposure). On the first day of use, the reported peak blood level of MM36 was 23.1 nanograms per millilitre (a very small unit of measurement), and it took about 4.2 hours to reach that peak. After two weeks of applying the ointment twice daily, the reported peak blood level was 16.9 nanograms per millilitre, reached at around 3.8 hours. The reported measure of overall blood exposure on Day 1 was 107 ng·hr/mL, and after two weeks it was 86.2 ng·hr/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.
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NCT01548404 · results posted 10 August 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 109 adults with atopic dermatitis (eczema) — 54 received a placebo (inactive) injection and 55 received dupilumab 300 mg. The trial ran for 12 weeks and was mainly measuring changes in eczema severity using a scoring tool called the EASI (Eczema Area and Severity Index), which rates skin symptoms on a scale from 0 to 72, where higher numbers mean more severe eczema. By the end of the study, 24 of the 54 placebo participants and 41 of the 55 dupilumab participants had completed the trial. The reported data shows that, by week 12, the placebo group's EASI score had fallen by an average of 23.3% from where it started, while the dupilumab group's score had fallen by an average of 74.0%. In terms of actual points on the 0–72 scale, the placebo group's score dropped by about 6.4 points on average, compared to about 19.9 points for the dupilumab group. The reported data also shows that 85.5% of dupilumab participants had their EASI score cut by at least half, compared to 35.2% in the placebo group. A separate skin assessment by a doctor (rated 0–4, where 0 means clear and 1 means almost clear) found that 40.0% of the dupilumab group reached a score of 0 or 1 by week 12, compared to 7.4% in the placebo group. The body surface area covered by eczema also changed — the placebo group saw an average reduction of 9.0 percentage points, while the dupilumab group saw an average reduction of 27.4 percentage 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 ↗
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NCT02525094 · results posted 15 February 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02525094) enrolled 113 adults with eczema (also called atopic dermatitis) — 57 in the placebo group and 56 receiving a medicine called MEDI9929 (280 mg). The trial's main goal was to measure how many participants had at least a 50% reduction in their eczema severity score (using a tool called the EASI, which rates redness, skin thickening, scratching marks, and skin texture across different body areas on a scale of 0 to 72) after 12 weeks of treatment. The reported data shows that for the primary measure — the proportion of participants whose EASI score dropped by at least 50% by week 12 — 48.2% of those in the placebo group and 64.7% of those in the MEDI9929 group met that threshold. For the secondary measures, the proportion achieving a 75% or greater EASI reduction was 19.8% (placebo) and 24.4% (MEDI9929). The reported data also shows that average EASI scores fell by around 11.2 points in the placebo group and 12.2 points in the MEDI9929 group from their starting values. On a separate severity scale called SCORAD (ranging 0–103), average scores dropped by about 19.4 points in the placebo group and 24.2 points in the MEDI9929 group. Around 29.4% of placebo participants and 41.0% of MEDI9929 participants achieved a 50% or greater reduction on the SCORAD. For an overall skin-clearance rating made by the investigator (a 0–4 scale), 12.8% of the placebo group and 19.3% of the MEDI9929 group were rated as "clear" or "almost clear" 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.
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NCT02260986 · results posted 17 October 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 740 adults across three groups: 315 received a placebo (dummy injection) every week, 106 received dupilumab 300 mg every two weeks, and 319 received dupilumab 300 mg every week. The trial was measuring outcomes in people with atopic dermatitis (eczema) over 52 weeks, looking at skin clearance, eczema severity, and itch levels at various time points. The reported data shows that for the main (primary) outcome at Week 16 — the proportion of participants whose skin was rated "clear" or "almost clear" by a doctor, and who had improved by at least 2 steps on a 5-point severity scale — 12.4% of the placebo group reached that point, compared with 38.7% in the every-two-weeks dupilumab group and 39.2% in the every-week dupilumab group. For a separate skin severity score (EASI-75, meaning at least a 75% improvement in a detailed eczema scoring system), the reported figures at Week 16 were 23.2% for placebo, 68.9% for the every-two-weeks group, and 63.9% for the every-week group. Regarding itch — measured on a 0–10 self-reported scale — the proportion of participants reporting a reduction of at least 4 points at Week 16 was 19.7% (placebo), 58.8% (every two weeks), and 50.8% (every week). At Week 52, the skin clearance and EASI-75 figures followed a similar pattern, with placebo sitting around 12–22% and both dupilumab groups sitting between roughly 36–65%, 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 ↗
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NCT00806221 · results posted 11 July 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 22 people, all of whom were in a single group that received an emollient (a moisturising skin product). The trial was measuring three main things: whether participants experienced skin irritation, whether they developed a skin infection, and whether they were able to follow the study's instructions as required. A secondary question the trial tracked was whether participants went on to develop eczema (a common skin condition involving redness and itching). The reported data shows that out of the 22 people who started, 20 completed the trial and 2 did not finish. Of the three primary measures, the reported numbers show that zero participants experienced skin irritation, and zero participants developed a skin infection. All 20 people who completed the trial were recorded as having followed the study protocol as required. For the secondary measure, the reported data shows that 5 participants were recorded as developing eczema during the course of the trial. It is worth noting that this trial had only one group — there was no separate comparison group — so the numbers above describe only what was observed in the emollient group alone, with no direct comparison to a group that did not receive the product. The data for any other details about how the trial was designed or what the broader conclusions were was not reported in the structured results 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.
