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A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea

Rosacea Clinical Trial

Official title:
A Multicenter, Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate Safety and Clinical Equivalence of a Generic Azelaic Acid Foam, 15% and the Reference Listed Finacea® (Azelaic Acid) Foam,15% in Patients With Moderate Facial Rosacea

Clinical Trial Summary

The objectives of this study were to compare the safety and efficacy profiles of a generic Azelaic Acid Foam, 15% to the reference listed Finacea® (azelaic acid) Foam, 15% and to demonstrate therapeutic equivalence and safety of the two active foams in the treatment of moderate facial rosacea, and to demonstrate superiority of the Reference and Test products over the Vehicle.

Clinical Trial Description

Topical azelaic acid is used to treat inflammatory papules and pustules of mild to moderate rosacea. Other topical therapies and oral antibiotics are also used to treat rosacea symptoms. Finacea® (azelaic acid) Foam, 15% contains azelaic acid, a naturally occurring saturated dicarboxylic acid that has proven anti-inflammatory effects, as well as anti-keratinizing and antimicrobial actions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03287791
Study type Interventional
Source Actavis Inc.
Contact
Status Completed
Phase Phase 3
Start date July 19, 2016
Completion date June 22, 2017
View Details
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