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Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

NCT04845620 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 652

Last updated 2025-12-23

Study results available
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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).

Conditions

  • Atopic Dermatitis Eczema

Interventions

DRUG

Roflumilast Cream 0.05%

Roflumilast cream for topical application.

DRUG

Vehicle Cream

Vehicle cream matched to roflumilast cream for topical application.

Sponsors & Collaborators

  • Arcutis Biotherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • David Berk, MD · Arcutis Biotherapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2023-06-01
Completion
2023-06-01
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 NCT04845620 on ClinicalTrials.gov