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NCT02347176 · results posted 7 June 2017
According to the results reported on ClinicalTrials.gov, this trial involved 204 adults with eczema (also called atopic dermatitis), split across four groups: 51 received a placebo (inactive treatment), and the remaining 153 received one of three different doses of a medicine called tralokinumab. The trial ran for 12 weeks and was mainly measuring two things: how much participants' eczema severity scores changed on a standard scale called EASI (where a higher score means more severe eczema, up to a maximum of 72), and how many participants were rated by a clinician as having "clear" or "almost clear" skin by the end of the 12 weeks. The reported data shows that at the 12-week mark, all four groups had lower EASI scores than when they started. The placebo group's score dropped by an average of 10.78 points, while the three tralokinumab dose groups dropped by 13.67, 15.14, and 15.72 points respectively. For the clinician skin-clearance rating, 11.8% of the placebo group reached the "clear or almost clear" level, compared with 11.6%, 19.5%, and 26.7% across the three tralokinumab dose groups. The reported data also shows that the number of participants who experienced adverse events (unexpected health changes during the study) was 31 in the placebo group and 36, 35, and 30 in the tralokinumab groups. Serious adverse events were recorded for 1 person in the placebo group, 3 in the first tralokinumab group, 2 in the second, and none in the third. Very few participants across any group had abnormal vital signs, lab results, or heart-tracing (ECG) results flagged as adverse events. 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 ↗
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NCT00654355 · results posted 6 June 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 children in total — 15 in a Control Group and 15 in an Extra Visit Group. The trial was looking at whether scheduling an additional clinic visit made a difference to how consistently children used their prescribed skin cream or ointment (called "topical therapy"). It also measured the severity of their eczema at the start and end of the study using two standard scoring tools used by doctors. The reported data shows that when it came to how often the required cream applications were actually completed, the Control Group completed an average of 56% of their required applications, while the Extra Visit Group completed an average of 72%. For one of the eczema severity measures — called the Investigator Global Assessment (IGA), where a score of 0 means clear skin and 4 means very severe disease — both groups showed the same reported change: a 33% reduction in their score from the start to week 4. For the second severity measure — called the EASI score, which runs from 0 to 72 with higher numbers meaning more severe eczema — the Control Group's average score at the end was reported as 2.1, while the Extra Visit Group's average score was reported as 1.0. It is worth noting that 2 participants in each group did not complete the study, and the reasons for this were 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.
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NCT00886587 · results posted 23 May 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 82 people with eczema — 41 in each group. One group used an investigational device (a skin treatment being tested), while the other used Atopiclair® Skin and Wound Emulsion, an existing product. Most participants finished the trial: 37 out of 41 in the investigational device group, and 39 out of 41 in the Atopiclair® group. The trial was primarily measuring changes in eczema severity and coverage using a scoring system called the EASI (Eczema Area and Severity Index), which runs from 0 (no eczema) to 72 (most severe), as well as secondary measures including an investigator's overall rating of eczema and a self-reported itch score. The reported data shows that by day 43, the EASI score had changed by an average of −4.97 points in the investigational device group and −5.01 points in the Atopiclair® group — where a negative number means the score went down (i.e. moved toward less severe) from where it started. An earlier check at day 15 showed changes of −3.79 and −4.14 respectively. The reported data also shows that the investigator's overall eczema rating (on a 0–5 scale from "clear" to "very severe") changed by 0.78 points in the investigational device group and 0.73 points in the Atopiclair® group — though the direction of this change (whether higher or lower is better) was not made explicit in the submitted data. For itch, participants rated their itch on a 0–10 scale, and the reported change by day 43 was −3.26 in the investigational device group and −3.29 in the Atopiclair® group, meaning itch scores went down from baseline 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.
