Safety and Efficacy of VDPHL01 in Males With AGA

Last updated: May 6, 2025
Sponsor: Veradermics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Male Pattern Baldness

Scalp Disorders

Hair Loss

Treatment

Placebo

VDPHL01

Clinical Study ID

NCT06972264
250-13951-304
  • Ages 18-65
  • Male

Study 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

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 withthe same hairstyle, hair length, and hair color throughout the study; maintainconsistent 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 theprotocol.

Exclusion

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 thanAGA;

  • Subject has a current or recent history of dietary or weight changes, including useof 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 beforescreening:

  • Subject has used hormone replacement therapy or hormonal modulators within 6months prior to screening

  • Subject has used oral treatments for hair growth or that can affect hairgrowth, including systemic retinoids, within 6 months of screening

  • Subject has used systemic calcium channel blockers or beta blockers within 12weeks prior to screening

  • Subject has used systemic cimetidine, ketoconazole, diazoxide, orcorticosteroids (including intramuscular, intraarticular, and intralesionalinjections) within 12 weeks prior to screening

  • Subject has had any scalp procedures, including surgical, laser, light orenergy treatments, micro-needling, injections, platelet rich plasma within 6months prior to screening

  • Subject has used any topical scalp treatments for hair growth within 12 weeksprior to screening

  • Subject has used any other therapy with any medication either topical or oral thatmight, in the investigator's opinion, interfere with the study;

  • Subject has any other condition that, in the investigator's opinion, interfere withthe study

Study Design

Total Participants: 480
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
March 11, 2025
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Site 73

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Site 69

    Encino, California 91436
    United States

    Active - Recruiting

  • Site 64

    Manhattan Beach, California 90266
    United States

    Active - Recruiting

  • Site 66

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Site 71

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Site 62

    Coral Gables, Florida 33146
    United States

    Active - Recruiting

  • Site 86

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Site 61

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Site 53

    Clarksville, Indiana 47129
    United States

    Active - Recruiting

  • Site 55

    Plainfield, Indiana 46168
    United States

    Active - Recruiting

  • Site 52

    Louisville, Kentucky 40241
    United States

    Active - Recruiting

  • Site 75

    New Orleans, Louisiana 70124
    United States

    Active - Recruiting

  • Site 87

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • Site 80

    Chestnut Hill, Massachusetts 02467
    United States

    Active - Recruiting

  • Site 59

    Quincy, Massachusetts 02169
    United States

    Active - Recruiting

  • Site 68

    Clinton Township, Michigan 48038
    United States

    Active - Recruiting

  • Site 83

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • Site 72

    Cincinnati, Ohio 45236
    United States

    Active - Recruiting

  • Site 57

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Site 60

    Anderson, South Carolina 29625
    United States

    Active - Recruiting

  • Site 51

    Austin, Texas 78759
    United States

    Active - Recruiting

  • Site 76

    Austin, Texas 78746
    United States

    Active - Recruiting

  • Site 67

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Site 78

    Plano, Texas 75024
    United States

    Active - Recruiting

  • Site 63

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Site 70

    Mill Creek, Washington 98012
    United States

    Active - Recruiting

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