The purpose of this study is to evaluate the safety and efficacy of three doses of topical NEOSH101 applied once-daily (qd) for 16 weeks in men with thinning hair in the top and center of the scalp (Norwood/Hamilton grades III-IV androgenetic alopecia). Four equally sized treatment groups (35 men each) will receive either NEOSH101 0.5%, NEOSH101 1.0%, NEOSH101 2.0% or placebo. A 12-week observation period will follow the treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
bioskin Institute for Dermatological Research and Development GmbH
Hamburg, Germany
Hair density, hair growth rate, hair diameter as measured using the Trichoscan method
Time frame: 16 weeks application treatment period followed by 12 weeks observation period
Assessment score of dermal tolerability
Time frame: 16 weeks application treatment period followed by 12 weeks observation period
Physician's global assessment score
Time frame: 16 weeks application treatment period followed by 12 weeks observation period
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