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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

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

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

Conditions

Rosacea

Intervention

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

Location

T. Joseph Raoof MD Inc Encino Research Center
Encino
California
United States
91436

Status

Completed

Source

Actavis Inc.

Results (where available)

View Results

Links

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

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Azelaic Acid Foam 15% in the Treatment of Papulopustular Rosacea

This research study is being performed to evaluate the photographic evidence of the efficacy and tolerability of Azelaic Acid Foam 15% in the treatment of papulopustular rosacea.

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For this work, the aim was to investigate the adsorption of the tannic acid (TA)/sodium caseinate (SC) nanocomplexes at the air/water interface,then to research its relationship with foam properties...

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