Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis

Summary

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%.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Atopic Dermatitis
• Atopic Dermatitis (AD)
• Atopic Dermatitis (Eczema)

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

6 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Arcutis Biotherapeutics, Inc.

Last updated on ClinicalTrials.gov

November 6, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites