CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 360 enrolled
Drug / intervention
GI148512 +1 moredrug
Likely dose
GI148512 1 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01400932
NCT01400932Phase 3Completed
CompareCT.gov

Study STF115288, a Clinical Confirmation Study of GI148512 (Benzoyl Peroxide 3% Gel) in the Treatment of Acne Vulgaris in Japanese Subjects.- A Multicenter, Randomized, Double-blinded, Vehicle-controlled, Parallel-group Study -

GlaxoSmithKline·interventional·Posted Jul 25, 2011·Updated Aug 5, 2014

In Brief

A Phase 3 clinical trial evaluating GI148512 and vehicle gel for Acne Vulgaris. Completed, enrolled 360 participants across 19 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 25, 2011
Enrollment StartJul 1, 2011
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.9 years ago

Interventions

GI148512drug

GI148512, Topical gel in 1 g containing benzoyl peroxide 30 mg

vehicle geldrug

Matching vehicle gel of GI148512, not containing active ingredient (benzoyl peroxide)