drugset / Trial / NCT04804605

Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

NCT04804605

Phase 3 Completed 1220 enrolled Arcutis Biotherapeutics, Inc.
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

EvaluationDrugModalityDoseRoute
Subject Roflumilast Small molecule 0.05 % Topical
Subject Roflumilast Small molecule 0.15 % Topical

Indications