NCT02503137

A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing

A Phase 2, Multicenter, Randomized, Double-Blind Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia (AGA) Analyzed by Biopsy of the Scalp Prior To and Post Dosing

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Biosplice Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety, tolerability, and efficacy of SM04554 at concentrations of 0.15% and 0.25%. Improved knowledge of the changes in hair counts and immunohistochemical analysis associated with androgenetic alopecia (AGA) before and after treatment with SM04554 and compared to placebo may lead to a greater understanding of the underlying mechanisms of action of SM04554.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
DRUG	Topical SM04554 solution
DRUG	Topical Vehicle solution

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-07-20
• Last updated: 2020-02-17

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study