NCT06527365

Safety and Efficacy of VDPHL01 in Males and Females With AGA

An Open-Label Multi-Dose Study to Evaluate the Safety and Efficacy of VDPHL01 in Male and Female Subjects With Androgenetic Alopecia

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Veradermics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of VDPHL01 in male and female subjects with Androgenetic Alopecia (AGA). AGA (or pattern of hair loss) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablets for males and VDPHL01 4.5 mg Tablets for females are an investigational oral drug to treat male and female pattern baldness. This multiple center, open-label, 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). Male subjects that meet the study eligibility criteria will be administered VDPHL01 once daily for 12 months. Female subjects that meet the study eligibility criteria will be administered VDPHL01 either once or twice daily for 12 months.

Conditions

• Androgenetic Alopecia
• AGA
• Male Pattern Baldness

Interventions

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

Timeline

• Start date: 2024-07-08
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2024-07-30
• Last updated: 2025-11-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study