An Open Label, Multi-center Clinical Trial of Topical 5% Minoxidil Solution for the Treatment of Male Androgenetic Alopecia (A Phase IV Study)

Background: Topical 5% minoxidil solution stimulates new hair growth and it helps stop the loss of hair on individuals with androgenetic alopecia (AGA). Objective: We wanted to assess the efficacy and safety of topical 5% minoxidil solution for treating Korean men with AGA. Methods: This was a 24-week, open label, clinical trial that was conducted at 14 university dermatologic centers nationwide throughout South Korea as a multicenter study of the Korean Hair Research Society. The eligible subjects for this study were 18- to 65 year-old men with androgenetic alopecia, as defined by the Norwood scale as type III vertex, IV and IVA. A total of 175 men (20∼62 years old) with AGA applied topical 5% minoxidil solution twice daily. Efficacy was evaluated by 1) the total hair count per 1 cm and 2) the mean hair diameter and 3) the patient assessment and 4) the investigator assessment of the change in scalp coverage and the benefit of treatment. Results: At week 24 as compared with baseline, there was a statistically significant increase in the total hair counts and the mean hair diameter (p＜.0001). Topical 5% minoxidil solution helped improve the investigator and patient assessments. The topical 5% minoxidil solution was well tolerated over a 24-week period. Conclusion: We believe that topical 5% minoxidil solution is a safe and effective drug for Korean men with AGA.