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
Sex
MALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Primary outcome measure(s)
Changes in non-vellus Target Area Hair Counts (TAHC) — Month 6 Change from baseline in non-vellus TAHC using digital image analysis at Month 6.
Subjects Evaluation of Treatment Benefit — Month 6 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.
Trial sites (44)
Facility
City
Region
Status
Site 73
Birmingham
Alabama
Site 89
Birmingham
Alabama
Site 77
Phoenix
Arizona
Site 69
Encino
California
Site 64
Manhattan Beach
California
Site 93
Northridge
California
Site 66
Santa Monica
California
Site 94
Thousand Oaks
California
Site 71
Boca Raton
Florida
Site 86
Coral Gables
Florida
Site 62
Coral Gables
Florida
Site 99
Miami
Florida
Site 54
Ocala
Florida
Site 96
Tamarac
Florida
Site 90
Sandy Springs
Georgia
Site 61
Chicago
Illinois
Site 53
Clarksville
Indiana
Site 55
Plainfield
Indiana
Site 79
Leawood
Kansas
Site 52
Louisville
Kentucky
Site 75
New Orleans
Louisiana
Site 84
Glenn Dale
Maryland
Site 87
Rockville
Maryland
Site 80
Chestnut Hill
Massachusetts
Site 59
Quincy
Massachusetts
Site 68
Clinton Township
Michigan
Site 83
Troy
Michigan
Site 82
Hickory
North Carolina
Site 92
Huntersville
North Carolina
Site 72
Cincinnati
Ohio
Site 57
Portland
Oregon
Site 81
East Greenwich
Rhode Island
Site 60
Anderson
South Carolina
Site 95
Hermitage
Tennessee
Site 76
Austin
Texas
Site 51
Austin
Texas
Site 74
College Station
Texas
Site 67
Dallas
Texas
Site 78
Plano
Texas
Site 88
San Antonio
Texas
+ 4 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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