NCT05571943

A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis

A Multicenter, Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in the Treatment of Children, Adolescents and Adults With Mild to Moderate Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 542 (actual)
• Sponsor: Acrotech Biopharma Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate AD. The study will also evaluate the long-term efficacy of difamilast ointment 1%, including durability of response.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Difamilast	Difamilast Ointment 1%

Timeline

• Start date: 2022-09-15
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2022-10-07
• Last updated: 2024-08-09

Locations

63 sites across 1 country: United States

Regulatory

• FDA-regulated drug study