General Information

Finacea Foam contains 15% (w/w) azelaic acid, a naturally-occurring saturated dicarboxylic acid.

Finacea is specifically indicated for the treatment of inflammatory papules and pustules of mild to moderate rosacea.

Finacea is supplied as a foam for topical use. Shake well before use. Cleanse affected area(s) using only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before application of Finacea Foam. Apply Finacea Foam twice daily (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). For a single application, dispense the smallest amount of foam necessary to adequately cover the affected area(s) with a thin layer. Use Finacea Foam continuously over 12 weeks. Wash hands immediately following application. Cosmetics may be applied after the application of Finacea Foam has dried. Reassess the diagnosis if no improvement is observed upon completing 12 weeks of therapy. Avoid the use of occlusive dressings or wrappings. Instruct patients to avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.

Mechanism of Action

Finacea (azelaic acid) Gel, 15%, contains azelaic acid, a naturally occurring saturated dicarboxylic acid. Azelaic acid is a white, odorless crystalline solid that is poorly soluble in water, but well soluble in alcohol. The mechanism by which azelaic acid interferes with the pathogenic events in rosacea is unknown, but an anti-inflammatory effect was found in vitro.

Clinical Trial Results

The approval of Finacea Gel, 15%, for the treatment of mild to moderate papulopustular rosacea, was based on 2 clinical trials comprising a total of 664 (333 active to 331 vehicle) subjects. The primary efficacy endpoints were change from baseline in inflammatory lesion counts and the treatment success, defined as a score of clear or minimal with at least a 2-step reduction from baseline. Scores were assessed on the Investigator’s Global Assessment (IGA) scale.

Both multicenter, randomized, double blind, and vehicle-controlled studies demonstrated a statistically significant difference in reducing the number of inflammatory papules and pustules associated with rosacea. Data showed that Finacea resulted in a higher treatment score compared to its vehicle. Both trials were 12-week studies with identical protocols.