NCT05802173

Study of TDM-105795 Following Topical Administration in Male Subjects With Androgenetic Alopecia

A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Multi-dose Study to Evaluate the Efficacy and Safety of TDM-105795 in Male Subjects With Androgenetic Alopecia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Technoderma Medicines Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Randomized, double-blind, vehicle-controlled, parallel group, multi-dose study of TDM-105795 in male subjects with androgenetic alopecia

Detailed description

Protocol 239-11651-203 is a Phase 2 study entitled "A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Multi-Dose Study to Evaluate the Efficacy and Safety of TDM-105795 in Male Subjects with Androgenetic Alopecia" Eligible subjects will be randomized (1:1:1) to 1 of the 3 groups (low dose vs high dose vs placebo) and treated for 16 weeks.

Conditions

• Alopecia, Androgenetic

Interventions

Type	Name	Description
DRUG	TDM-105795, 0.0025%	The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
DRUG	TDM-105795, 0.02%	The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
DRUG	TDM-105795 topical vehicle solution	The assigned placebo will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.

Timeline

• Start date: 2023-03-06
• Primary completion: 2023-11-08
• Completion: 2024-01-29
• First posted: 2023-04-06
• Last updated: 2025-11-12
• Results posted: 2025-11-12

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study