RECRUITING

Safety and Efficacy of VDPHL01 in Males With AGA

Description

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).

Conditions

Androgenetic AlopeciaAGAMale Pattern Baldness
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Related Conditions:

Androgenetic AlopeciaAGAMale Pattern Baldness

Study Overview

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Study Details

Study overview

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).

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-dose Study to Evaluate the Efficacy and Safety of VDPHL01 in Male Subjects With Androgenetic Alopecia

Safety and Efficacy of VDPHL01 in Males With AGA

Condition
Androgenetic Alopecia
Intervention / Treatment

-

Contacts and Locations

Birmingham

Site 73, Birmingham, Alabama, United States, 35209

Encino

Site 69, Encino, California, United States, 91436

Manhattan Beach

Site 64, Manhattan Beach, California, United States, 90266

Santa Monica

Site 66, Santa Monica, California, United States, 90404

Boca Raton

Site 71, Boca Raton, Florida, United States, 33486

Coral Gables

Site 86, Coral Gables, Florida, United States, 33134

Coral Gables

Site 62, Coral Gables, Florida, United States, 33146

Chicago

Site 61, Chicago, Illinois, United States, 60611

Clarksville

Site 53, Clarksville, Indiana, United States, 47129

Plainfield

Site 55, Plainfield, Indiana, United States, 46168

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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 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.
  • * 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 screening;
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Veradermics, Inc.,

Reid Waldman, M.D., STUDY_CHAIR, Veradermics, Inc.

Timothy Durso, M.D., STUDY_CHAIR, Veradermics, Inc.

Study Record Dates

2026-11