This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,125
Topical gel
Topical Placebo gel
Site 11
Encino, California, United States
Site 10
Sherman Oaks, California, United States
Site 1
Brandon, Florida, United States
Site 4
Miramar, Florida, United States
Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks
Time frame: Percent change from baseline to 12 weeks
Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week
Time frame: Percent change in baseline to 12 weeks
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Site 5
Miramar, Florida, United States
Site 2
Tampa, Florida, United States
Site 3
Tampa, Florida, United States
Site 12
High Point, North Carolina, United States
Site 8
El Paso, Texas, United States
Site 9
El Paso, Texas, United States
...and 2 more locations