Trial 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
According to the results reported on ClinicalTrials.gov, this trial (NCT04128007) enrolled 304 people with plaque psoriasis affecting the scalp — 200 in the roflumilast foam 0.3% group and 104 in the vehicle foam (a foam containing no active ingredient, used for comparison) group. Of those, 177 and 87 participants respectively completed the study. The trial ran for 8 weeks and measured how participants' scalp psoriasis responded, using several standardised rating scales scored by both clinicians and the participants themselves. The reported data shows that, on the main measure — a clinician-rated scalp assessment called the S-IGA — 107 out of 200 participants in the roflumilast group reached the target score of "clear" or "almost clear" (with at least a 2-grade improvement from the start), compared with 10 out of 104 in the vehicle group. On a similar body-wide assessment at week 8, 73 roflumilast participants and 6 vehicle participants reached that same threshold. For scalp itch (rated by participants on a 0–10 scale), the numbers achieving a meaningful reduction of 4 or more points were reported as 74 vs 14 at week 2, 98 vs 19 at week 4, and 110 vs 15 at week 8. On a broader symptom diary (scored 0–160, where lower is better), average scores dropped by 45.0 points (roflumilast) vs 25.4 points (vehicle) at week 4, and by 55.0 vs 27.5 points at week 8. The reported data also shows that the roflumilast group reached a 50% reduction in a detailed scalp severity score in a median of 28 days; a comparable figure for the vehicle group was not reported. Finally, 121 roflumilast participants and 19 vehicle participants achieved a 75% reduction in that same scalp severity score. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Psoriasis Trial, Completed
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- You are able to read, write, and sign a consent form; if you are a teenager, a parent or guardian can provide consent on your behalf
- You are male or female and aged 12 years or older
- You have scalp psoriasis that has been rated at least "mild" by the investigating doctor at the start of the study
- Your scalp psoriasis scores at least 6 on a standard medical severity scale (PSSI) at the start of the study
- Your overall psoriasis scores at least 2 on another standard severity scale (PASI) at the start of the study
- You have been diagnosed with common plaque psoriasis for at least 6 months, and your condition has been stable for the past 4 weeks
- If you are a woman who could become pregnant, you must have a negative pregnancy test at both your screening visit and your baseline visit
- If you are a woman who cannot become pregnant, you must either have gone through menopause (with no periods for at least 12 months) or have had a surgical procedure to prevent pregnancy
- You are in generally good health as assessed by the doctor based on your medical history, physical checks, and lab tests
- You are considered able and willing to follow the study schedule and requirements
Who may not be able to join:
- You are unable to stop certain medications or treatments before and during the study as required by the study rules
- You plan to spend a lot of time in natural sunlight, tanning beds, or under artificial UV/LED light on the treated areas during the study
- You are currently taking lithium or antimalarial medicines
- You are planning to start or change medications that could affect your psoriasis, such as beta blockers or ACE inhibitors (confirm with trial site)
- You have been diagnosed with a non-plaque form of psoriasis, such as guttate, pustular, or a form affecting only the palms and soles, or your psoriasis was caused by a medication
- You have any other skin condition on the treatment area that could interfere with measuring how well the treatment works
- You have a known allergy to any ingredient in the study treatment (ARQ-154)
- You are unable to stop taking certain strong medications that affect how the body processes drugs (known as strong P-450 inhibitors, e.g., ritonavir, ketoconazole, clarithromycin) for at least two weeks before and during the study (confirm with trial site)
- You are unable to stop taking certain other medications that affect how the body processes drugs (known as strong P-450 inducers, e.g., rifampin, carbamazepine, phenobarbital) for at least two weeks before and during the study (confirm with trial site)
- You scored 10 or higher on a standard depression screening questionnaire (PHQ-8 or modified PHQ-A) at your screening or baseline visit
- You are pregnant, trying to become pregnant during the study, or are currently breastfeeding
- You have a serious medical condition or abnormal lab results that the doctor believes would make it unsafe for you to participate
- You have a history of alcohol or drug misuse within the past 6 months
- You have had major surgery in the 4 weeks before the start of the study, or you have major surgery planned during the study
- You are unable to communicate in or understand the local language, or the doctor considers you unsuitable for the study for another reason
- You currently have or have had cancer within the past 5 years, with the exception of certain treated skin cancers (basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ)
- You have had an active infection requiring antibiotic, antifungal, or antiviral medication within 7 days before the start of the study
- You are a family member of someone working at the study site or for the study sponsor, or you live in the same household as another person already enrolled in the study
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: David Berk, MD, Arcutis Biotherapeutics
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.