Acne Vulgaris Clinical Trial
Official title:
A Randomized, Double-Blind, Multiple-Site, Placebo Controlled, Parallel Design, Clinical Study to Evaluate the Bioequivalence of Adapalene Gel 0.1% (PLIVA Research & Development Ltd.) Compared to Differin® (Adapalene 0.1%) Topical Gel (Galderma Laboratories) in Patients With Acne Vulgaris
The objective of this study was to evaluate the efficacy and safety of the test formulation of adapalene gel 0.1% (PLIVA Research & Development Ltd.) as compared to the already marketed formulation, Differin® (adapalene 0.1%) topical gel (Galderma Laboratories) in patients with acne vulgaris.
Criteria for Evaluation: FDA Bioequivalence Criteria for Comparative Clinical Endpoint
Studies.
Statistical Methods: FDA Bioequivalence Statistical Methods for Comparative Clinical
Endpoint Studies.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double-Blind
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