CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 800 enrolled
Drug / intervention
GSK2585823(CLDM 1%-BPO 3% gel) +1 moredrug
Likely dose
GSK2585823(CLDM 1%-BPO 3% gel) 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/NCT01445301
NCT01445301Phase 3Completed
CompareCT.gov

Study STF115287, a Clinical Confirmation Study of GSK2585823 (Clindamycin 1%-Benzoyl Peroxide 3% Gel) in the Treatment of Acne Vulgaris in Japanese Subjects. - A Multicenter, Randomized, Single-blind, Active-controlled, Parallel-group Study -

GlaxoSmithKline·interventional·Posted Oct 3, 2011·Updated Apr 27, 2018

In Brief

A Phase 3 clinical trial evaluating GSK2585823(CLDM 1%-BPO 3% gel) and CLDM 1% gel twice daily for Acne Vulgaris. Completed, enrolled 800 participants across 26 sites.

Detailed Summary

This is a multicenter, randomized, single-blinded (investigator's blinded), active-controlled (clindamycin \[CLDM\] 1% gel), parallel-group study in Japanese subjects with acne vulgaris to demonstrate the efficacy of GSK2585823 (CLDM 1%-benzoyl peroxide \[BPO\] 3% gel) when applied once or twice daily for 12 weeks. This study will also evaluate the safety of GSK2585823 when applied topically either once or twice daily for 12 weeks.

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 3, 2011
Enrollment StartSep 27, 2011
Primary CompletionAug 2, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.7 years ago

Interventions

GSK2585823(CLDM 1%-BPO 3% gel)drug

Topical gel in 1 g containing clindamycin 10 mg and benzoyl peroxide 30 mg

CLDM 1% gel twice dailydrug

Topical gel containing clindamycin 10 mg/1 g gel