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Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

NCT04804605 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1220

Last updated 2025-12-23

Study results available
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Summary

This study was a Phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% (completers of studies ARQ-151-311 or ARQ-151-312 aged ≥6 years and ARQ-151-315 rollovers who turned 6 years of age on study) or roflumilast cream 0.05% (ARQ-151-315 rollovers aged 2 to 5 years). Participants with mild to moderate atopic dermatitis (AD) applied roflumilast cream once daily (qd) for up to 52 weeks.

Conditions

  • Atopic Dermatitis Eczema

Interventions

DRUG

ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%

ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%

Sponsors & Collaborators

  • Arcutis Biotherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • David Berk, MD · Arcutis Biotherapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-25
Primary Completion
2024-05-28
Completion
2024-05-28
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04804605 on ClinicalTrials.gov