NCT06998056

Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis

A Phase 2, Open Label, 4-Week, Safety Study of Roflumilast Cream 0.05% Administered Once Daily in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Arcutis Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 3 Months – 2 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and tolerability of ARQ-151 cream 0.05% applied once a day for 4 weeks in infants with atopic dermatitis (eczema).

Detailed description

This study is an open label safety study in which ARQ-151 cream 0.05% is applied once a day for 4 weeks in infants with atopic dermatitis (eczema).

Conditions

• Atopic Dermatitis (Eczema)

Interventions

Type	Name	Description
DRUG	ARQ-151 cream 0.05%	ARQ-151 Cream 0.05% is applied once daily for 4 weeks in infants with atopic dermatitis (eczema).

Timeline

• Start date: 2025-06-09
• Primary completion: 2025-12-04
• Completion: 2025-12-04
• First posted: 2025-05-31
• Last updated: 2025-12-10

Locations

22 sites across 3 countries: United States, Canada, Dominican Republic

Regulatory

• FDA-regulated drug study