NCT06724614

Efficacy and Safety of VDPHL01 in Males With AGA

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-dose Study to Evaluate the Efficacy and Safety of VDPHL01 in Male Subjects With Androgenetic Alopecia

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Veradermics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA). AGA (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablet is an investigational oral drug to treat male pattern baldness. This multi-center, double blind, study will last about 13 months and includes 11 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13). The first 7 visits will be part of the placebo-controlled period. The next 3 visits will be part of the treatment extension phase. All subjects will receive active drug in the treatment extension phase.

Conditions

• Androgenetic Alopecia
• AGA
• Male Pattern Baldness

Interventions

Type	Name	Description
DRUG	VDPHL01	VDPHL01 Extended Release (ER) Tablet
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-11-06
• Primary completion: 2026-02-01
• Completion: 2026-09-01
• First posted: 2024-12-09
• Last updated: 2025-11-06

Locations

44 sites across 1 country: United States

Regulatory

• FDA-regulated drug study