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NCT01093469 · results posted 18 May 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 39 participants in total, divided equally into three groups of 13. Each group used a different moisturising skin product — Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream, or EpiCream Skin Barrier Emulsion. The trial was measuring how much each product improved a skin condition, as judged by a clinician using a standardised 7-point rating scale (ranging from 0, meaning "completely clear", up to 6, meaning "worse than at the start"). Almost all participants finished the study — one person in the EpiCream group did not complete it, and no reason for this was provided in the reported data. The reported data shows that all three groups received the same average score of 2 on the clinician's rating scale at the end of the study. A score of 2 on this scale was described as "marked improvement," meaning roughly a 75% improvement in the appearance of the skin condition as assessed by the clinician. No other outcome measure results were included in the data reported to ClinicalTrials.gov, so no further figures are 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02404493 · results posted 24 March 2017
According to the results reported on ClinicalTrials.gov, this trial compared two moisturising products — a 1% Colloidal Oatmeal Balm and EpiCream Skin Barrier Emulsion — in people with skin conditions. A total of 23 participants started the trial (17 in the oatmeal balm group and 6 in the EpiCream group), and 21 completed it (16 and 5 respectively). The trial used a device called a corneometer to measure moisture levels on the skin's surface at several points in time — immediately after applying the product, then at 12 hours, 24 hours, 3 days, 7 days, and 14 days after treatment. Higher corneometer readings indicate more moisture detected at the skin surface. The reported data shows the following changes in skin moisture readings compared to the starting point (baseline). Immediately after treatment, the oatmeal balm group showed a change of 656.31 units, while the EpiCream group showed a change of 234.72 units. At 12 hours after treatment, the reported changes were 55.12 units and 2.11 units respectively. At 24 hours, the figures were 178.35 units (oatmeal balm) and 14.83 units (EpiCream). At 3 days, the reported changes were 226.85 units and 8.17 units. At 7 days, 208.52 units and 17.50 units were reported. At 14 days, the reported changes were 158.65 units and 23.60 units. These figures represent changes from each group's own starting measurement, not a direct comparison between the two groups. It is worth noting that the two groups started with quite different numbers of participants (17 versus 6), which the reported data does not account for in these figures. No information about side effects or other outcomes was included in the structured results data submitted to ClinicalTrials.gov for this 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.
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NCT01301508 · results posted 7 March 2017
According to the results reported on ClinicalTrials.gov, this trial involved 46 people in total — 21 in one group and 25 in another. It was a study comparing two ointments for atopic dermatitis (a type of eczema): one called AN2898 at 1% strength, and one called AN2728 at 2% strength. In a design like this, each participant had two affected skin patches treated — one with the active ointment and one with a plain "vehicle" ointment (an ointment with no active ingredient, used as a comparison). The main thing being measured was a skin severity score called the ADSI, which rates five signs of eczema — redness, itching, weeping, scratching marks, and skin thickening — on a scale from 0 (no signs) to 15 (most severe). By the end of the study, 20 people in the AN2898 group and 22 in the AN2728 group had completed all visits. The reported data shows that at the start of the trial (Day 1), both groups had average ADSI scores of around 8 out of 15 for both their active-ointment and vehicle-ointment patches, indicating similarly scored skin at the beginning. Over time, the scores reported for both the active and vehicle patches went down in both groups. By Day 28 — the main measurement point — the AN2898 group's active patch had an average score of 2.6, compared to 4.3 for their vehicle patch. In the AN2728 group, the active patch averaged 2.8 and the vehicle patch averaged 5.1. Also at Day 28, the reported data shows that 71.4% of participants in the AN2898 group and 68.0% in the AN2728 group had a greater score reduction on their active-ointment patch compared to their vehicle patch. By contrast, 14.3% (AN2898 group) and 20.0% (AN2728 group) showed a greater reduction on the vehicle patch side. At Day 14 and Day 42, similar patterns in the percentage comparisons were reported — for example, at Day 14, 57.1% and 64.0% of participants respectively showed a bigger reduction on the active-ointment side, while at Day 42 those figures were 47.6% and 64.0%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02118766 · results posted 6 March 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02118766) enrolled 763 participants in total — 507 in the group that used AN2728 2% topical ointment (a medicated skin ointment) and 256 in the group that used a vehicle ointment (a matching ointment without the active ingredient, sometimes called a placebo). The trial was measuring outcomes in people with atopic dermatitis (eczema), looking at how their skin was rated by a clinician on a five-point scale, as well as tracking any medical events, changes in vital signs (such as blood pressure), and changes in blood test results over 29 days. The reported data shows that, at Day 29, about 32.8% of participants in the AN2728 group and 25.4% of participants in the vehicle group met the trial's main definition of "treatment success" — meaning their skin was rated as clear or almost clear AND had improved by at least two steps on the five-point scale from where it started. A secondary measure simply