NCT02275351

A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle- Controlled Study of the Safety, Tolerability, and Efficacy of 0.15% and 0.25% Concentrations of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Biosplice Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the safety, tolerability, and efficacy of topical SM04554 solution (0.15% and 0.25%) applied to the scalp of male subjects with Androgenetic Alopecia (AGA).

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
DRUG	SM04554	Topical solution, applied once a day
DRUG	Vehicle	Topical solution, applied once a day

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-10-27
• Last updated: 2020-02-17

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study