NCT02595034

A Study CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® Gel in the Treatment of Acne Vulgaris

A Randomized Double Blind Multiple Center Placebo Controlled Study Comparing CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl Peroxide Gel 1%/5% and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel

Detailed description

The objectives of this study are to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl Peroxide Gel 1%/5% (Taro Pharmaceuticals Inc.) and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, US) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo control

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Clindamycin and Benzoyl Peroxide Gel 1%5%	Clindamycin and Benzoyl Peroxide Gel 1%5% (Taro Pharmaceuticals Inc.)
DRUG	BenzaClin® Topical Gel	BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, U.S.)
DRUG	Placebo	Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-10-01
• Completion: 2015-11-01
• First posted: 2015-11-03
• Last updated: 2017-05-04