January 31, 2011
R-Tech Ueno reported results from a phase IIa trial of RK-023 for the treatment of alopecia. The double blind, placebo-controlled study enrolled 48 adult males (aged 44 years and younger) with mild-to-moderate androgenetic alopecia. The subjects trial applied RK-023 2 mL each to a hair-thinning part of scalp twice daily for 13 consecutive weeks. Endpoints included safety, pharmacokinetics and pharnacodynamics and the presence of anagen hair, defined as hair with a growth rate of 0.2 mm or more per day through phototrichogram. There were no reports of serious adverse events. Adverse events were similar between the RK-023 and placebo treatment arms. The main metabolite of RK-023 was slightly detected in plasma of only one subject, showing that the transdermal absorption of RK-023 from the scalp was low. In the efficacy assessment, the RK-023 group showed possibility of improvement in global photo assessment and in numbers of anagen hair from the baseline compared with the placebo group.