Japanese Phase 1 Study of GSK2585823

Summary

This is a randomized, single-center, partial-blind study to evaluate the dermal irritation potential and to detect photo-toxicity and photo-allergy potential of GSK2585823, Benzoyl peroxide BPO 5% gel, Benzoyl peroxide 3% gel, vehicle gel and negative control (distilled water) applied using Finn-Chambers® by single and 7-day repeat patch test in 20 Japanese healthy male and female volunteers. Finn-Chambers containing no investigational product will be applied in the same manner. Safety will also be assessed by measurement of vital signs, electrocardiograms, safety laboratory data and review of adverse events.

Timeline

Start

2010-11-18

Primary completion

2011-02-15

Completion

2011-02-15

Publications

• Background Nakahara N, Nohda S, Hirama T. Dermal safety of GSK2585823 in healty Japanese subjects. [J Clin Therapeut Med]. 2012;(September):867-876.

Drugs

Indications