Study STF115288, a Clinical Confirmation Study of GI148512 in the Treatment of Acne Vulgaris in Japanese Subjects

Summary

This is a multicenter, randomized, double-blinded, vehicle-controlled, parallel-group study in Japanese subjects with acne vulgaris to demonstrate the efficacy of GI148512 (benzoyl peroxide \[BPO\] 3% gel) when applied once daily for 12 weeks. This study will also evaluate the safety of GI148512 when applied topically once daily for 12 weeks.

Timeline

Start

2011-07

Primary completion

2012-04

Completion

2012-04

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN GI148512: -42.9 (Standard Error 1.93) Lesion counts NCT01400932 ↗

registry analysis (superiority or other test); GI148512 vs Vehicle Gel; p <0.001; Mean Difference (Net) -21.0 (95% CI -26.2 to -15.8); ANCOVA NCT01400932 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GI148512	Unknown	30 mg	Topical

Indications