This Phase 3 study is designed to measure the how well it works and safety of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis. Approximately 415 you would be randomly assigned in a 2:1 ratio to receive roflumilast cream 0.3% or matching vehicle cream during a 4-week neither you nor the study doctors know who gets the real treatment, vehicle-controlled treatment period.
Official registry: https://clinicaltrials.gov/study/NCT07916480 · Arcutis Biotherapeutics, Inc. · enrollment listed as 415
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Roflumilast Cream 0.3%, or Vehicle Cream. The registry lists allocation as randomized. This Phase 3 study is designed to measure the how well it works and safety of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis.
They plan to enroll about 415 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
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
Interventions: Roflumilast Cream 0.3%, Vehicle Cream
Primary outcome (registry wording): Achievement of vIGA-AD Success at Week 4
Arcutis Medical Information
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
This is a tissue, urine, and blood banking protocol for cutaneous t-cell lymphoma (CTCL), eczema, and atopic dermatitis patients for current and future research.
NCT00177268 · Official ClinicalTrials.gov record · University of Pittsburgh
This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema.
NCT00605878 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)
Background: \- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have infections with S.
NCT01631617 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary