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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

Who can join

Ages 6 and older · All sexes

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.

About the study

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.

What is being tested

• Roflumilast Cream 0.3% (drug)
• Vehicle Cream (drug)

Sponsor: Arcutis Biotherapeutics, Inc. · Participants: 415 · Started: Oct 30, 2026

Contact the study team

• Arcutis Medical Information · Phone: 1-844-692-6729

Official record on ClinicalTrials.gov — NCT07916480

Locations in the U.S.

Conditions

• Atopic Dermatitis (Eczema)
• Eczema
• Itching
• Dermatitis

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.