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Evaluating a new oral treatment for male pattern baldness

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

Phase 3 Interventional Veradermics, Inc. · NCT06972264

This study is testing a new oral medication for men with male pattern baldness to see if it can help them regrow hair.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment480 (estimated)
Ages18 Years to 65 Years
SexMale
SponsorVeradermics, Inc. Industry-sponsored
Drugs / interventionsradiation
Locations26 sites (Birmingham, Alabama and 25 other locations)
Trial IDNCT06972264 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the safety and efficacy of VDPHL01, an investigational oral medication, in male subjects diagnosed with Androgenetic Alopecia (AGA). The study is designed as a multi-center, double-blind trial lasting approximately 13 months, involving 11 scheduled visits for participants. Eligible males aged 18-65 with mild to moderate AGA will receive either the treatment or a placebo while adhering to specific hair care protocols throughout the study.

Who should consider this trial

Good fit: Ideal candidates are males aged 18-65 with a clinical diagnosis of mild to moderate AGA.

Not a fit: Patients with uncontrolled blood pressure or certain heart or thyroid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an effective oral option for men suffering from male pattern baldness.

How similar studies have performed: Other studies have explored treatments for AGA, but the specific approach of VDPHL01 is novel and has not been widely tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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.

Exclusion Criteria:

* 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

Where this trial is running

Birmingham, Alabama and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Androgenetic AlopeciaAGAMale Pattern BaldnessHair LossMale Hair Loss
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.