NCT03742518

A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia

Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 0.15% & 0.25% Concentrations of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 675 (actual)
• Sponsor: Biosplice Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This multi-center, randomized, double-blind, placebo-controlled study, conducted in Turkey, will assess the efficacy and safety of topical SM04554 solution (0.15% and 0.25%) applied daily to the scalp of male androgenetic alopecia (AGA) subjects.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
DRUG	Topical SM04554 solution	Study medication application will be performed by the individual subject at approximately the same time each day.
DRUG	Topical SM04554 solution	Study medication application will be performed by the individual subject at approximately the same time each day.
DRUG	Topical vehicle solution	Vehicle solution application will be performed by the individual subject at approximately the same time each day.

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-11-15
• Last updated: 2021-12-28

Locations

14 sites across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study