To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
* Drug: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris. Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4. Exclusion Criteria: Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis. Subject has active cystic acne. Subject has acne conglobata. Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel<br>apply a thin layer of gel to the face | Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel<br> <br> |
| Active Comparator: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%<br>apply a thin layer of the gel to the face | Drug: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%<br> <br> |
| Placebo Comparator: Placebo topical gel<br>apply a thin layer of the gel to the face | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules) | The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated. | Baseline and 10 Weeks | 
| Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones) | The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated. | Baseline and 10 Weeks |