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Clinical Trials in the USA / NCT06724614
Active, not recruiting Phase 2/3

Efficacy and Safety of VDPHL01 in Males With AGA

NCT06724614 · tracked via the Priya Life Science USA tracker
Sponsor
Veradermics, Inc.
Phase
Phase 2/3
Started
2024-11-06
Last updated
2025-11-06

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).

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.

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 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. 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 36 Birmingham Alabama
Site 28 Phoenix Arizona
Site 30 Fort Smith Arkansas
Site 35 Rogers Arkansas
Site 07 Fountain Valley California
Site 02 Fremont California
Site 34 Sherman Oaks California
Site 21 Vista California
Site 05 Castle Rock Colorado
Site 24 Englewood Colorado
Site 17 Aventura Florida
Site 25 Brandon Florida
Site 42 Hollywood Florida
Site 03 Tampa Florida
Site 43 Atlanta Georgia
Site 31 Boise Idaho
Site 23 Rolling Meadows Illinois
Site 15 Indianapolis Indiana
Site 32 New Albany Indiana
Site 27 West Lafayette Indiana
Site 41 Baton Rouge Louisiana
Site 13 Covington Louisiana
Site 12 Metairie Louisiana
Site 22 Brighton Massachusetts
Site 26 Clarkston Michigan
Site 06 New Brighton Minnesota
Site 18 Hackensack New Jersey
Site 37 Kew Gardens New York
Site 38 New York New York
Site 39 Boardman Ohio
Site 11 Columbus Ohio
Site 08 Broomall Pennsylvania
Site 10 Plymouth Meeting Pennsylvania
Site 20 Greensville South Carolina
Site 09 Knoxville Tennessee
Site 16 Murfreesboro Tennessee
Site 04 Nashville Tennessee
Site 40 Bellaire Texas
Site 44 Dallas Texas
Site 14 Houston 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 NCT06724614 on ClinicalTrials.gov ↗ ← All trials in the USA