Trials / Completed
CompletedNCT04845620
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)
A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects With Atopic Dermatitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 652 (actual)
- Sponsor
- Arcutis Biotherapeutics, Inc. · Industry
- Sex
- All
- Age
- 2 Years – 5 Years
- Healthy volunteers
- Not accepted
Summary
This was a Phase 3, 4-week, double-blind study to assess the safety and efficacy of ARQ-151 cream compared to vehicle cream applied once daily (qd) for 4 weeks in children 2 to 5 years of age with atopic dermatitis (AD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Roflumilast Cream 0.05% | Roflumilast cream for topical application. |
| DRUG | Vehicle Cream | Vehicle cream matched to roflumilast cream for topical application. |
Timeline
- Start date
- 2021-04-07
- Primary completion
- 2023-06-01
- Completion
- 2023-06-01
- First posted
- 2021-04-15
- Last updated
- 2025-12-23
- Results posted
- 2025-12-23
Locations
76 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04845620. Inclusion in this directory is not an endorsement.