NCT04773600

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)

A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects With Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 683 (actual)
• Sponsor: Arcutis Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema). This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 0.15% cream or vehicle is applied once daily (qd) for 4 weeks by participants with atopic dermatitis.

Conditions

• Atopic Dermatitis Eczema

Interventions

Type	Name	Description
DRUG	Roflumilast Cream	Roflumilast cream 0.15% for topical application
DRUG	Vehicle cream	Vehicle cream for topical application

Timeline

• Start date: 2021-02-24
• Primary completion: 2022-09-29
• Completion: 2022-09-29
• First posted: 2021-02-26
• Last updated: 2024-10-04
• Results posted: 2024-10-04

Locations

53 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study