At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 652 enrolled
Drug / intervention
Roflumilast Cream 0.05% +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 0.05% Administered QD in Subjects With Atopic Dermatitis
In Brief
A Phase 3 clinical trial evaluating Roflumilast Cream 0.05% and Vehicle Cream for Atopic Dermatitis Eczema. Completed, enrolled 652 participants across 76 sites in 2 countries.
Detailed Summary
This was a Phase 3, 4-week, double-blind study to assess the safety and efficacy of ARQ-151 cream compared to vehicle cream applied once daily (qd) for 4 weeks in children 2 to 5 years of age with atopic dermatitis (AD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis Eczema
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
Enrollment StartApr 2021
First PostedApr 2021
Primary CompletionJun 2023
TodayJul 2026
First PostedApr 15, 2021
Enrollment StartApr 7, 2021
Primary CompletionJun 1, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.2 years ago
Interventions
Roflumilast Cream 0.05%drug
Roflumilast cream for topical application.
Vehicle Creamdrug
Vehicle cream matched to roflumilast cream for topical application.