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NCT07146022PHASE3Recruiting

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

Veradermics, Inc.

Start Date

7/25/2025

Completion Date

1/1/2028

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).

Detailed Description

Not required.

Eligibility Criteria

Age Range: 18 years to 65 years

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 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 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 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 baseline; * 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

Interventions

DRUG

VDPHL01 QD

DRUG

Placebo

DRUG

VDPHL01 BID

DRUG

Placebo

Interested in This Trial?

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Conditions

Androgenetic Alopecia (AGA)Androgenetic AlopeciaAGAFemale Androgenetic AlopeciaHair Loss

Locations

Site 73

Birmingham, Alabama 35209

United States

Site 89

Birmingham, Alabama 35244

United States

Site 77

Phoenix, Arizona 85006

United States

Site 30

Fort Smith, Arkansas 72916

United States

Site 69

Encino, California 91436

United States

Site 2

Fremont, California 94538

United States

Site 64

Manhattan Beach, California 90266

United States

Site 93

Northridge, California 91324

United States

Site 66

Santa Monica, California 90404

United States

Site 34

Sherman Oaks, California 91403

United States

Site 94

Thousand Oaks, California 91320

United States

Site 21

Vista, California 92083

United States

Site 5

Castle Rock, Colorado 80109

United States

Site 24

Greenwood Village, Colorado 80111

United States

Site 17

Aventura, Florida 33180

United States

Site 71

Boca Raton, Florida 33486

United States

Site 86

Coral Gables, Florida 33134

United States

Site 62

Coral Gables, Florida 33146

United States

Site 99

Miami, Florida 33173

United States

Site 54

Ocala, Florida 34470

United States

Site 43

Atlanta, Georgia 30329

United States

Site 90

Sandy Springs, Georgia 30328

United States

Site 31

Boise, Idaho 83704

United States

Site 61

Chicago, Illinois 60610

United States

Site 53

Clarksville, Indiana 47129

United States

Site 15

Indianapolis, Indiana 46250

United States

Site 32

New Albany, Indiana 47150

United States

Site 55

Plainfield, Indiana 46168

United States

Site 27

West Lafayette, Indiana 47906

United States

Site 79

Leawood, Kansas 66211

United States

Site 52

Louisville, Kentucky 40241

United States

Site 41

Baton Rouge, Louisiana 70809

United States

Site 13

Covington, Louisiana 70433

United States

Site 12

Metairie, Louisiana 70006

United States

Site 75

New Orleans, Louisiana 70124

United States

Site 84

Glenn Dale, Maryland 20769

United States

Site 87

Rockville, Maryland 20850

United States

Site 22

Brighton, Massachusetts 02135

United States

Site 80

Chestnut Hill, Massachusetts 02467

United States

Site 59

Quincy, Massachusetts 02169

United States

Site 26

Clarkston, Michigan 48346

United States

Site 68

Clinton Township, Michigan 48038

United States

Site 83

Southfield, Michigan 48034

United States

Site 98

Medina, Minnesota 55340

United States

Site 56

Minneapolis, Minnesota 55455

United States

Site 6

New Brighton, Minnesota 55112

United States

Site 18

Hackensack, New Jersey 07601

United States

Site 37

Kew Gardens, New York 11415

United States

Site 97

New York, New York 10003

United States

Site 82

Hickory, North Carolina 28602

United States

Site 92

Huntersville, North Carolina 28078

United States

Site 39

Boardman, Ohio 44512

United States

Site 72

Cincinnati, Ohio 45236

United States

Site 11

Columbus, Ohio 43215

United States

Site 57

Portland, Oregon 97210

United States

Site 60

Anderson, South Carolina 29621

United States

Site 95

Hermitage, Tennessee 37076

United States

Site 9

Knoxville, Tennessee 37909

United States

Site 4

Nashville, Tennessee 37215

United States

Site 76

Austin, Texas 78746

United States

Site 74

College Station, Texas 77845

United States

Site 67

Dallas, Texas 75230

United States

Site 14

Houston, Texas 77056

United States

Site 88

San Antonio, Texas 78218

United States

Site 91

Sugar Land, Texas 77479

United States

Site 19

South Jordan, Utah 84095

United States

Site 29

Forest, Virginia 24551

United States

Site 63

Norfolk, Virginia 23502

United States

Site 85

Norfolk, Virginia 23502

United States

Site 33

Burien, Washington 98168

United States

Site 70

Mill Creek, Washington 98012

United States