Clinical trial NCT06724614: Efficacy and Safety 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: PHASE2
PHASE3
Conditions: Androgenetic Alopecia
AGA
Male Pattern Baldness
Keywords: Hair Loss
Male Hair Loss
Lead sponsor: Veradermics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-09
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).

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 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 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 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 36
state: Alabama
city: Phoenix
country: United States
facility: Site 28
state: Arizona
city: Fort Smith
country: United States
facility: Site 30
state: Arkansas
city: Rogers
country: United States
facility: Site 35
state: Arkansas
city: Fountain Valley
country: United States
facility: Site 07
state: California
city: Fremont
country: United States
facility: Site 02
state: California
city: Sherman Oaks
country: United States
facility: Site 34
state: California
city: Vista
country: United States
facility: Site 21
state: California
city: Castle Rock
country: United States
facility: Site 05
state: Colorado
city: Englewood
country: United States
facility: Site 24
state: Colorado
city: Aventura
country: United States
facility: Site 17
state: Florida
city: Brandon
country: United States
facility: Site 25
state: Florida
city: Hollywood
country: United States
facility: Site 42
state: Florida
city: Tampa
country: United States
facility: Site 03
state: Florida
city: Atlanta
country: United States
facility: Site 43
state: Georgia
city: Boise
country: United States
facility: Site 31
state: Idaho
city: Rolling Meadows
country: United States
facility: Site 23
state: Illinois
city: Indianapolis
country: United States
facility: Site 15
state: Indiana
city: New Albany
country: United States
facility: Site 32
state: Indiana
city: West Lafayette
country: United States
facility: Site 27
state: Indiana
city: Baton Rouge
country: United States
facility: Site 41
state: Louisiana
city: Covington
country: United States
facility: Site 13
state: Louisiana
city: Metairie
country: United States
facility: Site 12
state: Louisiana
city: Brighton
country: United States
facility: Site 22
state: Massachusetts
city: Clarkston
country: United States
facility: Site 26
state: Michigan
city: New Brighton
country: United States
facility: Site 06
state: Minnesota
city: Hackensack
country: United States
facility: Site 18
state: New Jersey
city: Kew Gardens
country: United States
facility: Site 37
state: New York
city: New York
country: United States
facility: Site 38
state: New York
city: Boardman
country: United States
facility: Site 39
state: Ohio
city: Columbus
country: United States
facility: Site 11
state: Ohio
city: Broomall
country: United States
facility: Site 08
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Site 10
state: Pennsylvania
city: Greensville
country: United States
facility: Site 20
state: South Carolina
city: Knoxville
country: United States
facility: Site 09
state: Tennessee
city: Murfreesboro
country: United States
facility: Site 16
state: Tennessee
city: Nashville
country: United States
facility: Site 04
state: Tennessee
city: Bellaire
country: United States
facility: Site 40
state: Texas
city: Dallas
country: United States
facility: Site 44
state: Texas
city: Houston
country: United States
facility: Site 14
state: Texas
city: West Jordan
country: United States
facility: Site 19
state: Utah
city: Lynchburg
country: United States
facility: Site 29
state: Virginia
city: Seattle
country: United States
facility: Site 33
state: Washington
city: Spokane
country: United States
facility: Site 01
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: