CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 408 enrolled
Drug / intervention
ARQ-154drug
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/NCT04445987
NCT04445987Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, Open-Label Study of the Long-Term Safety of ARQ-154 Foam 0.3% in Subjects With Seborrheic Dermatitis

Arcutis Biotherapeutics, Inc.·interventional·Posted Jun 24, 2020·Updated Jun 11, 2024

In Brief

A Phase 2 clinical trial evaluating ARQ-154 for Seborrheic Dermatitis. Completed, enrolled 408 participants across 39 sites.

Detailed Summary

This is an open-label, long-term safety study of roflumilast ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA). Study was applied topically once daily for 52 weeks. Cohort 1 subjects are rollover subjects from study ARQ-154-203 (NCT04091646) and were rolled into treatment in the current study without interruption. Cohort 2 includes participants from ARQ-154-203 who began treatment in the current study after a gap from completing treatment in the prior study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeborrheic Dermatitis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJun 24, 2020
Enrollment StartJun 12, 2020
Primary CompletionNov 19, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.0 years ago

Interventions

ARQ-154drug

ARQ-154 foam 0.3% applied once daily for 52 weeks