Efficacy and Safety of VDPHL01 in Males With AGA

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
Male
Accepts 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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VDHPL01 BID 		VDPHL01 will be taken orally twice a day, once in the AM and once in the PM.
  • Drug: VDPHL01
    VDPHL01 Extended Release (ER) Tablet
Experimental
VDPHL01 QD and Placebo QD 		Placebo will be taken orally once a day in the AM or PM. VDPHL01 will be taken orally once a day in the AM or PM.
  • Drug: VDPHL01
    VDPHL01 Extended Release (ER) Tablet
Placebo Comparator
Placebo BID with treatment extension to VDPHL01 BID 		Placebo will be taken orally twice a day, once in the AM and once in the PM for the first 6 months of the study. After month 6, VDPHL01 will be taken orally twice a day, once in the AM and once in the PM.
  • Drug: Placebo
    Placebo
Placebo Comparator
Placebo BID with treatment extension to VDPHL01 QD and Placebo QD 		Placebo will be taken orally twice a day, once in the AM and once in the PM for the first 6 months of the study. After month 6, placebo will be taken orally once a day in the AM or PM. VDPHL01 will be taken orally once a day in the AM or PM.
  • Drug: Placebo
    Placebo

Recruiting Locations

More Details

NCT ID
NCT06724614
Status
Active, not recruiting
Sponsor
Veradermics, Inc.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center