Efficacy and Safety 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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Androgenetic Alopecia; AGA; Male Pattern Baldness
• Intervention / Treatment: Drug: Placebo; Drug: VDPHL01

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35203
      • Site 36
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Site 28
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Site 30
    • Rogers, Arkansas, United States, 72758
      • Site 35
  • California
    • Fountain Valley, California, United States, 92728
      • Site 07
    • Fremont, California, United States, 94538
      • Site 02
    • Sherman Oaks, California, United States, 91403
      • Site 34
    • Vista, California, United States, 92083
      • Site 21
  • Colorado
    • Castle Rock, Colorado, United States, 80109
      • Site 05
    • Englewood, Colorado, United States, 80111
      • Site 24
  • Florida
    • Aventura, Florida, United States, 33180
      • Site 17
    • Brandon, Florida, United States, 33511
      • Site 25
    • Hollywood, Florida, United States, 33021
      • Site 42
    • Tampa, Florida, United States, 33613
      • Site 03
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Site 43
  • Idaho
    • Boise, Idaho, United States, 83704
      • Site 31
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Site 23
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Site 15
    • New Albany, Indiana, United States, 47150
      • Site 32
    • West Lafayette, Indiana, United States, 47906
      • Site 27
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Site 41
    • Covington, Louisiana, United States, 70433
      • Site 13
    • Metairie, Louisiana, United States, 70006
      • Site 12
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Site 22
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Site 26
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Site 06
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Site 18
  • New York
    • Kew Gardens, New York, United States, 11415
      • Site 37
    • New York, New York, United States, 10075
      • Site 38
  • Ohio
    • Boardman, Ohio, United States, 44512
      • Site 39
    • Columbus, Ohio, United States, 43215
      • Site 11
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19073
      • Site 08
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Site 10
  • South Carolina
    • Greensville, South Carolina, United States, 29615
      • Site 20
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Site 09
    • Murfreesboro, Tennessee, United States, 37130
      • Site 16
    • Nashville, Tennessee, United States, 37215
      • Site 04
  • Texas
    • Bellaire, Texas, United States, 77401
      • Site 40
    • Dallas, Texas, United States, 75231
      • Site 44
    • Houston, Texas, United States, 77056
      • Site 14
  • Utah
    • West Jordan, Utah, United States, 84095
      • Site 19
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Site 29
  • Washington
    • Seattle, Washington, United States, 98168
      • Site 33
    • Spokane, Washington, United States, 99202
      • Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VDHPL01 BID; VDPHL01 will be taken orally twice a day, once in the AM and once in the PM.	Drug: VDPHL01; VDPHL01 Extended Release (ER) Tablet
Placebo Comparator: Placebo BID with treatment extension to VDPHL01 BID; Placebo 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.	Drug: Placebo; Placebo
Experimental: VDPHL01 QD and Placebo QD; 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.	Drug: VDPHL01; VDPHL01 Extended Release (ER) Tablet
Placebo Comparator: Placebo BID with treatment extension to VDPHL01 QD and Placebo QD; Placebo 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.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Veradermics, Inc.
• Investigators: Study Chair: Reid Waldman, M.D., Veradermics, Inc.; Study Chair: Timothy Durso, M.D., Veradermics, Inc.

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Hair Loss; Male Hair Loss
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 250-13951-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No