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

2017-09-20 01:53:21 | BioPortfolio


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


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




Azelaic acid (Finacea®) Foam, Generic Azelaic Acid Foam, Vehicle Foam


T. Joseph Raoof MD Inc Encino Research Center
United States




Actavis Inc.

Results (where available)

View Results


Published on BioPortfolio: 2017-09-20T01:53:21-0400

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