At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 683 enrolled
Drug / intervention
Roflumilast Cream +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 and Vehicle cream for Atopic Dermatitis Eczema. Completed, enrolled 683 participants across 53 sites in 2 countries.
Detailed Summary
This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema). This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 0.15% cream or vehicle is applied once daily (qd) for 4 weeks by participants with atopic dermatitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis Eczema
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
Enrollment StartFeb 2021
First PostedFeb 2021
Primary CompletionSep 2022
TodayJul 2026
First PostedFeb 26, 2021
Enrollment StartFeb 24, 2021
Primary CompletionSep 29, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.4 years ago
Interventions
Roflumilast Creamdrug
Roflumilast cream 0.15% for topical application
Vehicle creamdrug
Vehicle cream for topical application