NCT01769664

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

A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to Duac® Topical Gel Clindamycin 1%/Benzoyl Peroxide 5% (Stiefel) in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 650 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel	Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) applied once a day in the evening for 77 days (11 weeks)
DRUG	Duac® Topical Gel	Duac® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel (Stiefel) applied once a day in the evening for 77 days (11 weeks)
DRUG	Placebo Topical Gel	Placebo (Vehicle) Topical Gel (Taro Pharmaceuticals Inc.) applied once a day in the evening for 77 days (11 weeks)

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-06-01
• Completion: 2013-08-01
• First posted: 2013-01-17
• Last updated: 2014-01-22