NCT01769235

Study Comparing Clindamycin Phosphate and Benzoyl Peroxide Gel to Acanya® Gel and Both to a Vehicle Control in the Treatment of Acne Vulgaris

A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Taro Pharmaceutical Inc.'s Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% to the Reference Listed Acanya® (Clindamycin Phosphate and Benzoyl Peroxide)Gel, 1.2%/2.5% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1,215 (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 safety and efficacy profiles of Taro Pharmaceutical Inc.'s Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/2.5% to Acanya® (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% and to demonstrate the superior efficacy of the two active formulations over that of the vehicle in the treatment of acne vulgaris.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%	Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% (Taro Pharmaceuticals Inc.)applied at approximately the same time once daily for 84 days (12 weeks).
DRUG	Acanya® Gel, 1.2%/2.5%	Acanya® (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% (Dow Pharmaceutical Sciences, Inc., marketed by Valeant Pharmaceuticals North America LLC)applied at approximately the same time once daily for 84 days (12 weeks).
DRUG	Vehicle of test product	Vehicle of test product (Taro Pharmaceuticals Inc.)applied at approximately the same time once daily for 84 days (12 weeks).

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-09-01
• Completion: 2013-12-01
• First posted: 2013-01-16
• Last updated: 2017-05-05