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

Status: Recruiting
Location: See all (66) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Site 73
RECRUITING
Birmingham
Site 89
RECRUITING
Birmingham
Arkansas
Site 30
RECRUITING
Fort Smith
Arizona
Site 77
RECRUITING
Phoenix
California
Site 69
RECRUITING
Encino
Site 2
RECRUITING
Fremont
Site 64
RECRUITING
Manhattan Beach
Site 93
RECRUITING
Northridge
Site 66
RECRUITING
Santa Monica
Site 34
RECRUITING
Sherman Oaks
Site 94
RECRUITING
Thousand Oaks
Site 21
RECRUITING
Vista
Colorado
Site 5
RECRUITING
Castle Rock
Site 24
RECRUITING
Greenwood Village
Florida
Site 17
RECRUITING
Aventura
Site 71
RECRUITING
Boca Raton
Site 62
RECRUITING
Coral Gables
Site 86
RECRUITING
Coral Gables
Site 99
RECRUITING
Miami
Site 54
RECRUITING
Ocala
Georgia
Site 43
RECRUITING
Atlanta
Site 90
RECRUITING
Sandy Springs
Idaho
Site 31
RECRUITING
Boise
Indiana
Site 53
RECRUITING
Clarksville
Site 15
RECRUITING
Indianapolis
Site 32
RECRUITING
New Albany
Site 55
RECRUITING
Plainfield
Site 27
RECRUITING
West Lafayette
Kansas
Site 79
RECRUITING
Leawood
Kentucky
Site 52
RECRUITING
Louisville
Louisiana
Site 41
RECRUITING
Baton Rouge
Site 13
RECRUITING
Covington
Site 12
RECRUITING
Metairie
Site 75
RECRUITING
New Orleans
Massachusetts
Site 22
RECRUITING
Brighton
Site 80
RECRUITING
Chestnut Hill
Site 59
RECRUITING
Quincy
Maryland
Site 84
RECRUITING
Glenn Dale
Site 87
RECRUITING
Rockville
Michigan
Site 26
RECRUITING
Clarkston
Site 68
RECRUITING
Clinton Township
Minnesota
Site 56
NOT_YET_RECRUITING
Minneapolis
Site 6
RECRUITING
New Brighton
North Carolina
Site 82
RECRUITING
Hickory
Site 92
RECRUITING
Huntersville
New Jersey
Site 18
RECRUITING
Hackensack
New York
Site 37
RECRUITING
Kew Gardens
Ohio
Site 39
RECRUITING
Boardman
Site 72
RECRUITING
Cincinnati
Site 11
RECRUITING
Columbus
Oregon
Site 57
RECRUITING
Portland
South Carolina
Site 60
RECRUITING
Anderson
Tennessee
Site 95
RECRUITING
Hermitage
Site 9
RECRUITING
Knoxville
Site 4
RECRUITING
Nashville
Texas
Site 76
RECRUITING
Austin
Site 74
RECRUITING
College Station
Site 14
TERMINATED
Houston
Site 88
RECRUITING
San Antonio
Site 91
RECRUITING
Sugar Land
Utah
Site 19
RECRUITING
South Jordan
Virginia
Site 29
RECRUITING
Forest
Site 63
RECRUITING
Norfolk
Site 85
RECRUITING
Norfolk
Washington
Site 33
RECRUITING
Burien
Site 70
RECRUITING
Mill Creek
Contact Information
Primary
AGA Study Manager
clinicalresearch@therapeuticsinc.com
858-571-1800
Time Frame
Start Date: 2025-07-25
Estimated Completion Date: 2027-03
Participants
Target number of participants: 552
Treatments
Experimental: VDPHL01 BID
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.
Experimental: VDPHL01 QD and Placebo QD
Placebo will be taken orally once a day (QD) in the AM and VDPHL01 will be taken orally once a day (QD) in the PM for the first 6 months of the study. After month 6, subject will continue this same dose regimen for an additional 6 months.
Placebo_comparator: Placebo BID with treatment extension to VDPHL01 BID
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.
Placebo_comparator: Placebo BID with treatment extension to VDPHL01 QD and Placebo QD
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; VDPHL01 will be taken orally once a day in the PM for an additional 6 months.
Related Therapeutic Areas
Sponsors
Leads: Veradermics, Inc.

This content was sourced from clinicaltrials.gov