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: Recruiting
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Subject is male aged 18-65 years old;
• Subject has a clinical diagnosis of mild to moderate AGA;
• Subject is in good general health and has adequate renal and hepatic function;
• Subject is willing to maintain at least 1/4 inch length hair during the study with the same hairstyle, hair length, and hair color throughout the study; maintain consistent use of general hair care products and regimen through the entire study;
• Subject is willing and able to administer the test article as directed read, understand, and complete required questionnaires in English;
• Subject is willing and able to swallow study drug whole;
• Subject agrees to have a micro dot tattoo placed on their scalp;
• Subject agrees to have this area photographed at study visits as indicated in the protocol.
Locations
United States
Alabama
Site 73
RECRUITING
Birmingham
Site 89
RECRUITING
Birmingham
Arizona
Site 77
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Phoenix
California
Site 69
RECRUITING
Encino
Site 64
RECRUITING
Manhattan Beach
Site 93
RECRUITING
Northridge
Site 66
RECRUITING
Santa Monica
Site 94
RECRUITING
Thousand Oaks
Florida
Site 71
RECRUITING
Boca Raton
Site 62
RECRUITING
Coral Gables
Site 86
RECRUITING
Coral Gables
Site 54
RECRUITING
Ocala
Georgia
Site 90
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Sandy Springs
Illinois
Site 61
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Chicago
Indiana
Site 53
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Clarksville
Site 55
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Plainfield
Kansas
Site 79
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Leawood
Kentucky
Site 52
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Louisville
Louisiana
Site 75
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New Orleans
Massachusetts
Site 80
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Chestnut Hill
Site 59
RECRUITING
Quincy
Maryland
Site 84
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Glenn Dale
Site 87
RECRUITING
Rockville
Michigan
Site 68
RECRUITING
Clinton Township
Site 83
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Troy
North Carolina
Site 82
RECRUITING
Hickory
Site 92
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Huntersville
Ohio
Site 72
RECRUITING
Cincinnati
Oregon
Site 57
RECRUITING
Portland
Rhode Island
Site 81
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East Greenwich
South Carolina
Site 60
RECRUITING
Anderson
Texas
Site 51
RECRUITING
Austin
Site 76
RECRUITING
Austin
Site 74
RECRUITING
College Station
Site 67
RECRUITING
Dallas
Site 78
RECRUITING
Plano
Site 88
RECRUITING
San Antonio
Site 91
RECRUITING
Sugarland
Virginia
Site 63
RECRUITING
Norfolk
Site 85
RECRUITING
Norfolk
Washington
Site 70
RECRUITING
Mill Creek
Contact Information
Primary
Kate Mateja, MBA
clinicalresearch@therapeuticsinc.com
858-571-1800
Time Frame
Start Date:2025-03-11
Estimated Completion Date:2026-11
Participants
Target number of participants:480
Treatments
Experimental: VDHPL01 BID
VDPHL01 will be taken orally twice a day, once in the AM and once in the PM.
Experimental: VDPHL01 QD and Placebo QD
Placebo will be taken orally once a day in the AM. VDPHL01 will be taken orally once a day in the PM.
Placebo_comparator: Placebo BID with treatment extension to VDPHL01 BID
Placebo will be taken orally twice a day, once in the AM and once in the PM for the first 6 months of the study. After month 6, VDPHL01 will be taken orally twice a day, once in the AM and once in the PM.
Placebo_comparator: Placebo BID with treatment extension to VDPHL01 QD and Placebo QD
Placebo will be taken orally twice a day, once in the AM and once in the PM for the first 6 months of the study. After month 6, placebo will be taken orally once a day in the AM. VDPHL01 will be taken orally once a day in the PM.