NCT04091646

Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Arcutis Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a parallel group, double blind, vehicle-controlled study assessed the safety and efficacy of roflumilast foam (ARQ-154) vs placebo foam in participants with seborrheic dermatitis.

Conditions

• Seborrheic Dermatitis

Interventions

Type	Name	Description
DRUG	Roflumilast Foam 0.3%	Roflumilast foam for topical application.
DRUG	Vehicle foam	Vehicle foam for topical application.

Timeline

• Start date: 2019-12-04
• Primary completion: 2020-08-18
• Completion: 2020-08-21
• First posted: 2019-09-17
• Last updated: 2023-07-03
• Results posted: 2023-07-03

Locations

24 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study