Safety and Efficacy of VDPHL01 in Females With Androgenetic Alopecia (AGA)

Last updated: November 18, 2025
Sponsor: Veradermics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Male Pattern Baldness

Hair Loss

Alopecia

Treatment

VDPHL01 QD

VDPHL01 BID

Placebo

Clinical Study ID

NCT07146022
250-13951-306
  • Ages 18-65
  • Female

Study Summary

This study will evaluate the safety and efficacy of VDPHL01 in female subjects with Androgenetic Alopecia (AGA).

AGA is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormones) that causes hair loss. VDPHL01 is an investigational oral drug to treat AGA.

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 a female 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 and can read,understand, and complete the 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 baseline;

  • 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 oralthat might, in the investigator's opinion, interfere with the study;

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

Study Design

Total Participants: 552
Treatment Group(s): 3
Primary Treatment: VDPHL01 QD
Phase: 3
Study Start date:
July 25, 2025
Estimated Completion Date:
January 31, 2028

Study Description

Not required.

Connect with a study center

  • Site 73

    Birmingham 4049979, Alabama 4829764 35209
    United States

    Active - Recruiting

  • Site 89

    Birmingham 4049979, Alabama 4829764 35244
    United States

    Active - Recruiting

  • Site 77

    Phoenix 5308655, Arizona 5551752 85006
    United States

    Active - Recruiting

  • Site 30

    Fort Smith 4111410, Arkansas 4099753 72916
    United States

    Active - Recruiting

  • Site 69

    Encino 5346649, California 5332921 91436
    United States

    Active - Recruiting

  • Site 2

    Fremont 5350734, California 5332921 94538
    United States

    Active - Recruiting

  • Site 64

    Manhattan Beach 5370082, California 5332921 90266
    United States

    Active - Recruiting

  • Site 93

    Northridge 5377985, California 5332921 91324
    United States

    Active - Recruiting

  • Site 66

    Santa Monica 5393212, California 5332921 90404
    United States

    Active - Recruiting

  • Site 34

    Sherman Oaks 5395244, California 5332921 91403
    United States

    Active - Recruiting

  • Site 94

    Thousand Oaks 5402405, California 5332921 91320
    United States

    Active - Recruiting

  • Site 21

    Vista 5406602, California 5332921 92083
    United States

    Active - Recruiting

  • Site 5

    Castle Rock 5416329, Colorado 5417618 80109
    United States

    Active - Recruiting

  • Site 24

    Greenwood Village 5423908, Colorado 5417618 80111
    United States

    Active - Recruiting

  • Site 17

    Aventura 4146429, Florida 4155751 33180
    United States

    Active - Recruiting

  • Site 71

    Boca Raton 4148411, Florida 4155751 33486
    United States

    Active - Recruiting

  • Site 62

    Coral Gables 4151871, Florida 4155751 33146
    United States

    Active - Recruiting

  • Site 86

    Coral Gables 4151871, Florida 4155751 33134
    United States

    Active - Recruiting

  • Site 99

    Miami 4164138, Florida 4155751 33173
    United States

    Active - Recruiting

  • Site 54

    Ocala 4166673, Florida 4155751 34470
    United States

    Active - Recruiting

  • Site 43

    Atlanta 4180439, Georgia 4197000 30329
    United States

    Active - Recruiting

  • Site 90

    Sandy Springs 4221333, Georgia 4197000 30328
    United States

    Active - Recruiting

  • Site 31

    Boise 5586437, Idaho 5596512 83704
    United States

    Active - Recruiting

  • Site 61

    Chicago 4887398, Illinois 4896861 60610
    United States

    Site Not Available

  • Site 53

    Clarksville 4255836, Indiana 4921868 47129
    United States

    Active - Recruiting

  • Site 15

    Indianapolis 4259418, Indiana 4921868 46250
    United States

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  • Site 32

    New Albany 4262045, Indiana 4921868 47150
    United States

    Active - Recruiting

  • Site 55

    Plainfield 4263108, Indiana 4921868 46168
    United States

    Active - Recruiting

  • Site 27

    West Lafayette 4928096, Indiana 4921868 47906
    United States

    Active - Recruiting

  • Site 79

    Leawood 4274317, Kansas 4273857 66211
    United States

    Active - Recruiting

  • Site 52

