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Clinical Trials in the USA / NCT06972264
Active, not recruiting Phase 3

Safety and Efficacy of VDPHL01 in Males With AGA

NCT06972264 · tracked via the Priya Life Science USA tracker
Sponsor
Veradermics, Inc.
Phase
Phase 3
Started
2025-03-11
Last updated
2026-02-12

Condition(s) studied

Androgenetic AlopeciaAGAMale Pattern Baldness

Investigational drug(s) / intervention(s)

VDPHL01Placebo

VDPHL01: VDPHL01 Extended Release (ER) Tablet

Placebo: Placebo

Study summary

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).

Eligibility

Sex
MALE
Min age
18 Years
Max age
65 Years
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 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

Primary outcome measure(s)

Trial sites (44)

FacilityCityRegionStatus
Site 73 Birmingham Alabama
Site 89 Birmingham Alabama
Site 77 Phoenix Arizona
Site 69 Encino California
Site 64 Manhattan Beach California
Site 93 Northridge California
Site 66 Santa Monica California
Site 94 Thousand Oaks California
Site 71 Boca Raton Florida
Site 86 Coral Gables Florida
Site 62 Coral Gables Florida
Site 99 Miami Florida
Site 54 Ocala Florida
Site 96 Tamarac Florida
Site 90 Sandy Springs Georgia
Site 61 Chicago Illinois
Site 53 Clarksville Indiana
Site 55 Plainfield Indiana
Site 79 Leawood Kansas
Site 52 Louisville Kentucky
Site 75 New Orleans Louisiana
Site 84 Glenn Dale Maryland
Site 87 Rockville Maryland
Site 80 Chestnut Hill Massachusetts
Site 59 Quincy Massachusetts
Site 68 Clinton Township Michigan
Site 83 Troy Michigan
Site 82 Hickory North Carolina
Site 92 Huntersville North Carolina
Site 72 Cincinnati Ohio
Site 57 Portland Oregon
Site 81 East Greenwich Rhode Island
Site 60 Anderson South Carolina
Site 95 Hermitage Tennessee
Site 76 Austin Texas
Site 51 Austin Texas
Site 74 College Station Texas
Site 67 Dallas Texas
Site 78 Plano Texas
Site 88 San Antonio Texas

+ 4 more sites — see the full list on the official registry below.

More Veradermics, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06972264 on ClinicalTrials.gov ↗ ← All trials in the USA