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Efficacy and Safety of VDPHL01 in Males With AGA
Sponsor: Veradermics, Inc.
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.
Official title: 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
Key Details
Gender
MALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
480
Start Date
2024-11-06
Completion Date
2026-09
Last Updated
2025-11-06
Healthy Volunteers
No
Interventions
VDPHL01
VDPHL01 Extended Release (ER) Tablet
Placebo
Placebo
Locations (44)
Site 36
Birmingham, Alabama, United States
Site 28
Phoenix, Arizona, United States
Site 30
Fort Smith, Arkansas, United States
Site 35
Rogers, Arkansas, United States
Site 07
Fountain Valley, California, United States
Site 02
Fremont, California, United States
Site 34
Sherman Oaks, California, United States
Site 21
Vista, California, United States
Site 05
Castle Rock, Colorado, United States
Site 24
Englewood, Colorado, United States
Site 17
Aventura, Florida, United States
Site 25
Brandon, Florida, United States
Site 42
Hollywood, Florida, United States
Site 03
Tampa, Florida, United States
Site 43
Atlanta, Georgia, United States
Site 31
Boise, Idaho, United States
Site 23
Rolling Meadows, Illinois, United States
Site 15
Indianapolis, Indiana, United States
Site 32
New Albany, Indiana, United States
Site 27
West Lafayette, Indiana, United States
Site 41
Baton Rouge, Louisiana, United States
Site 13
Covington, Louisiana, United States
Site 12
Metairie, Louisiana, United States
Site 22
Brighton, Massachusetts, United States
Site 26
Clarkston, Michigan, United States
Site 06
New Brighton, Minnesota, United States
Site 18
Hackensack, New Jersey, United States
Site 37
Kew Gardens, New York, United States
Site 38
New York, New York, United States
Site 39
Boardman, Ohio, United States
Site 11
Columbus, Ohio, United States
Site 08
Broomall, Pennsylvania, United States
Site 10
Plymouth Meeting, Pennsylvania, United States
Site 20
Greensville, South Carolina, United States
Site 09
Knoxville, Tennessee, United States
Site 16
Murfreesboro, Tennessee, United States
Site 04
Nashville, Tennessee, United States
Site 40
Bellaire, Texas, United States
Site 44
Dallas, Texas, United States
Site 14
Houston, Texas, United States
Site 19
West Jordan, Utah, United States
Site 29
Lynchburg, Virginia, United States
Site 33
Seattle, Washington, United States
Site 01
Spokane, Washington, United States