Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

A Phase 2 Multicenter, Randomized, Placebo- and Comparator-Controlled, Double-Blind Parallel Group Study to Evaluate the Safety and Efficacy of Topical NEOSH101 in the Treatment of Androgenetic Alopecia in Men

The purpose of this study is to measure the hair growth response to topical NEOSH101 when applied twice daily to the balding scalp for 16 weeks. One hundred eighty men with Norwood/Hamilton grades III-IV with thinning in the top and center of the scalp will participate. Three equally sized treatment groups (60 men each) will receive either topical NEOSH101 2.0%, minoxidil 5%, or placebo.

Inclusion Criteria:

• Caucasian men, in general good health, aged 18-49 years
• Norwood/Hamilton grades III-IV, with thinning hair in the vertex area

Exclusion Criteria:

• concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
• treatment with a systemic or locally acting medication which may interfere with the study objectives, such as minoxidil treatment in the 6 months prior to study start, finasteride treatment in the 12 months prior to study start, or treatment with other investigational hair growth products in the 6 months prior to study start