NCT02616614

Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne Vulgaris

Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Bioequivalence of a Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel to Onexton® Gel in Subjects With Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 862 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75% gel. This study is designed to evaluate the safety and efficacy of this formulation in subjects with Acne Vulgaris

Detailed description

This is a randomized, double blind, three-arm, parallel group, placebo control bioequivalence study with clinical endpoint, at multiple study sites, designed to establish bioequivalence of clindamycin 1.2% and benzoyl peroxide 3.75% gel of Actavis and Onexton® (clindamycin 1.2% and benzoyl peroxide 3.75%) gel in the treatment of subjects with Acne Vulgaris. The primary objective is to evaluate the bioequivalence of a generic of clindamycin 1.2% and benzoyl peroxide 3.75% gel to Onexton® in the treatment of subjects with acne vulgaris.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Onexton	Topical gel for treating acne
DRUG	Clindamycin/benzoyl peroxide gel	Generic Clindamycin/benzoyl peroxide gel for treating acne
DRUG	Placebo	Vehicle gel used as a placebo

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-10-01
• Completion: 2015-11-01
• First posted: 2015-11-30
• Last updated: 2020-05-27
• Results posted: 2020-05-27

Locations

17 sites across 1 country: United States