A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris

Sun Pharmaceutical Industries, Inc.844 enrolled

Overview

The objectives of this study are to evaluate the therapeutic equivalence and safety.

The objectives of this study are to evaluate the therapeutic equivalence and safety of the test product Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to the reference product Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of these test and reference products over the placebo control.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

844

Conditions

Acne Vulgaris

Interventions

Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%DRUG

Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% (Taro Pharmaceuticals Inc.)

Onexton™ GelDRUG

Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) (Valeant Pharmaceuticals LLC)

PlaceboDRUG

Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)

Eligibility

Sex: ALLMin age: 12 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. * Must have a minimum ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face. * Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment. Exclusion Criteria: * Female subjects who are pregnant, nursing or planning to become pregnant during study participation. * A history or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis. * A history of hypersensitivity or allergy to clindamycin, benzoyl peroxide and/or any of the study medication ingredients and its excipients.

Outcomes

Primary Outcomes

Demonstration of Bioequivalence

Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts

Time frame: Week 12

Secondary Outcomes

Clinical response of success

The proportion of subjects with a clinical response of success at week 12 defined as an Investigator's Global Assessment score that is at least 2 grades less than the baseline assessment.

Time frame: Week 12

Data from ClinicalTrials.gov

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