Safety and Efficacy of VDPHL01 in Males and Females With AGA

Inclusion criteria

• Subject is male or non-pregnant female 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 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;
• Subject has symptoms or history of certain heart or thyroid conditions;
• Subject has a history of cardiac and/or thyroid diseases;
• Subject has received an organ transplant;
• Subject has a history of prescription drug abuse or illicit drug use within 6 months of screening; history of alcohol abuse within 6 months prior to screening;
• Subject has a current or recent history of dietary or weight changes;
• Subject has been diagnosed with COVID-19 within 16 weeks of baseline;
• Subject has used any topical scalp treatments for hair growth within 4 weeks prior to screening;
• Subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, etc. within 6 months prior to screening;
• Subject has had previous radiation of the scalp;
• Subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12 weeks prior to screening;
• Subject has used systemic beta blockers within 12 weeks prior to screening;
• Subject is currently enrolled in an investigational drug, biologic, or device study or has used an investigational treatment within 30 days 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.