CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 457 enrolled
Drug / intervention
Roflumilast Foam +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.

Search/NCT04973228
NCT04973228Phase 3Completed
CompareCT.gov

A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis

Arcutis Biotherapeutics, Inc.·interventional·Posted Jul 22, 2021·Updated Mar 12, 2024

In Brief

A Phase 3 clinical trial evaluating Roflumilast Foam and Vehicle Foam for Seborrheic Dermatitis. Completed, enrolled 457 participants across 53 sites in 2 countries.

Detailed Summary

This phase 3, double-blind, vehicle-controlled study assessed the safety and efficacy of roflumilast (ARQ-154) foam 0.3% applied once daily (qd) for 8 weeks by participants with seborrheic dermatitis.

Study Details

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

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJul 22, 2021
Enrollment StartJul 8, 2021
Primary CompletionApr 6, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.9 years ago

Interventions

Roflumilast Foamdrug

Roflumilast 0.3% foam for topical application

Vehicle Foamdrug

Vehicle foam for topical application