TOKYO, Jan. 24, 2011 /PRNewswire/ — R-Tech Ueno, Ltd. is
pleased to announce that the Phase 2a clinical study of RK-023 to
treat androgenetic alopecia (note 1) was completed by January 21,
2011.
Our company focuses on the area of no topical prescription drug
in the market of androgenetic alopecia treatment and has developed
a new topical drug. The Phase 2a clinical study of RK-023 for
androgenetic alopecia treatment was performed in 48 patients with
mild-to-moderate androgenetic alopecia, adult males aged 44 or
less, to evaluate safety and pharmacokinetics, and efficacy.
RK-023 was applied repeatedly for 13 weeks.
This clinical study was a double-masked (Note 2), randomized and
placebo-controlled (Note 3) study under Good Clinical Practice
(GCP), and RK-023 was applied 2 mL each to a hair-thinning part of
scalp twice daily in the patients with androgenetic alopecia.
Laboratory tests, vital signs (blood pressure, pulse rate, body
temperature and respiratory rate) and electrocardiogram were
examined as the safety assessment. Concentrations of RK-023
and its main metabolite in plasma were determined as a
pharmacokinetic study. Dermatologic examination for the degree of
baldness, global photo assessment, subject self-assessment and
phototrichogram (Note 4) were examined as the efficacy
assessment.
Forty-eight patients (24 cases of the RK-023 group and 24 cases
of the placebo group) were enrolled in this study. There was no
severe adverse event. The frequency of mild adverse events was
equal in both groups. In pharmacokinetic study, the main metabolite
of RK-023 was slightly detected in plasma of only one patient. This
showed 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 (Note 4) from the baseline compared with the
placebo group.
The president of R-Tech Ueno, Yukihiko Mash
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