Roflumilast Cream for Eczema
(INTEGUMENT 3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for children, teens, and adults with moderate to severe atopic dermatitis (eczema). Participants should have noticeable symptoms of eczema. People with certain other skin conditions or health issues may not be able to join.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Roflumilast Cream 0.3%
Trial Overview
The study compares once-daily roflumilast cream 0.3% to a placebo cream for 4 weeks in people with eczema. After this period, everyone uses the active cream for up to 48 more weeks to check long-term effects and safety.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will apply roflumilast cream 0.3% once daily during the 4-week double-blind treatment period.
Participants will apply matching vehicle cream once daily during the 4-week double-blind treatment period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Arcutis Biotherapeutics, Inc.
Lead Sponsor
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