This study is to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl Peroxide Gel 1%/5% and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel
The objectives of this study are to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl Peroxide Gel 1%/5% (Taro Pharmaceuticals Inc.) and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, US) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo control
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,000
Clindamycin and Benzoyl Peroxide Gel 1%5% (Taro Pharmaceuticals Inc.)
BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, U.S.)
Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)
Change in inflammatory lesion count
Mean percent change from baseline to week 10 (study day 70) in the inflammatory (papules and pustules) lesion counts.
Time frame: Week 10 (day 70)
Change in non-inflammatory lesion count
Mean percent change from baseline to week 10 (study day 70) in the non-inflammatory (open and closed comedones) lesion counts.
Time frame: Week 10 (day 70)
Clinical response of success
The proportion of subjects with a clinical response of success at week 10 (study day 70) defined as an Investigator's Global Assessment score at least 2 grades less than baseline assessment.
Time frame: Week 10 (day 70)
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