An Open-Label Multi-Dose Study to Evaluate the Safety and Efficacy of VDPHL01 in Male and Female Subjects with Androgenetic Alopecia
This study will evaluate the safety and efficacy of VDPHL01 in male and female subjects with Androgenetic Alopecia (AGA). AGA (or pattern of hair loss) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablets for males and VDPHL01 4.5 mg Tablets for females are an investigational oral drug to treat male and female pattern baldness. This multiple center, open-label, 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). Male subjects that meet the study eligibility criteria will be administered VDPHL01 once daily for 12 months. Female subjects that meet the study eligibility criteria will be administered VDPHL01 either once or twice daily for 12 months.
• 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.