Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

Phase 3 Completed 1315 enrolled Stiefel, a GSK Company GlaxoSmithKline · collab Quintiles, Inc. · collab Rho, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris

Timeline

Start: 2008-10
Primary completion: 2009-09
Completion: 2009-09

Outcome

Mixed primary results

registry MEAN Duac Low-dose (LD) Gel: -24.8 (Standard Deviation 20.1) lesion counts NCT00776919 ↗

registry MEAN BPO Gel: -22.2 (Standard Deviation 17.6) lesion counts NCT00776919 ↗

registry analysis (superiority or other test); Duac Low-dose (LD) Gel vs BPO Gel; p = 0.102; ANCOVA NCT00776919 ↗

registry analysis (superiority or other test); Duac Low-dose (LD) Gel vs BPO Gel; p = 0.015; ANCOVA NCT00776919 ↗

Publications

Background Eichenfield LF, Alio Saenz AB. Safety and efficacy of clindamycin phosphate 1.2%-benzoyl peroxide 3% fixed-dose combination gel for the treatment of acne vulgaris: a phase 3, multicenter, randomized, double-blind, active- and vehicle-controlled study. J Drugs Dermatol. 2011 Dec;10(12):1382-96.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Benzoyl Peroxide	Other / unclassified	—	Topical
Comparator	Clindamycin	Unknown	—	Topical