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

NCT07146022 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 250-13951-306
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 71

Brief 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).

Conditions

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

Keywords

Androgenetic Alopecia; AGA; Hair Loss

Outcome Measures

Primary Outcomes (2)

• Changes in non-vellus Target Area Hair Counts (TAHC)

  Changes from baseline in non-vellus TAHC using digital image analysis at Month 6.

  Month 6

• 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

Study Arms (4)

VDPHL01 BID

EXPERIMENTAL

VDPHL01 will be taken orally twice a day (BID), once in the AM and once in the PM for the first 6 months of the study. After month 6, subject will continue VDPHL01 BID for an additional 6 months.

Drug: VDPHL01 BID

VDPHL01 QD and Placebo QD

EXPERIMENTAL

Placebo will be taken orally once a day (QD) in the AM or PM. VDPHL01 will be taken orally once a day (QD) in the AM or PM for the first 6 months of the study. After month 6, subject will continue this same dose regimen for an additional 6 months.

Drug: VDPHL01 QD; Drug: Placebo

Placebo BID with treatment extension to VDPHL01 BID

PLACEBO COMPARATOR

Placebo will be taken orally twice a day (BID), once in the AM and once in the PM for the first 6 months of the study. After month 6, subject will switch to VDPHL01 BID group, and take VDPHL01 orally twice a day (BID), once in the AM and once in the PM for an additional 6 months.

Drug: Placebo

Placebo BID with treatment extension to VDPHL01 QD and Placebo QD

PLACEBO COMPARATOR

Placebo will be taken orally twice a day (BID), once in the AM and once in the PM for the first 6 months of the study. After month 6, subject will switch to VDPHL01 QD and Placebo QD group, and take placebo orally once a day in the AM or PM; VDPHL01 will be taken orally once a day in the AM or PM for an additional 6 months.

Drug: Placebo

Interventions

VDPHL01 QD DRUG

VDPHL01 Extended Release (ER) Tablet

VDPHL01 QD and Placebo QD

Placebo DRUG

Placebo tablet

Placebo BID with treatment extension to VDPHL01 BID; Placebo BID with treatment extension to VDPHL01 QD and Placebo QD; VDPHL01 QD and Placebo QD

VDPHL01 BID DRUG

VDPHL01 Extended Release (ER) Tablet

VDPHL01 BID

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Veradermics, Inc.: lead

Study Sites (71)

