Safety and Efficacy 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
1 other identifier
interventional
480
1 country
44
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2025
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2025
CompletedFirst Submitted
Initial submission to the registry
May 6, 2025
CompletedFirst Posted
Study publicly available on registry
May 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
February 12, 2026
February 1, 2026
1.7 years
May 6, 2025
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in non-vellus Target Area Hair Counts (TAHC)
Change from baseline in non-vellus TAHC using digital image analysis at Month 6.
Month 6
Subjects Evaluation of Treatment Benefit
Subjects will rate their treatment benefit by responding to a hair assessment scale. The proportion of subjects by each response category will be reported at Month 6.
Month 6
Study Arms (4)
VDHPL01 BID
EXPERIMENTALVDPHL01 will be taken orally twice a day, once in the AM and once in the PM.
VDPHL01 QD and Placebo QD
EXPERIMENTALPlacebo will be taken orally once a day in the AM or PM. VDPHL01 will be taken orally once a day in the AM or PM.
Placebo BID with treatment extension to VDPHL01 BID
PLACEBO COMPARATORPlacebo 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 BID with treatment extension to VDPHL01 QD and Placebo QD
PLACEBO COMPARATORPlacebo 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 or PM. VDPHL01 will be taken orally once a day in the AM or PM.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Subject has uncontrolled blood pressure or orthostatic hypotension;
- Subject has symptoms or history of certain heart or thyroid conditions;
- Subject has a history of or active hair loss due to conditions/diseases other than AGA;
- Subject has a current or recent history of dietary or weight changes, including use of GLP-1 agonists;
- Subject has been diagnosed with COVID-19 within 16 weeks of screening;
- Subject has had previous radiation of the scalp;
- Use of any of the following treatments within the indicated washout period before screening:
- Subject has used hormone replacement therapy or hormonal modulators within 6 months prior to screening
- Subject has used oral treatments for hair growth or that can affect hair growth, including systemic retinoids, within 6 months of screening
- Subject has used systemic calcium channel blockers or beta blockers within 12 weeks prior to screening
- Subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12 weeks prior to screening
- Subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, injections, platelet rich plasma within 6 months prior to screening
- Subject has used any topical scalp treatments for hair growth within 12 weeks prior to screening
- Subject has used any other therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study;
- Subject has any other condition that, in the investigator's opinion, interfere with the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Site 73
Birmingham, Alabama, 35209, United States
Site 89
Birmingham, Alabama, 35244, United States
Site 77
Phoenix, Arizona, 85006, United States
Site 69
Encino, California, 91436, United States
Site 64
Manhattan Beach, California, 90266, United States
Site 93
Northridge, California, 91324, United States
Site 66
Santa Monica, California, 90404, United States
Site 94
Thousand Oaks, California, 91320, United States
Site 71
Boca Raton, Florida, 33486, United States
Site 86
Coral Gables, Florida, 33134, United States
Site 62
Coral Gables, Florida, 33146, United States
Site 99
Miami, Florida, 33173, United States
Site 54
Ocala, Florida, 34470, United States
Site 96
Tamarac, Florida, 33321, United States
Site 90
Sandy Springs, Georgia, 30328, United States
Site 61
Chicago, Illinois, 60611, United States
Site 53
Clarksville, Indiana, 47129, United States
Site 55
Plainfield, Indiana, 46168, United States
Site 79
Leawood, Kansas, 66211, United States
Site 52
Louisville, Kentucky, 40241, United States
Site 75
New Orleans, Louisiana, 70124, United States
Site 84
Glenn Dale, Maryland, 20769, United States
Site 87
Rockville, Maryland, 20850, United States
Site 80
Chestnut Hill, Massachusetts, 02467, United States
Site 59
Quincy, Massachusetts, 02169, United States
Site 68
Clinton Township, Michigan, 48038, United States
Site 83
Troy, Michigan, 48084, United States
Site 82
Hickory, North Carolina, 28602, United States
Site 92
Huntersville, North Carolina, 28078, United States
Site 72
Cincinnati, Ohio, 45236, United States
Site 57
Portland, Oregon, 97210, United States
Site 81
East Greenwich, Rhode Island, 02818, United States
Site 60
Anderson, South Carolina, 29625, United States
Site 95
Hermitage, Tennessee, 37076, United States
Site 76
Austin, Texas, 78746, United States
Site 51
Austin, Texas, 78759, United States
Site 74
College Station, Texas, 77845, United States
Site 67
Dallas, Texas, 75230, United States
Site 78
Plano, Texas, 75024, United States
Site 88
San Antonio, Texas, 78218, United States
Site 91
Sugarland, Texas, 77479, United States
Site 63
Norfolk, Virginia, 23502, United States
Site 85
Norfolk, Virginia, 23502, United States
Site 70
Mill Creek, Washington, 98012, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Reid Waldman, M.D.
Veradermics, Inc.
- STUDY CHAIR
Timothy Durso, M.D.
Veradermics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2025
First Posted
May 14, 2025
Study Start
March 11, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
July 1, 2027
Last Updated
February 12, 2026
Record last verified: 2026-02