NCT01182636

Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 601 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Adapalene	0.1% Topical Gel
DRUG	Differin®	0.1% Topical Gel
DRUG	Placebo	Gel Base

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2010-08-17
• Last updated: 2010-11-24

Locations

22 sites across 2 countries: United States, Belize