NCT04804605

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

A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects With Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,220 (actual)
• Sponsor: Arcutis Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis Eczema

Interventions

Type	Name	Description
DRUG	ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%	ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%

Timeline

• Start date: 2021-02-25
• Primary completion: 2024-05-28
• Completion: 2024-05-28
• First posted: 2021-03-18
• Last updated: 2025-12-23
• Results posted: 2025-12-23

Locations

92 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study