Roflumilast cream for moderate to severe atopic dermatitis (eczema)
Tests roflumilast cream on the skin of people with moderate to severe atopic dermatitis.
Plain-language title generated from the registry record
Registry title: Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Key facts
- Where
- Birmingham, Bryant, Chicago, and Miami Lakes, United StatesSee the 4 sites
- Phase
- Phase 3
Where in United States
- BirminghamBirmingham, United StatesTaking people
- BryantBryant, United StatesTaking people
- ChicagoChicago, United StatesTaking people
- Miami LakesMiami Lakes, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Arcutis Biotherapeutics, Inc.
- Trial code
- NCT07916480
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Use of prohibited medications within protocol-defined washout periods; 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; Pregnant or breastfeeding participants; Participation in another interventional clinical trial within the protocol-defined timeframe.