To demonstrate the efficacy, therapeutic equivalence and safety of tretinoin gel microsphere, 0.04% (Sun Pharmaceutical Industries, Inc.) and RETIN-A MICRO ® (tretinoin) gel microsphere, 0.04% (Reference Listed Drug) in the treatment of acne vulgaris.
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Tretinoin Gel Microsphere, 0.04% (Sun Pharmaceutical Industries, Inc.) and RETIN-A MICRO ® (Tretinoin) Gel Microsphere, 0.04% (Reference Listed Drug) in the treatment of acne vulgaris.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,043
The investigational product will be applied topically to the affected areas of the face lightly once daily at bedtime, avoiding the eyes, mouth, and other mucous membranes for 84 consecutive days.
The investigational product will be applied topically to the affected areas of the face lightly once daily at bedtime, avoiding the eyes, mouth, and other mucous membranes for 84 consecutive days.
The investigational product will be applied topically to the affected areas of the face lightly once daily at bedtime, avoiding the eyes, mouth, and other mucous membranes for 84 consecutive days.
Sun Pharmaceutical Industries, Inc.
Hawthorne, New York, United States
Demonstrate & evaluate the therapeutic, equivalence and safety of the investigational product
Mean Percentage change in the inflammatory (papules and pustules) \& non-inflammatory (comedones) lesion counts
Time frame: Baseline to Week 12
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