asked what share of participants had a clear or almost clear skin rating at Day 29, regardless of how much it had changed: the reported figures were 51.7% in the AN2728 group and 40.6% in the vehicle group. For the time it took participants to first reach treatment success, the data was recorded as "not available" — meaning those figures were not reported in the submitted results. Regarding the "time to treatment success" outcome, the data was not reported. The reported data also shows that 147 participants in the AN2728 group and 50 in the vehicle group experienced treatment-emergent adverse events (unexpected medical occurrences that happened during or after starting the study treatment). Serious adverse events — a more severe category involving hospitalisation, life-threatening situations, or other significant outcomes — were recorded for 5 participants in the AN2728 group and 1 in the vehicle group. No participants in either group were found to have clinically significant changes in their vital signs or blood test results at Day 29, according to investigator assessments. 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 ↗
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NCT01602341 · results posted 6 March 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 86 adults in total — 44 in a once-daily treatment group and 42 in a twice-daily treatment group. Each participant applied AN2728 ointment to two separate patches of skin affected by atopic dermatitis (eczema): one patch received the 0.5% strength and the other received the 2% strength. The trial used a scoring system called the Atopic Dermatitis Severity Index (ADSI) to track changes in skin condition. This score runs from 0 (no signs) to 15 (most severe), based on five features of eczema — redness, itching, weeping, scratching marks, and skin thickening. The primary goal was to measure how much the ADSI score changed from the start of the trial over four weeks. The reported data shows that all four treatment combinations started with very similar average ADSI scores at the beginning of the trial, ranging from about 8.0 to 8.2 out of 15. By Day 8, the reported average improvement (that is, the drop in score from the starting point) ranged from 2.80 points for the once-daily 0.5% group up to 4.81 points for the twice-daily 2% group. By Day 15, improvements ranged from 4.02 to 5.36 points; by Day 22, from 3.86 to 5.49 points; and by Day 29 (the final check), from 4.47 to 5.81 points. In all time points, the twice-daily 2% group showed the largest reported score reduction, while the once-daily 0.5% group showed the smallest. The reported data also includes two secondary measures relating to participants' general health checks. For clinically significant changes in vital signs (such as blood pressure and pulse), zero participants in either group were reported to have notable changes. For clinically significant abnormalities in blood or urine laboratory tests, one participant in the once-daily group was reported to have a notable finding, while none were reported in the twice-daily 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.
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NCT01366846 · results posted 6 January 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01366846) enrolled 556 children across four groups. Children were divided based on the result of a skin prick test (a small scratch on the skin to check for a reaction to peanut) done early in life — those with a negative result formed two groups (235 avoided peanuts, 228 consumed then avoided peanuts), and those with a positive result formed two other groups (47 avoided peanuts, 46 consumed then avoided peanuts). The trial was measuring how many children in each group went on to have a peanut allergy by the time they were 72 months (6 years) old, assessed by giving them a measured amount of peanut protein and observing whether they reacted. The reported data shows that, at 72 months of age, 52 out of the children in the group that continuously avoided peanuts were recorded as having a peanut allergy, compared with 13 out of the children in the group that consumed peanuts for a period before switching to avoidance. When broken down by skin prick test result, among children who had a negative skin prick test, 34 in the avoidance group were recorded as having a peanut allergy versus 7 in the consumption-then-avoidance group. Among children who had a positive skin prick test, 18 in the avoidance group were recorded as having a peanut allergy versus 6 in the consumption-then-avoidance group. A secondary measurement also looked at the consumption-then-avoidance group at 60 months of age, where 10 children in that group were recorded as having a peanut allergy, rising to 13 at 72 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00329784 · results posted 28 December 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 640 children in total, split into four groups based on two factors: whether they had shown a reaction to a peanut skin-prick test at the start of the study (called the "positive stratum" or "negative stratum"), and whether they were assigned to avoid peanuts or to regularly consume peanuts during the study period. The trial was designed to measure whether children who ate peanuts regularly from infancy developed peanut allergy by the time they were 5 years old (60 months), compared with children who avoided peanuts over the same period. A number of other conditions — including eczema, asthma, and rhinitis (hay fever-like symptoms) — were also measured at 60 months. The reported data shows that, when both groups of children (those who had and had not reacted to the skin-prick test at the start) were looked at together, 54 out of the peanut avoidance group were recorded as having a peanut allergy at 60 months, compared with 10 out of the peanut consumption group. Looking at each starting group separately, among children who had not reacted to the skin-prick test at the start, 36 in the avoidance group and 5 in the consumption group were recorded as having a peanut allergy at 60 months; among children who had reacted to the skin-prick test at the start, 18 in the avoidance group and 5 in the consumption group were recorded as having a peanut allergy at 60 months. The reported data also shows results for the other conditions measured. For eczema (scored on a 0–103 scale, where higher means more severe), the avoidance group had an average score of 7.6 and the consumption group had an average score of 6.6 at 60 months — both in the range the scale describes as mild. For asthma at 60 months, 50 children in the avoidance group and 54 in the consumption group were recorded as having asthma. For rhinitis, the numbers across the two types measured were broadly similar between groups. For skin-prick test reactions to other food allergens, the reported figures varied across the different allergens tested. 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 ↗
