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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,100
Glenmark Investigational Site 13
Anaheim, California, United States
Glenmark Investigational Site 6
Long Beach, California, United States
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.
Time frame: 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.
Time frame: Baseline and 10 Weeks
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Glenmark Investigational Site 15
Los Angeles, California, United States
Glenmark Investigational Site12
West Covina, California, United States
Glenmark Investigational Site 4
Brandon, Florida, United States
Glenmark Investigational Site 1
Miami, Florida, United States
Glenmark Investigational Site 8
Miami, Florida, United States
Glenmark Investigational Site 9
Miramar, Florida, United States
Glenmark Investigational Site 2
St. Petersburg, Florida, United States
Glenmark Investigational Site 5
Louisville, Kentucky, United States
...and 5 more locations