Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.
A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.1% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.1% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
455
Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
RETIN-A® (Tretinoin) Cream (Valeant)
Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
Catawba Research, LLC
Charlotte, North Carolina, United States
Demonstration of Bioequivalence
Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts
Time frame: 12 weeks
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