Status:
RECRUITING
Safety and Efficacy of VDPHL01 in Males With AGA
Lead Sponsor:
Veradermics, Inc.
Conditions:
Androgenetic Alopecia
AGA
Eligibility:
MALE
18-65 years
Phase:
PHASE3
Brief 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) h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT06972264
Start Date
March 11 2025
End Date
July 1 2027
Last Update
November 6 2025
Active Locations (44)
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1
Site 73
Birmingham, Alabama, United States, 35209
2
Site 89
Birmingham, Alabama, United States, 35244
3
Site 77
Phoenix, Arizona, United States, 85006
4
Site 69
Encino, California, United States, 91436