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NCT01992172 · results posted 25 March 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01992172) looked at a product called Photocil in people with atopic dermatitis (a skin condition commonly known as eczema). The trial was designed to compare Photocil against a placebo (an inactive comparison product — in this case, a low-strength SPF 2 sunscreen). The primary thing being measured was the number of times participants experienced pruritus (itching) in the last 30 days. According to the reported data, seven people were enrolled in the Photocil group and completed the study. Notably, no participants were recorded as starting or completing the placebo group, meaning the comparison arm appears to have had zero participants enrolled. The reported data shows that for the Photocil group, two measurements were recorded for the number of itching events in the last 30 days: 7.4 events and 1.9 events. These appear to represent measurements taken at different points in time (for example, before and after using the product), though the data as submitted does not clearly label which figure belongs to which time point. No outcome data was reported for the placebo group, which is consistent with no participants having been enrolled in that arm. Because only one group had participants, no direct comparison between Photocil and the placebo can be drawn from the reported figures. It is also worth noting that with only seven participants in a single group and no placebo comparison data available, the scope of what can be understood from these numbers is very limited. The data was not reported in a way that allows for any broader conclusions to be drawn. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01577628 · results posted 24 February 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01577628) was designed to study whether a moisturising cream called Lipikar Balm AP, applied to newborn babies, might be linked to differences in the proportion of children who went on to develop eczema (atopic dermatitis), asthma, or food allergies by the age of two. The trial also planned to look at whether a variation in a gene called filaggrin — which plays a role in skin barrier function — influenced any of those outcomes. Two groups of infants were to be compared: one group using the cream and one group receiving no intervention. The reported data shows that the trial did not enrol participants into either of the two intervention groups (the Lipikar Balm AP group or the no-intervention control group). Only two participants appear in the data, and both are listed under a "Screen Only" category, meaning they were screened for eligibility but not assigned to a study group. Both of those participants did not complete the study. No participants were recorded as having started or finished the main trial arms. Because no participants were enrolled into the treatment or control groups, the reported data shows no results for any of the outcome measures — neither the primary outcome (eczema development) nor any of the secondary outcomes (asthma, food allergy, or the filaggrin gene analyses). The figures for all outcomes were not reported, as the trial appears not to have proceeded beyond the screening stage. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01126268 · results posted 17 February 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 38 people who used a retapamulin 1% ointment to treat infected wounds. Of those, 37 completed the study and 1 did not. The trial was looking at whether the ointment could clear wound infections — in particular infections caused by a type of bacteria called MRSA (a germ that is resistant to many common antibiotics). Researchers checked for signs of infection such as redness, swelling, pain, crusting, and discharge, and assessed how participants responded at a follow-up visit after treatment. The reported data shows that, among the participants whose wound cultures tested positive for MRSA at the start, 5 out of that subgroup were considered a "clinical success" at follow-up (meaning no remaining signs or symptoms of infection). Looking at all participants, the trial also tracked three types of response at follow-up. For **clinical response**, 23 participants were rated a full clinical success, 11 showed clinical improvement, 0 showed no change, and 1 was rated a clinical failure. For **microbiological response** (whether the bacteria were cleared), 1 participant had confirmed eradication of the germ, 23 had presumed eradication, 10 had presumed improvement, and 1 had persistent bacteria. For the combined **therapeutic success** measure — requiring both a clinical success and a microbiological success — 23 participants met that definition. The reported data also shows how one specific sign of infection, redness (erythema), changed over the course of the trial. At the start, 0 participants had no redness, 10 had minimal redness, and 25 had moderate redness. At the follow-up visit, those numbers had shifted: 9 participants had no redness, 24 had minimal redness, and 2 had moderate redness, with none rated as severe at either 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 ↗
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NCT01785602 · results posted 15 December 2015
