Trials / Completed
CompletedNCT04773587
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects With Atopic Dermatitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 654 (actual)
- Sponsor
- Arcutis Biotherapeutics, Inc. · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
Summary
This is a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) cream vs vehicle applied once daily (qd) for 4 weeks by participants with atopic dermatitis (eczema).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Roflumilast Cream 0.15% | Roflumilast Cream 0.15% - Active |
| DRUG | Vehicle Cream | Cream - Vehicle |
Timeline
- Start date
- 2021-01-27
- Primary completion
- 2022-08-30
- Completion
- 2022-08-30
- First posted
- 2021-02-26
- Last updated
- 2024-10-09
- Results posted
- 2024-10-09
Locations
49 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04773587. Inclusion in this directory is not an endorsement.