At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 654 enrolled
Drug / intervention
Roflumilast Cream 0.15% +1 moredrug
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.
A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects With Atopic Dermatitis
In Brief
A Phase 3 clinical trial evaluating Roflumilast Cream 0.15% and Vehicle Cream for Atopic Dermatitis Eczema. Completed, enrolled 654 participants across 49 sites in 2 countries.
Detailed Summary
This is a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) cream vs vehicle applied once daily (qd) for 4 weeks by participants with atopic dermatitis (eczema).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis Eczema
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
Enrollment StartJan 2021
First PostedFeb 2021
Primary CompletionAug 2022
TodayJul 2026
First PostedFeb 26, 2021
Enrollment StartJan 27, 2021
Primary CompletionAug 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.4 years ago
Interventions
Roflumilast Cream 0.15%drug
Roflumilast Cream 0.15% - Active
Vehicle Creamdrug
Cream - Vehicle