According to the results reported on ClinicalTrials.gov, this trial looked at a medication called QAW039 compared to a placebo (a dummy treatment with no active ingredient) in people with eczema (also called atopic dermatitis). A total of 76 people were assigned to receive QAW039 and 27 people received the placebo. Of those, 63 people in the QAW039 group and 18 in the placebo group completed the study. The trial's main focus was measuring changes in eczema severity using a scoring system called the Eczema Area and Severity Index (EASI), which rates how much of the skin is affected and how severe the signs are, on a scale from 0 (no disease) to 72 (most severe). The reported data shows that, for the primary outcome — the change in EASI score from the start of the trial — the QAW039 group had an average change of −8.65 points, while the placebo group had an average change of −6.95 points. On this scale, a negative number means the score went down from where it started (i.e., lower severity at the end compared to the beginning). For the secondary outcomes, which also measured EASI score changes at different time points during the study, the reported data shows figures of −6.22 (QAW039) versus −5.89 (placebo), and −7.49 (QAW039) versus −5.61 (placebo). No further breakdown of these time points 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT02001181 · results posted 15 October 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT02001181) enrolled 69 adults in total — 35 in the tofacitinib 20 mg/g cream (twice daily) group and 34 in the vehicle (an inactive comparison cream, also twice daily) group. The trial ran for 4 weeks and was measuring changes in the severity of atopic dermatitis (eczema) using several scoring tools, including a detailed skin assessment called the EASI (Eczema Area and Severity Index), a doctor's overall rating called the PGA (Physician's Global Assessment), and the proportion of body surface area affected. The reported data shows that, for the primary measure — the percentage change in EASI score from the start of the trial to week 4 — the tofacitinib group showed an average reduction of 81.7%, while the vehicle group showed an average reduction of 29.9%. For the secondary measures, the reported data shows that 71.4% of participants in the tofacitinib group and 20.6% in the vehicle group were rated by their doctor as "clear" or "almost clear" at week 4. When a stricter version of that rating was applied (also requiring at least a 2-point improvement from the start), 65.7% of the tofacitinib group and 11.8% of the vehicle group met that threshold. The reported data also shows the average body surface area affected fell by 72.7% in the tofacitinib group and 30.2% in the vehicle group. On a separate skin signs severity score (ranging from 0 to 48, where higher means more severe), the tofacitinib group had an average decrease of 11.4 points compared to a decrease of 4.1 points in the vehicle 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 ↗
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NCT02002871 · results posted 20 July 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 21 participants, with 20 completing the study and 1 not completing it. The trial compared blue light treatment applied to one area of skin against an untreated control area on the same person — meaning each participant acted as their own comparison. The main thing being measured was a change in eczema severity score, where a trained investigator rated five visible skin signs (redness, swelling, scratching marks, skin thickening, and crusting) on a scale from 0 (none) to 15 (worst). The trial also tracked redness using a skin-measuring device, and participants rated their own itch on a scale from 1 (no itch) to 100 (worst imaginable). The reported data shows that for the primary outcome — the change in eczema severity score from the start to the end of the treatment period — the blue light area showed an average improvement of 1.9 points on the 0–15 scale, while the control area showed an average improvement of 1.3 points. At a follow-up check after treatment ended, the reported data shows both the blue light and control areas had changed by the same amount (0.5 points) from their end-of-treatment scores. For the device-measured redness, the numbers reported varied across time points and included both increases and decreases in both groups. For self-rated itch, the reported data shows changes in both the blue light and control areas at different time points, with the control area showing larger reductions in itch at some points and the blue light area showing a larger reduction at the follow-up period. It is worth noting that because each participant's own untreated skin area served as the comparison, some differences between measurements may reflect natural variation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00946478 · results posted 10 March 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 40 adults with atopic dermatitis (a type of eczema). The study was divided into two groups of 20 people each — one group used a cream containing pimecrolimus (an active ingredient) and the other used a plain vehicle cream (a cream with no active ingredient, sometimes called a placebo). All 40 participants completed the trial. The trial was measuring the levels of a specific substance in the skin called cathelicidin — a protein involved in the body's natural defences — by analysing small skin samples (biopsies) taken before and after three weeks of treatment. The reported data shows that cathelicidin activity was measured using a laboratory technique that produces values in units called "delta-delta CT units." Lower numbers in this type of measurement generally indicate lower detected levels of the substance being looked at. The pimecrolimus group returned a reported value of 0.0016, while the vehicle cream group returned a reported value of 0.0024. These are the only outcome figures reported in the submitted data; no additional secondary outcome measures were 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.
