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

Study Overview
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Brief Summary
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The objectives of this study are to evaluate the therapeutic equivalence and safety.

Detailed Description
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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.

Official Title
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A Multi Center Double Blind Randomized Placebo Controlled Parallel Group Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%
* Drug: Onexton™ Gel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clindamycin and BPO Gel 1.2%/3.75%<br>Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% applied to the face once daily for 84 days. | Drug: Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%<br>* Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% (Taro Pharmaceuticals Inc.)<br>* Other names: Clindamycin, BPO;|
| Active Comparator: Onexton™ Gel<br>Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) applied to the face once daily for 84 days. | Drug: Onexton™ Gel<br>* Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) (Valeant Pharmaceuticals LLC)<br>* Other names: Clindamycin, BPO;|
| Placebo Comparator: Placebo<br>Placebo (vehicle of the test product) applied to the face once daily for 84 days. | Drug: Placebo<br>* Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstration of Bioequivalence | Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 12 |