Androgenetic Alopecia Clinical Trial
Official title:
Minoxidil Response Testing in Males With Androgenetic Alopecia
Topical minoxidil is the most common drug used for the treatment of AGA in men. While topical
minoxidil exhibits a good safety profile, the efficacy in the overall population remains
relatively low i.e., 30-40% re-grow hair. To observe significant improvement in hair growth,
minoxidil is typically used twice daily for a period of at least 16 weeks. Due to the
significant time commitment and low response rate, a diagnostic test to identify
non-responders prior to initiating therapy would be advantageous.
Minoxidil is converted in the scalp to its active form, minoxidil sulfate, by the
sulfotransferase enzyme SULT1A1. The enzyme expression is variable among individuals. We have
demonstrated in two prior feasibility studies that the SULT1A1 enzyme activity in plucked
hair follicles correlates with minoxidil response in the treatment of AGA and thus can server
as a predictive biomarker.
Consequently, we developed a minoxidil response in-vitro diagnostic kit intended to identify
non-responders prior to initiating therapy with 5% topical minoxidil foam.
The primary purpose of this study is to evaluate the clinical validity of the minoxidil
response in-vitro diagnostic kit.
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