NCT03315689

Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT)

A Randomized, Double-blind, Vehicle-controlled Multicenter Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ATI-50002 Topical Solution Administered Twice-Daily for 28 Days in Adult Subjects With Alopecia Universalis and Alopecia Totalis With a 12-Month Long-Term Open-Label Extension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Aclaris Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution compared to vehicle in subjects with AU and AT.

Detailed description

This study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution in patients with Alopecia Universalis and Alopecia Totalis. Concentrations of ATI-50002 in the blood and skin will be assessed after 28 days of treatment with ATI-50002 Topical Solution.

Conditions

• Alopecia Universalis (AU)
• Alopecia Totalis (AT)

Interventions

Type	Name	Description
DRUG	Vehicle	Vehicle Topical Solution
DRUG	ATI-50002	ATI-50002 Topical Solution

Timeline

• Start date: 2017-12-14
• Primary completion: 2019-06-20
• Completion: 2019-06-20
• First posted: 2017-10-20
• Last updated: 2020-07-02
• Results posted: 2020-07-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study