Site 73

Birmingham, Alabama, 35209, United States

RECRUITING

Site 89

Birmingham, Alabama, 35244, United States

RECRUITING

Site 77

Phoenix, Arizona, 85006, United States

RECRUITING

Site 30

Fort Smith, Arkansas, 72916, United States

RECRUITING

Site 69

Encino, California, 91436, United States

RECRUITING

Site 2

Fremont, California, 94538, United States

RECRUITING

Site 64

Manhattan Beach, California, 90266, United States

RECRUITING

Site 93

Northridge, California, 91324, United States

RECRUITING

Site 66

Santa Monica, California, 90404, United States

RECRUITING

Site 34

Sherman Oaks, California, 91403, United States

RECRUITING

Site 94

Thousand Oaks, California, 91320, United States

RECRUITING

Site 21

Vista, California, 92083, United States

RECRUITING

Site 5

Castle Rock, Colorado, 80109, United States

RECRUITING

Site 24

Greenwood Village, Colorado, 80111, United States

RECRUITING

Site 17

Aventura, Florida, 33180, United States

RECRUITING

Site 71

Boca Raton, Florida, 33486, United States

RECRUITING

Site 86

Coral Gables, Florida, 33134, United States

RECRUITING

Site 62

Coral Gables, Florida, 33146, United States

RECRUITING

Site 99

Miami, Florida, 33173, United States

RECRUITING

Site 54

Ocala, Florida, 34470, United States

RECRUITING

Site 43

Atlanta, Georgia, 30329, United States

RECRUITING

Site 90

Sandy Springs, Georgia, 30328, United States

RECRUITING

Site 31

Boise, Idaho, 83704, United States

RECRUITING

Site 61

Chicago, Illinois, 60610, United States

NOT YET RECRUITING

Site 53

Clarksville, Indiana, 47129, United States

RECRUITING

Site 15

Indianapolis, Indiana, 46250, United States

RECRUITING

Site 32

New Albany, Indiana, 47150, United States

RECRUITING

Site 55

Plainfield, Indiana, 46168, United States

RECRUITING

Site 27

West Lafayette, Indiana, 47906, United States

RECRUITING

Site 79

Leawood, Kansas, 66211, United States

RECRUITING

Site 52

Louisville, Kentucky, 40241, United States

RECRUITING

Site 41

Baton Rouge, Louisiana, 70809, United States

RECRUITING

Site 13

Covington, Louisiana, 70433, United States

RECRUITING

Site 12

Metairie, Louisiana, 70006, United States

RECRUITING

Site 75

New Orleans, Louisiana, 70124, United States

RECRUITING

Site 84

Glenn Dale, Maryland, 20769, United States

RECRUITING

Site 87

Rockville, Maryland, 20850, United States

RECRUITING

Site 22

Brighton, Massachusetts, 02135, United States

RECRUITING

Site 80

Chestnut Hill, Massachusetts, 02467, United States

RECRUITING

Site 59

Quincy, Massachusetts, 02169, United States

RECRUITING

Site 26

Clarkston, Michigan, 48346, United States

RECRUITING

Site 68

Clinton Township, Michigan, 48038, United States

RECRUITING

Site 83

Southfield, Michigan, 48034, United States

NOT YET RECRUITING

Site 98

Medina, Minnesota, 55340, United States

NOT YET RECRUITING

Site 56

Minneapolis, Minnesota, 55455, United States

RECRUITING

Site 6

New Brighton, Minnesota, 55112, United States

RECRUITING

Site 18

Hackensack, New Jersey, 07601, United States

RECRUITING

Site 37

Kew Gardens, New York, 11415, United States

RECRUITING

Site 97

New York, New York, 10003, United States

NOT YET RECRUITING

Site 82

Hickory, North Carolina, 28602, United States

RECRUITING

Site 92

Huntersville, North Carolina, 28078, United States

RECRUITING

Site 39

Boardman, Ohio, 44512, United States

RECRUITING

Site 72

Cincinnati, Ohio, 45236, United States

RECRUITING

Site 11

Columbus, Ohio, 43215, United States

RECRUITING

Site 57

Portland, Oregon, 97210, United States

RECRUITING

Site 60

Anderson, South Carolina, 29621, United States

RECRUITING

Site 95

Hermitage, Tennessee, 37076, United States

RECRUITING

Site 9

Knoxville, Tennessee, 37909, United States

RECRUITING

Site 4

Nashville, Tennessee, 37215, United States

RECRUITING

Site 76

Austin, Texas, 78746, United States

RECRUITING

Site 74

College Station, Texas, 77845, United States

RECRUITING

Site 67

Dallas, Texas, 75230, United States

NOT YET RECRUITING

Site 14

Houston, Texas, 77056, United States

TERMINATED

Site 88

San Antonio, Texas, 78218, United States

RECRUITING

Site 91

Sugar Land, Texas, 77479, United States

RECRUITING

Site 19

South Jordan, Utah, 84095, United States

RECRUITING

Site 29

Forest, Virginia, 24551, United States

RECRUITING

Site 63

Norfolk, Virginia, 23502, United States

RECRUITING

Site 85

Norfolk, Virginia, 23502, United States

RECRUITING

Site 33

Burien, Washington, 98168, United States

RECRUITING

Site 70

Mill Creek, Washington, 98012, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Reid Waldman, M.D.

  Veradermics, Inc.

  STUDY CHAIR

• Timothy Durso, M.D.

  Veradermics, Inc.

  STUDY CHAIR

Central Study Contacts

AGA Study Manager

CONTACT

858-571-1800; clinicalresearch@therapeuticsinc.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 28, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (71)