Clinical trial NCT06972264: Safety and Efficacy of VDPHL01 in Males With AGA
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Androgenetic Alopecia
AGA
Male Pattern Baldness
Keywords: Hair Loss
Male Hair Loss
Lead sponsor: Veradermics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-14
Enrollment: 480
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 outcomes:
measure: Changes in non-vellus Target Area Hair Counts (TAHC)
timeFrame: Month 6
measure: Subjects Evaluation of Treatment Benefit
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 73
state: Alabama
city: Encino
country: United States
facility: Site 69
state: California
city: Manhattan Beach
country: United States
facility: Site 64
state: California
city: Santa Monica
country: United States
facility: Site 66
state: California
city: Boca Raton
country: United States
facility: Site 71
state: Florida
city: Coral Gables
country: United States
facility: Site 86
state: Florida
city: Coral Gables
country: United States
facility: Site 62
state: Florida
city: Chicago
country: United States
facility: Site 61
state: Illinois
city: Clarksville
country: United States
facility: Site 53
state: Indiana
city: Plainfield
country: United States
facility: Site 55
state: Indiana
city: Louisville
country: United States
facility: Site 52
state: Kentucky
city: New Orleans
country: United States
facility: Site 75
state: Louisiana
city: Rockville
country: United States
facility: Site 87
state: Maryland
city: Chestnut Hill
country: United States
facility: Site 80
state: Massachusetts
city: Quincy
country: United States
facility: Site 59
state: Massachusetts
city: Clinton Township
country: United States
facility: Site 68
state: Michigan
city: Troy
country: United States
facility: Site 83
state: Michigan
city: Cincinnati
country: United States
facility: Site 72
state: Ohio
city: Portland
country: United States
facility: Site 57
state: Oregon
city: Anderson
country: United States
facility: Site 60
state: South Carolina
city: Austin
country: United States
facility: Site 76
state: Texas
city: Austin
country: United States
facility: Site 51
state: Texas
city: Dallas
country: United States
facility: Site 67
state: Texas
city: Plano
country: United States
facility: Site 78
state: Texas
city: Norfolk
country: United States
facility: Site 63
state: Virginia
city: Mill Creek
country: United States
facility: Site 70
state: Washington
Study officials:
affiliation: Veradermics, Inc.
name: Reid Waldman, M.D.
role: STUDY_CHAIR
affiliation: Veradermics, Inc.
name: Timothy Durso, M.D.
role: STUDY_CHAIR
References: