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RECRUITING

NCT07146022

PHASE3

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

Sponsor: Veradermics, Inc.

View on ClinicalTrials.gov

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).

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Dose Study to Evaluate the Efficacy and Safety of VDPHL01 in Female Subjects With Androgenetic Alopecia

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

552

Start Date

2025-07-25

Completion Date

2028-01

Last Updated

2025-11-24

Healthy Volunteers

Conditions

Androgenetic Alopecia (AGA)Androgenetic Alopecia AGA Female Androgenetic Alopecia Hair Loss

Interventions

DRUG

VDPHL01 QD

VDPHL01 Extended Release (ER) Tablet

DRUG

Placebo

Placebo tablet

DRUG

VDPHL01 BID

VDPHL01 Extended Release (ER) Tablet

DRUG

Placebo

Placebo tablet

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

Locations (71)

Site 73

Birmingham, Alabama, United States

Site 89

Birmingham, Alabama, United States

Site 77

Phoenix, Arizona, United States

Site 30

Fort Smith, Arkansas, United States

Site 69

Encino, California, United States

Site 2

Fremont, California, United States

Site 64

Manhattan Beach, California, United States

Site 93

Northridge, California, United States

Site 66

Santa Monica, California, United States

Site 34

Sherman Oaks, California, United States

Site 94

Thousand Oaks, California, United States

Site 21

Vista, California, United States

Site 5

Castle Rock, Colorado, United States

Site 24

Greenwood Village, Colorado, United States

Site 17

Aventura, Florida, United States

Site 71

Boca Raton, Florida, United States

Site 86

Coral Gables, Florida, United States

Site 62

Coral Gables, Florida, United States

Site 99

Miami, Florida, United States

Site 54

Ocala, Florida, United States

Site 43

Atlanta, Georgia, United States

Site 90

Sandy Springs, Georgia, United States

Site 31

Boise, Idaho, United States

Site 61

Chicago, Illinois, United States

Site 53

Clarksville, Indiana, United States

Site 15

Indianapolis, Indiana, United States

Site 32

New Albany, Indiana, United States

Site 55

Plainfield, Indiana, United States

Site 27

West Lafayette, Indiana, United States

Site 79

Leawood, Kansas, United States

Site 52

Louisville, Kentucky, United States

Site 41

Baton Rouge, Louisiana, United States

Site 13

Covington, Louisiana, United States

Site 12

Metairie, Louisiana, United States

Site 75

New Orleans, Louisiana, United States

Site 84

Glenn Dale, Maryland, United States

Site 87

Rockville, Maryland, United States

Site 22

Brighton, Massachusetts, United States

Site 80

Chestnut Hill, Massachusetts, United States

Site 59

Quincy, Massachusetts, United States

Site 26

Clarkston, Michigan, United States

Site 68

Clinton Township, Michigan, United States

Site 83

Southfield, Michigan, United States

Site 98

Medina, Minnesota, United States

Site 56

Minneapolis, Minnesota, United States

Site 6

New Brighton, Minnesota, United States

Site 18

Hackensack, New Jersey, United States

Site 37

Kew Gardens, New York, United States

Site 97

New York, New York, United States

Site 82

Hickory, North Carolina, United States

Site 92

Huntersville, North Carolina, United States

Site 39

Boardman, Ohio, United States

Site 72

Cincinnati, Ohio, United States

Site 11

Columbus, Ohio, United States

Site 57

Portland, Oregon, United States

Site 60

Anderson, South Carolina, United States

Site 95

Hermitage, Tennessee, United States

Site 9

Knoxville, Tennessee, United States

Site 4

Nashville, Tennessee, United States

Site 76

Austin, Texas, United States

Site 74

College Station, Texas, United States

Site 67

Dallas, Texas, United States

Site 14

Houston, Texas, United States

Site 88

San Antonio, Texas, United States

Site 91

Sugar Land, Texas, United States

Site 19

South Jordan, Utah, United States

Site 29

Forest, Virginia, United States

Site 63

Norfolk, Virginia, United States

Site 85

Norfolk, Virginia, United States

Site 33

Burien, Washington, United States

Site 70

Mill Creek, Washington, United States

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (71)