drugset / Trial / NCT04804605
Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
NaSingle-groupOpen-labelTreatment
Summary
This study was a Phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% (completers of studies ARQ-151-311 or ARQ-151-312 aged ≥6 years and ARQ-151-315 rollovers who turned 6 years of age on study) or roflumilast cream 0.05% (ARQ-151-315 rollovers aged 2 to 5 years). Participants with mild to moderate atopic dermatitis (AD) applied roflumilast cream once daily (qd) for up to 52 weeks.
Timeline
- Start
- 2021-02-25
- Primary completion
- 2024-05-28
- Completion
- 2024-05-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Roflumilast | Small molecule | 0.05 % | Topical |
| Subject | Roflumilast | Small molecule | 0.15 % | Topical |