drugset / Trial / NCT02616614

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

NCT02616614 ↗

Phase 3 Completed 862 enrolled Actavis Inc.
RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2015-05
Primary completion
2015-10
Completion
2015-11

Outcome

Met primary endpoint

registry analysis (superiority test); Generic Clindamycin and Benzoyl Peroxide; p = 0.0001; ANOVA NCT02616614 ↗

registry analysis (superiority test); Generic Clindamycin and Benzoyl Peroxide; p = 0.0002; ANOVA NCT02616614 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Clindamycin/benzoyl peroxide Unknown 1.2 % Topical
Subject Clindamycin/benzoyl peroxide Unknown 3.75 % Topical

Indications