The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%).
The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%) in the treatment of acne vulgaris and to demonstrate the superiority of the test and reference products over the placebo control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,077
Tazarotene Cream 0.1% applied to lightly cover the entire face once daily for 84 consecutive days.
Tazorac® applied to lightly cover the entire face once daily for 84 consecutive days.
Placebo (vehicle of the test product) applied to lightly cover the entire face once daily for 84 consecutive days.
Change in inflammatory lesion counts
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Time frame: Week 12
Change in non-inflammatory lesion counts
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
Time frame: Week 12
Clinical response of success
The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment
Time frame: Week 12
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