At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 136 enrolled
Drug / intervention
Roflumilast Cream 0.05% +2 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 2, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% and ARQ-151 Cream 0.15% Administered QD (Quaque Die) in Adolescent and Adult Subjects With Atopic Dermatitis
In Brief
A Phase 2 clinical trial evaluating Roflumilast Cream 0.05%, Roflumilast Cream 0.15%, and 1 other intervention for Atopic Dermatitis. Completed, enrolled 136 participants across 20 sites in 2 countries.
Detailed Summary
The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days by adolescents and adults with atopic dermatitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartMay 2019
Primary CompletionNov 2019
TodayJul 2026
First PostedApr 16, 2019
Enrollment StartMay 31, 2019
Primary CompletionNov 4, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.2 years ago
Interventions
Roflumilast Cream 0.05%drug
Roflumilast 0.05% cream for topical application
Roflumilast Cream 0.15%drug
Roflumilast 0.15% cream for topical application
Vehicle Creamdrug
Inactive vehicle cream matched to roflumilast cream for topical application.