    Louisville 4299276, Kentucky 6254925 40241
    United States

    Active - Recruiting

  • Site 41

    Baton Rouge 4315588, Louisiana 4331987 70809
    United States

    Active - Recruiting

  • Site 13

    Covington 4321005, Louisiana 4331987 70433
    United States

    Active - Recruiting

  • Site 12

    Metairie 4333177, Louisiana 4331987 70006
    United States

    Active - Recruiting

  • Site 75

    New Orleans 4335045, Louisiana 4331987 70124
    United States

    Active - Recruiting

  • Site 84

    Glenn Dale 4356289, Maryland 4361885 20769
    United States

    Active - Recruiting

  • Site 87

    Rockville 4367175, Maryland 4361885 20850
    United States

    Active - Recruiting

  • Site 22

    Brighton 4931353, Massachusetts 6254926 02135
    United States

    Active - Recruiting

  • Site 80

    Chestnut Hill 4932957, Massachusetts 6254926 02467
    United States

    Active - Recruiting

  • Site 59

    Quincy 4948247, Massachusetts 6254926 02169
    United States

    Active - Recruiting

  • Site 26

    Clarkston 4988997, Michigan 5001836 48346
    United States

    Active - Recruiting

  • Site 68

    Clinton Township 4989133, Michigan 5001836 48038
    United States

    Active - Recruiting

  • Site 83

    Southfield 5010636, Michigan 5001836 48034
    United States

    Site Not Available

  • Site 98

    Medina 5037186, Minnesota 5037779 55340
    United States

    Site Not Available

  • Site 56

    Minneapolis 5037649, Minnesota 5037779 55455
    United States

    Active - Recruiting

  • Site 6

    New Brighton 5039080, Minnesota 5037779 55112
    United States

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  • Site 18

    Hackensack 5098706, New Jersey 5101760 07601
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    Active - Recruiting

  • Site 37

    Kew Gardens 5123344, New York 5128638 11415
    United States

    Active - Recruiting

  • Site 97

    New York 5128581, New York 5128638 10003
    United States

    Site Not Available

  • Site 82

    Hickory 4470778, North Carolina 4482348 28602
    United States

    Active - Recruiting

  • Site 92

    Huntersville 4472370, North Carolina 4482348 28078
    United States

    Active - Recruiting

  • Site 39

    Boardman 5147784, Ohio 5165418 44512
    United States

    Active - Recruiting

  • Site 72

    Cincinnati 4508722, Ohio 5165418 45236
    United States

    Active - Recruiting

  • Site 11

    Columbus 4509177, Ohio 5165418 43215
    United States

    Active - Recruiting

  • Site 57

    Portland 5746545, Oregon 5744337 97210
    United States

    Active - Recruiting

  • Site 60

    Anderson 4569298, South Carolina 4597040 29621
    United States

    Active - Recruiting

  • Site 95

    Hermitage 4628929, Tennessee 4662168 37076
    United States

    Active - Recruiting

  • Site 9

    Knoxville 4634946, Tennessee 4662168 37909
    United States

    Active - Recruiting

  • Site 4

    Nashville 4644585, Tennessee 4662168 37215
    United States

    Active - Recruiting

  • Site 76

    Austin 4671654, Texas 4736286 78746
    United States

    Active - Recruiting

  • Site 74

    College Station 4682464, Texas 4736286 77845
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    Active - Recruiting

  • Site 67

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • Site 14

    Houston 4699066, Texas 4736286 77056
    United States

    Terminated

  • Site 88

    San Antonio 4726206, Texas 4736286 78218
    United States

    Active - Recruiting

  • Site 91

    Sugar Land 4734825, Texas 4736286 77479
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  • Site 19

    South Jordan 5781770, Utah 5549030 84095
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  • Site 29

    Forest 4759556, Virginia 6254928 24551
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  • Site 63

    Norfolk 4776222, Virginia 6254928 23502
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  • Site 85

    Norfolk 4776222, Virginia 6254928 23502
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    Active - Recruiting

  • Site 33

    Burien 5788516, Washington 5815135 98168
    United States

    Active - Recruiting

  • Site 70

    Mill Creek 5803457, Washington 5815135 98012
    United States

    Active - Recruiting

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