Trials / Completed
CompletedNCT04973228
Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)
A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 457 (actual)
- Sponsor
- Arcutis Biotherapeutics, Inc. · Industry
- Sex
- All
- Age
- 9 Years
- Healthy volunteers
- Not accepted
Summary
This phase 3, double-blind, vehicle-controlled study assessed the safety and efficacy of roflumilast (ARQ-154) foam 0.3% applied once daily (qd) for 8 weeks by participants with seborrheic dermatitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Roflumilast Foam | Roflumilast 0.3% foam for topical application |
| DRUG | Vehicle Foam | Vehicle foam for topical application |
Timeline
- Start date
- 2021-07-08
- Primary completion
- 2022-04-06
- Completion
- 2022-04-06
- First posted
- 2021-07-22
- Last updated
- 2024-03-12
- Results posted
- 2024-03-12
Locations
53 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04973228. Inclusion in this directory is not an endorsement.