NCT02465632

To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) to the Marketed Product BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% (Valeant Pharmaceuticals, US) in the Treatment of Acne Vulgaris.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,100 (actual)
• Sponsor: Glenmark Pharmaceuticals Ltd. India · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5% topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel, Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne vulgaris.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
DRUG	BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
DRUG	Placebo

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2015-06-08
• Last updated: 2017-06-28
• Results posted: 2017-06-28

Locations

15 sites across 2 countries: United States, Belize