Efficacy and Safety of VDPHL01 in Males With AGA

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Androgenetic Alopecia, AGA, Male Pattern Baldness

In brief

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.

Key facts

Study ID: NCT06724614
Run by: Veradermics, Inc.
People needed: 480
Starts: 2024-11-06
Expected to finish: 2026-09-01
Last updated by the study team: 2025-11-06

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 it is running

Site 36 — Birmingham, Alabama, United States
Site 28 — Phoenix, Arizona, United States
Site 30 — Fort Smith, Arkansas, United States
Site 35 — Rogers, Arkansas, United States
Site 07 — Fountain Valley, California, United States
Site 02 — Fremont, California, United States
Site 34 — Sherman Oaks, California, United States
Site 21 — Vista, California, United States
Site 05 — Castle Rock, Colorado, United States
Site 24 — Englewood, Colorado, United States
Site 17 — Aventura, Florida, United States
Site 25 — Brandon, Florida, United States
Site 42 — Hollywood, Florida, United States
Site 03 — Tampa, Florida, United States
Site 43 — Atlanta, Georgia, United States
Site 31 — Boise, Idaho, United States
Site 23 — Rolling Meadows, Illinois, United States
Site 15 — Indianapolis, Indiana, United States
Site 32 — New Albany, Indiana, United States
Site 27 — West Lafayette, Indiana, United States
Site 41 — Baton Rouge, Louisiana, United States
Site 13 — Covington, Louisiana, United States
Site 12 — Metairie, Louisiana, United States
Site 22 — Brighton, Massachusetts, United States
Site 26 — Clarkston, Michigan, United States

Full record on ClinicalTrials.gov

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