Safety and Efficacy of VDPHL01 in Females With Androgenetic Alopecia (AGA)

Not required.

Inclusion criteria

• Subject is a female 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 and can read, understand, and complete the 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 baseline;
• 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