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NCT00346398 · results posted 16 December 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 51 children in total — 25 in the group receiving a treatment called OMIP (given alongside timothy grass, cat, and house dust mite allergens) and 26 in the placebo group. The trial was measuring whether, three years after treatment ended, children had developed allergic sensitisation (signs that the immune system had become reactive to allergens, detected by a blood test or a skin prick test) and whether they had developed asthma. The reported data shows that, at the three-year follow-up point, 22 out of 22 children who completed the OMIP treatment group tested positive for allergic sensitisation, compared with 19 out of 24 children in the placebo group. For asthma, the reported data shows 4 children in each group met the definition of current asthma at that same point. The trial also recorded the time until a first asthma diagnosis was made: the reported average was 31.0 months for the OMIP group and 38.3 months for the placebo group. It is worth noting that these are small numbers of participants, so the figures should be read with that in mind. 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 ↗
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NCT00723489 · results posted 30 September 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 82 people in total across four groups. Participants received a yellow fever vaccine (called YFV-17D) given either by a standard under-the-skin injection (SC) or via a tiny needleless skin patch device (TC). Within each delivery method, some participants had a condition called atopic dermatitis — a type of chronic skin condition — (AD groups) and some did not (Non-AD groups). The trial was primarily measuring how well each person's immune system responded to the vaccine by looking at antibody levels in the blood — antibodies being proteins the body makes to fight a specific germ. The reported data shows that the main measurement used was something called the Log10 Neutralisation Index (LNI), which reflects how much the body's virus-fighting ability changed after vaccination — a score of 0.7 or above is described in the data as suggesting an immune response was present. For both the patch (TC) and injection (SC) groups, the reported average LNI scores were 1.8 across all four groups, sitting above that 0.7 threshold. A second antibody measurement (NT50, which looks at how concentrated the antibodies were) showed reported scores ranging from 3.5 to 3.8 across the groups, with higher numbers indicating more antibody present. The reported data also shows how many individuals in each group reached that 0.7 LNI threshold (called "seroconversion" — meaning their blood showed a measurable immune response). For the patch (TC) groups, 18 out of the atopic dermatitis participants and 14 out of the non-atopic dermatitis participants reached this level, while 2 and 5 respectively did not. For the injection (SC) groups, 14 atopic dermatitis participants and 20 non-atopic dermatitis participants reached the threshold, while 1 and 0 respectively did not. 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 ↗
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NCT00455429 · results posted 1 July 2013
According to the results reported on ClinicalTrials.gov, this trial looked at a experimental drug called JNJ-26113100 in people with atopic dermatitis (eczema). A total of 84 people were enrolled across four groups: 18 received a placebo (a dummy treatment with no active ingredient), 15 received 50 mg of JNJ-26113100 once daily, 17 received 100 mg once daily, and 34 received 100 mg twice daily. The trial ran for 6 weeks and measured things like overall skin appearance, the area and severity of eczema across the body, and how much itching participants experienced. The reported data shows a range of results across the groups at the 6-week mark. For overall skin appearance (rated on a 0–5 scale where lower is better), the average scores at the start were similar across all groups. For the eczema severity score (which runs from 0 to 72, with higher meaning worse), the reported change from the start was: placebo group minus 2.3 points, 50 mg once-daily group minus 5.5 points, 100 mg once-daily group minus 3.7 points, and 100 mg twice-daily group minus 4.2 points. For itch (measured on a 0–100 scale), the reported change from the start was: placebo minus 24.8 points, 50 mg once-daily minus 19.9 points, 100 mg once-daily minus 22.8 points, and 100 mg twice-daily minus 20.6 points. The reported data also shows what percentage of participants in each group reached certain targets by week 6. For the skin appearance score reaching "clear" or "almost clear": placebo 27.8%, 50 mg once-daily 40.0%, 100 mg once-daily 17.6%, and 100 mg twice-daily 18.8%. For achieving at least a 50% reduction in the eczema severity score: placebo 44.4%, 50 mg once-daily 60.0%, 100 mg once-daily 41.2%, and 100 mg twice-daily 31.3%. It is worth noting that not all participants who started the trial completed it — particularly in the 100 mg twice-daily group, where 14 out of 34 did not finish. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01132651 · results posted 16 January 2013
According to the results reported on ClinicalTrials.gov, this trial looked at whether a cooling pillow (called a "Chillow") compared to a regular pillow affected sleep quality and skin condition in people with atopic dermatitis (a type of eczema). A total of 9 people started the trial — 4 in the cooling pillow group and 5 in the regular pillow group. Of those, 7 people completed the study (3 in the cooling pillow group and 4 in the regular pillow group), with one person from each group not finishing. The reported data shows that sleep quality was measured using a standardised questionnaire called the Pittsburgh Sleep Quality Index (PSQI), where lower scores indicate better sleep quality and higher scores indicate worse sleep quality, on a scale of 0 to 21. The results reported a change (improvement) of minus 1 point for the cooling pillow group and minus 2 points for the regular pillow group — meaning both groups showed a small reduction in their score over the course of the study. For the secondary measure, skin condition severity was assessed using a scale of 0 to 5 (where 0 means no signs of the condition and 5 means severe). The reported data shows both the cooling pillow group and the regular pillow group each had a change of minus 1 point in their skin condition score. It is worth noting that this was a very small study with fewer than 10 participants, and no further details about the statistical meaning of these numbers were reported in the submitted data. Any broader conclusions about what these numbers might mean would go beyond what was 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.
