Efficacy and Safety 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). 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

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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). 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.

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

Efficacy and Safety of VDPHL01 in Males with AGA

Condition
Androgenetic Alopecia
Intervention / Treatment

-

Contacts and Locations

Birmingham

Site 36, Birmingham, Alabama, United States, 35203

Fort Smith

Site 30, Fort Smith, Arkansas, United States, 72916

Rogers

Site 35, Rogers, Arkansas, United States, 72758

Fremont

Site 02, Fremont, California, United States, 94538

Sherman Oaks

Site 34, Sherman Oaks, California, United States, 91403

Vista

Site 21, Vista, California, United States, 92083

Castle Rock

Site 05, Castle Rock, Colorado, United States, 80109

Aventura

Site 17, Aventura, Florida, United States, 33180

Hollywood

Site 42, Hollywood, Florida, United States, 33021

Atlanta

Site 43, Atlanta, Georgia, United States, 30329

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 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.
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Veradermics, Inc.,

Study Record Dates

2026-07