Clinical Trial: Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

Criteria for Evaluation: FDA Bioequivalence Criteria for Comparative Clinical Endpoint Studies.

Statistical Methods: FDA Bioequivalence Statistical Methods for Comparative Clinical Endpoint Studies.

Sponsor: Teva Pharmaceuticals USA

Current Primary Outcome:

• Mean Percent Reduction from Baseline in Non-Nodular Inflamed Lesion Count [ Time Frame: 84 days ]
  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 If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.
• Mean Percent Reduction from Baseline in Non-Inflamed Lesion Count [ Time Frame: 84 days ]
  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 If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.
• Safety Analysis [ Time Frame: 84 Days ]
  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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Mean Numerical Reduction in Inflamed Lesion Counts [ Time Frame: 84 Days ]
  Secondary measure of bioequivalence using the Intent-to-Treat (ITT) population.
• Mean Numerical Reduction in Non-Inflamed Lesion Counts [ Time Frame: 84 Days ]
  Secondary measure of bioequivalence using the Intent-to-Treat (ITT) population.
• Proportion of Patients Considered a "Clinical Success" or "Clinical Failure" [ Time Frame: 84 Days ]
  Secondary measure of bioequivalence using the Intent-to-Treat (ITT) population. "Clinial Success" or "Clinical Failure" is defined by the Physician's Global Assessment.

Original Secondary Outcome: Same as current

Information By: Teva Pharmaceuticals USA

Dates:
Date Received: August 13, 2010
Date Started: July 2007
Date Completion:
Last Updated: November 22, 2010
Last Verified: November 2010