NCT07916480Not yet recruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
A Phase 3, 52-Week Study of Once-Daily Roflumilast Cream 0.3% in Participants With Moderate to Severe Atopic Dermatitis, Including a 4-Week Double-Blind, Vehicle-Controlled Phase Followed by a 48-Week Open-Label Extension
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
This Phase 3 study is designed to evaluate the efficacy and safety of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis. Approximately 415 participants will be randomized in a 2:1 ratio to receive roflumilast cream 0.3% or matching vehicle cream during a 4-week double-blind, vehicle-controlled treatment period. Following completion of the double-blind treatment period, all participants will enter a 48-week open-label extension and receive roflumilast cream 0.3%. The study will assess the efficacy of roflumilast cream 0.3% in improving signs and symptoms of atopic dermatitis and evaluate its long-term safety and tolerability through Week 52.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 415 (estimated)
- First submitted
- 30 Oct 2026
- Start date
- 20 Oct 2026
- Primary completion date
- 27 Apr 2028
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07916480
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 415
- From 20 Oct 2026 to the primary completion date, 27 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of prohibited medications within protocol-defined washout periods.
Other illness
- Uncontrolled medical conditions that could interfere with study participation.
- Skin disorders that may confound study assessments.
- Active infection requiring systemic treatment.
- Known hypersensitivity to roflumilast or formulation components.
- Any condition that, in the investigator's opinion, would make participation unsafe or interfere with study results.
Other
- Pregnant or breastfeeding participants.
- Participation in another interventional clinical trial within the protocol-defined timeframe.
Who the study is looking for
- Male or female participants aged 6 years and older.
- Clinical diagnosis of moderate to severe atopic dermatitis.
- vIGA-AD score of 3 (Moderate) or 4 (Severe) at baseline.
- EASI score ≥5 at baseline.
- Atopic dermatitis involvement of ≥3% and ≤30% body surface area.
- Able and willing to comply with study procedures.
- Participant or parent/legal guardian able to provide informed consent/assent.
Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.