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Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

NCT04773587 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 654

Last updated 2024-10-09

Study results available
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Summary

This is a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) cream vs vehicle applied once daily (qd) for 4 weeks by participants with atopic dermatitis (eczema).

Conditions

  • Atopic Dermatitis Eczema

Interventions

DRUG

Roflumilast Cream 0.15%

Roflumilast Cream 0.15% - Active

DRUG

Vehicle Cream

Cream - Vehicle

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
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2022-08-30
Completion
2022-08-30
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 NCT04773587 on ClinicalTrials.gov