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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
601
Dermatology Research of Arkansas
Little Rock, Arkansas, United States
Mean Percent Reduction from Baseline in Non-Nodular Inflamed Lesion Count
Per Protocol Population (PPP) was assessed for the mean percent reduction compared to baseline in non-nodular lesion count (papules and pustules) at Day 84. If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.
Time frame: 84 days
Mean Percent Reduction from Baseline in Non-Inflamed Lesion Count
Per Protocol Population (PPP) was assessed for the mean percent reduction in non-inflamed lesion count (open and closed comedones) compared with baseline at Day 84. If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.
Time frame: 84 days
Safety Analysis
All 601 patients randomized and dispensed study drug were included in the safety analysis. The frequency, severity, and relationship to the study drug for adverse events in each treatment group were used to compare the safety of the study medications.
Time frame: 84 Days
Mean Numerical Reduction in Inflamed Lesion Counts
Secondary measure of bioequivalence using the Intent-to-Treat (ITT) population.
Time frame: 84 Days
Mean Numerical Reduction in Non-Inflamed Lesion Counts
Secondary measure of bioequivalence using the Intent-to-Treat (ITT) population.
Time frame: 84 Days
Proportion of Patients Considered a "Clinical Success" or "Clinical Failure"
Secondary measure of bioequivalence using the Intent-to-Treat (ITT) population. "Clinial Success" or "Clinical Failure" is defined by the Physician's Global Assessment.
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Time frame: 84 Days