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NCT00903357 · results posted 13 September 2012
According to the results reported on ClinicalTrials.gov, this trial involved 54 participants in total (27 in each group) and used a "crossover" design — meaning each person received both the active medicine (montelukast sodium, a tablet) and a dummy pill (placebo) at different times, with a two-week break in between. By the end of the trial, 43 participants completed both treatment periods. The trial was measuring three things: a skin condition score called the SCORAD index (which combines the area of skin affected, how severe the skin looks, and how the person feels — scored from 0 to 103, with higher numbers meaning worse symptoms), and two substances measured in urine — LTE4 and EDN — which are markers associated with certain immune responses in the body. The reported data shows the following changes from the start of each treatment period. For the SCORAD skin score, participants on montelukast had an average change of −3.0 points (a small decrease), while those on the placebo had an average change of −5.7 points (also a decrease). For urinary LTE4, the montelukast group showed an average change of −65.9 pg/ml (a decrease), while the placebo group showed an average change of +87.7 pg/ml (an increase). For urinary EDN, the montelukast group showed an average change of +37.0 ng/ml (an increase), while the placebo group showed an average change of −195.8 ng/ml (a decrease). These are the numbers as submitted; no further breakdown or explanation of these figures was provided 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.
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NCT00929981 · results posted 26 December 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 80 participants, all of whom completed the study with no drop-outs. All participants received Medrol (a corticosteroid medication). The trial was measuring how well the treatment controlled contact dermatitis — a type of skin reaction — at several check-up visits over time. A doctor rated each participant's skin using a five-point scale (from 0 meaning no reaction to 4 meaning a severe, spreading reaction), and a score of 0 or 1 was counted as a "success" while a score of 2 or higher was counted as a "failure." Participants also rated their own skin and itch severity on a scale of 0 to 10. The reported data shows that at the first follow-up visit, 52.5% of participants were rated a "success" and 47.5% a "failure." By the second follow-up, the reported success rate had risen to 93.8%, with 6.3% still rated as "failure." At both the third and final follow-up visits, 100% of participants were rated as "success" and 0% as "failure." For the participant-rated scores, the reported data shows that at the start of the study the average severity score was 6.8 out of 10 and the average itch score was 7.3 out of 10. By the final follow-up, participants reported changes of approximately −6.8 points in severity and −7.2 points in itch, meaning their self-reported scores had dropped close to zero on both 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.
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NCT00931411 · results posted 3 February 2011
According to the results reported on ClinicalTrials.gov, this trial involved 73 children with atopic dermatitis (a skin condition commonly known as eczema). It used a "crossover" design, meaning participants tried both of two different cream formulations — called Formulation 609580 20 and Formulation 609209 — at different points during the study. The trial measured changes in eczema severity, overall improvement as rated by the investigating clinician and by parents, quality of life, and how acceptable the creams felt to use. The reported data shows that eczema severity was tracked using a scoring tool called SCORAD, which combines skin appearance, the percentage of the body affected, itch, and sleep disruption into a single number (0 = no symptoms, 103 = worst possible). After 7 days, the SCORAD score had dropped by about 35.5% for Formulation 609580 20 and about 49.7% for Formulation 609209. By day 42, those figures were approximately 56.6% and 62.0% respectively. For the clinician-rated improvement scale (0 = worsening, 5 = excellent improvement), both formulations scored around 3.2–3.5 at day 7 and 3.9–4.1 at day 42. Parent-rated improvement scores followed a similar pattern. Quality of life scores (on a scale where higher means better) were reported as 23.74 for Formulation 609580 20 and 23.09 for Formulation 609209 at day 42. Cosmetic acceptability scores (where more negative means better on the scale used) were in a similar range for both formulations before and after the crossover 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.
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NCT00160563 · results posted 4 August 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 207 people across three groups. The first group (59 people) received a treatment called LCTZ throughout the study. The second group (47 people) received LCTZ for one part of the study and then switched to a placebo (a dummy treatment with no active ingredient). The third group (101 people) received a placebo for the entire study. The trial was measuring how long it took for participants to develop asthma, with the aim of understanding whether the timing of asthma onset differed between the groups. The reported data shows that a large proportion of participants did not complete the study — only 8 people in the first group, 2 in the second group, and 11 in the third group finished. The remaining participants (51, 45, and 90 respectively) did not complete the study, though the reasons for this are not detailed in the submitted data. There was also a secondary measure looking at time to asthma onset specifically in people who had remained asthma-free after the first 18 months of the trial. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for either the primary outcome (time to onset of asthma) or the secondary outcome (time to onset of asthma in those still asthma-free after 18 months). The actual measurements for both of these outcomes were not reported in the data available, so it is not possible to describe what the numbers showed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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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.