NCT03468855

A Study of ATI-50002 Topical Solution for the Treatment of Vitiligo

An Open-Label Pilot Study of the Safety, Tolerability and Efficacy of ATI-50002 Topical Solution Administered Twice-Daily in Adult Subjects With Non-Segmental Facial Vitiligo

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Aclaris Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to assess the safety, tolerability and efficacy of ATI-50002 Topical Solution, 0.46% in subjects with non-segmental facial vitiligo.

Detailed description

This is a multicenter, open-label study designed to evaluate the safety, tolerability and efficacy of ATI-50002 Topical Solution 0.46% in subjects with non-segmental facial vitiligo. Subjects will be required to have a clinical diagnosis of non-segmental facial vitiligo effecting at least 0.25% of total body surface area (TBSA) (excluding upper and lower eyelids, mucosal lip areas, and forehead and chin areas covered by the stereotactic positioning device for photography) with at least one area of the face with normal pigmentation. Twenty-four eligible subjects will receive ATI-50002 Topical Solution, 0.46%, BID for 24 weeks.

Conditions

• Vitiligo

Interventions

Type	Name	Description
DRUG	ATI-50002 topical solution	Topical Solution administered twice daily

Timeline

• Start date: 2018-03-19
• Primary completion: 2019-10-16
• Completion: 2019-10-16
• First posted: 2018-03-19
• Last updated: 2020-11-30
• Results posted: 2020-11-30

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study