CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,220 enrolled
Drug / intervention
ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04804605
NCT04804605Phase 3Completed
CompareCT.gov

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

Arcutis Biotherapeutics, Inc.·interventional·Posted Mar 18, 2021·Updated Dec 23, 2025

In Brief

A Phase 3 clinical trial evaluating ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% for Atopic Dermatitis Eczema. Completed, enrolled 1,220 participants across 92 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis Eczema
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedMar 18, 2021
Enrollment StartFeb 25, 2021
Primary CompletionMay 28, 2024
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.3 years ago

Interventions

ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%drug

ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%