NCT04445987

Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

A Phase 2, Multicenter, Open-Label Study of the Long-Term Safety of ARQ-154 Foam 0.3% in Subjects With Seborrheic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Arcutis Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 9 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, long-term safety study of roflumilast ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA). Study was applied topically once daily for 52 weeks. Cohort 1 subjects are rollover subjects from study ARQ-154-203 (NCT04091646) and were rolled into treatment in the current study without interruption. Cohort 2 includes participants from ARQ-154-203 who began treatment in the current study after a gap from completing treatment in the prior study.

Conditions

• Seborrheic Dermatitis

Interventions

Type	Name	Description
DRUG	ARQ-154	ARQ-154 foam 0.3% applied once daily for 52 weeks

Timeline

• Start date: 2020-06-12
• Primary completion: 2022-11-19
• Completion: 2022-11-19
• First posted: 2020-06-24
• Last updated: 2024-06-11
• Results posted: 2024-06-11

Locations

39 sites across 1 country: United States

Regulatory

• FDA-regulated drug study