Roflumilast Cream 0.3% for moderate to severe atopic dermatitis in children, adolescents, and adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, multicenter trial tests the efficacy and safety of once-daily roflumilast cream 0.3% versus vehicle in participants aged 6 years and older with moderate to severe atopic dermatitis. The study uses a 4-week double-blind, vehicle-controlled period followed by a 48-week open-label extension where all participants receive roflumilast cream, totaling 52 weeks of assessment. Primary efficacy is assessed at Week 4, with secondary efficacy measures covering additional signs and symptoms of eczema, and long-term safety and tolerability monitored through Week 52. Safety evaluations include adverse events, local tolerability, labs, vital signs, and physical exams. Approximately 415 participants are randomized in a 2:1 ratio to roflumilast cream or vehicle. Lead sponsor is Arcutis Biotherapeutics, with three sites located in Alabama, Arkansas, and Florida.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female participants aged 6 years and older.
2. Clinical diagnosis of moderate to severe atopic dermatitis.
3. vIGA-AD score of 3 (Moderate) or 4 (Severe) at baseline.
4. EASI score ≥5 at baseline.
5. Atopic dermatitis involvement of ≥3% and ≤30% body surface area.
6. Able and willing to comply with study procedures.
7. Participant or parent/legal guardian able to provide informed consent/assent.

Exclusion Criteria:

1. Uncontrolled medical conditions that could interfere with study participation.
2. Skin disorders that may confound study assessments.
3. Active infection requiring systemic treatment.
4. Known hypersensitivity to roflumilast or formulation components.
5. Use of prohibited medications within protocol-defined washout periods.
6. Pregnant or breastfeeding participants.
7. Participation in another interventional clinical trial within the protocol-defined timeframe.
8. Any condition that, in the investigator's opinion, would make participation unsafe or interfere with study results.

Where it's running

• Arcutis Site 324
  Birmingham, Alabama, United States Recruiting
• Arcutis Site 337
  Bryant, Arkansas, United States Recruiting
• Arcutis Site 321
  Miami Lakes, Florida, United States Recruiting
• Arcutis Site 320
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Arcutis Medical Information
• Email: medinfo@arcutis.com
• Phone: 1-844-692-6729

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.