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Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis

NCT03916081 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2023-02-13

Study results available
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Summary

The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days by adolescents and adults with atopic dermatitis.

Conditions

Interventions

DRUG

Roflumilast Cream 0.05%

Roflumilast 0.05% cream for topical application

DRUG

Roflumilast Cream 0.15%

Roflumilast 0.15% cream for topical application

DRUG

Vehicle Cream

Inactive 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
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2019-11-04
Completion
2019-11-04
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT03916081 on ClinicalTrials.gov