NCT03916081

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

A Phase 2, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% and ARQ-151 Cream 0.15% Administered QD (Quaque Die) in Adolescent and Adult Subjects With Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Arcutis Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a parallel group, double blind, vehicle-controlled study in which roflumilast cream 0.05% or 0.15% or vehicle is applied QD x 28 days to adolescent and adult subjects with atopic dermatitis. A subset of subjects will have serial PK testing, which will include the first few adolescents and adults enrolled in the study.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-05-31
• Primary completion: 2019-11-04
• Completion: 2019-11-04
• First posted: 2019-04-16
• Last updated: 2023-02-13
• Results posted: 2023-02-13

Locations

20 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study