To demonstrate the efficacy, therapeutic equivalence and safety of Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and US Reference Listed Drug, Canadian Reference Product over the placebo control in the treatment of acne vulgaris.
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and each active treatment to a placebo control in the treatment of acne vulgaris.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,000
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
Taro Pharmaceuticals USA Inc.
Hawthorne, New York, United States
Demonstrate the therapeutic equivalence, efficacy and safety of the Investigational Product
Percentage change in the inflammatory (papules and pustules) \& non-inflammatory (open and closed comedones) of the lesion counts.
Time frame: Baseline to Week 12
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A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.