At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 1,100 enrolled

Drug / intervention

Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel +2 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02465632

NCT02465632Phase 3Completed

Compare CT.gov

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.

Glenmark Pharmaceuticals Ltd. India·interventional·Posted Jun 8, 2015·Updated Jun 28, 2017

In Brief

A Phase 3 clinical trial evaluating Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel, BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%, and 1 other intervention for Acne Vulgaris. Completed, enrolled 1,100 participants across 15 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAcne Vulgaris

CountriesBelize, United States

Collaborators--

Timeline

Phase 3CompletedFinished

201520162017201820192020202120222023202420252026

Enrollment StartApr 2015

First PostedJun 2015

Primary CompletionNov 2015

Study CompletionDec 2015

TodayJul 2026

First PostedJun 8, 2015

Enrollment StartApr 1, 2015

Primary CompletionNov 1, 2015

Study CompletionDec 1, 2015

TodayJul 2, 2026

Enrollment to primary: 7 monthsPosted 11.1 years ago

Interventions

Clindamycin 1%/Benzoyl Peroxide 5% Topical Geldrug

BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%drug

Placebodrug