drugset / Trial / NCT01769664

A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris

NCT01769664

Phase 1 Completed 650 enrolled Sun Pharmaceutical Industries, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this study is to compare the relative efficacy and safety of the test formulation Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to the marketed formulation Duac® Topical Gel (Clindamycin 1%/Benzoyl Peroxide 5%) (Stiefel) in the treatment of the inflamed lesions of acne vulgaris. Both the test and reference formulations will also be compared to a placebo formulation to test for superiority.

Timeline

Start
2012-09
Primary completion
2013-06
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Benzoyl Peroxide Other / unclassified 5 % Topical
Subject Clindamycin Unknown 1 % Topical

Indications