Trials Today

Efficacy and Safety of VDPHL01 in Males with AGA

Purpose

This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA). AGA (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablet is an investigational oral drug to treat male pattern baldness. 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). The first 7 visits will be part of the placebo-controlled period. The next 3 visits will be part of the treatment extension phase. All subjects will receive active drug in the treatment extension phase.

Conditions

Androgenetic Alopecia
AGA
Male Pattern Baldness

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Genders: Male
Accepts Healthy Volunteers: No

Inclusion Criteria

Subject is male aged 18-65 years old; - Subject has a clinical diagnosis of mild to moderate AGA; - Subject is in good general health and has normal 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 read, understand, and complete 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; - Subject has symptoms or history of certain heart or thyroid conditions; - Subject has a history of cardiac and/or thyroid diseases; - Subject has received an organ transplant; - Subject has a history of prescription drug abuse or illicit drug use within 6 months of screening; history of alcohol abuse within 6 months prior to screening; - Subject has a current or recent history of dietary or weight changes; - Subject has been diagnosed with COVID-19 within 16 weeks of baseline; - Subject has used any topical scalp treatments for hair growth within 4 weeks prior to screening; - Subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, etc. within 6 months prior to screening - Subject has had previous radiation of the scalp - Subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12 weeks prior to screening - Subject has used systemic beta blockers within 12 weeks prior to screening - Subject is currently enrolled in an investigational drug, biologic, or device study or has used an investigational treatment within 30 days 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

Study Design

Phase: Phase 2/Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental VDHPL01 BID	VDPHL01 will be taken orally twice a day, once in the AM and once in the PM.	Drug: VDPHL01 VDPHL01 Extended Release (ER) Tablet
Experimental VDPHL01 QD and Placebo QD	Placebo will be taken orally once a day in the AM. VDPHL01 will be taken orally once a day in the PM.	Drug: VDPHL01 VDPHL01 Extended Release (ER) Tablet
Placebo Comparator Placebo BID with treatment extension to VDPHL01 BID	Placebo will be taken orally twice a day, once in the AM and once in the PM for the first 6 months of the study. After month 6, VDPHL01 will be taken orally twice a day, once in the AM and once in the PM.	Drug: Placebo Placebo
Placebo Comparator Placebo BID with treatment extension to VDPHL01 QD and Placebo QD	Placebo will be taken orally twice a day, once in the AM and once in the PM for the first 6 months of the study. After month 6, placebo will be taken orally once a day in the AM. VDPHL01 will be taken orally once a day in the PM.	Drug: Placebo Placebo

Recruiting Locations

Site 36
Birmingham, Alabama 35203

Site 28
Phoenix, Arizona 85018

Site 30
Fort Smith, Arkansas 72916

Site 35
Rogers, Arkansas 72758

Site 07
Fountain Valley, California 92728

Site 02
Fremont, California 94538

Site 34
Sherman Oaks, California 91403

Site 21
Vista, California 92083

Site 05
Castle Rock, Colorado 80109

Site 24
Englewood, Colorado 80111

Site 17
Aventura, Florida 33180

Site 25
Brandon, Florida 33511

Site 42
Hollywood, Florida 33021

Site 03
Tampa, Florida 33613

Site 43
Atlanta, Georgia 30329

Site 31
Boise, Idaho 83704

Site 23
Rolling Meadows, Illinois 60008

Site 15
Indianapolis, Indiana 46250

Site 32
New Albany, Indiana 47150

Site 27
West Lafayette, Indiana 47906

Site 41
Baton Rouge, Louisiana 70809

Site 13
Covington, Louisiana 70433

Site 12
Metairie, Louisiana 70006

Site 22
Brighton, Massachusetts 02135

Site 26
Clarkston, Michigan 48346

Site 06
New Brighton, Minnesota 55112

Site 18
Hackensack, New Jersey 07601

Site 37
Kew Gardens, New York 11415

Site 38
New York, New York 10075

Site 39
Boardman, Ohio 44512

Site 11
Columbus, Ohio 43215

Site 08
Broomall, Pennsylvania 19073

Site 10
Plymouth Meeting, Pennsylvania 19462

Site 20
Greensville, South Carolina 29615

Site 09
Knoxville, Tennessee 37909

Site 16
Murfreesboro, Tennessee 37130

Site 04
Nashville, Tennessee 37215

Site 40
Bellaire, Texas 77401

Site 44
Dallas, Texas 75231

Site 14
Houston, Texas 77056

Site 19
West Jordan, Utah 84095

Site 29
Lynchburg, Virginia 24501

Site 33
Seattle, Washington 98168

Site 01
Spokane, Washington 99202

More Details

NCT ID: NCT06724614
Status: Recruiting
Sponsor: Veradermics, Inc.

Study Contact

Katie Mateja, MBA
858-571-1800
clinicalresearch@therapeuticsinc.com