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.
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 normal 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 36
Birmingham
Alabama
Site 28
Phoenix
Arizona
Site 30
Fort Smith
Arkansas
Site 35
Rogers
Arkansas
Site 07
Fountain Valley
California
Site 02
Fremont
California
Site 34
Sherman Oaks
California
Site 21
Vista
California
Site 05
Castle Rock
Colorado
Site 24
Englewood
Colorado
Site 17
Aventura
Florida
Site 25
Brandon
Florida
Site 42
Hollywood
Florida
Site 03
Tampa
Florida
Site 43
Atlanta
Georgia
Site 31
Boise
Idaho
Site 23
Rolling Meadows
Illinois
Site 15
Indianapolis
Indiana
Site 32
New Albany
Indiana
Site 27
West Lafayette
Indiana
Site 41
Baton Rouge
Louisiana
Site 13
Covington
Louisiana
Site 12
Metairie
Louisiana
Site 22
Brighton
Massachusetts
Site 26
Clarkston
Michigan
Site 06
New Brighton
Minnesota
Site 18
Hackensack
New Jersey
Site 37
Kew Gardens
New York
Site 38
New York
New York
Site 39
Boardman
Ohio
Site 11
Columbus
Ohio
Site 08
Broomall
Pennsylvania
Site 10
Plymouth Meeting
Pennsylvania
Site 20
Greensville
South Carolina
Site 09
Knoxville
Tennessee
Site 16
Murfreesboro
Tennessee
Site 04
Nashville
Tennessee
Site 40
Bellaire
Texas
Site 44
Dallas
Texas
Site 14
Houston
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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