Finacea (azelaic acid) Gel, 15%
Company: Berlex Laboratories
Approval Status: January 2003
Treatment for: Inflammatory papules and pustules of mild to moderate rosacea.
Areas: Dermatology/Plastic Surgery
| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |
General Information
Finacea (azelaic acid 15%) is a topical gel indicated for the treatment of inflammatory papules and pustules of mild to moderate rosacea. The gel formulation of Finacea provides improved drug penetration compared with the cream formulation.
Finacea is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation.
Clinical 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.
Side Effects
Adverse events associated with the use of Finacea may include (but are not limited to) the following:
- Burning and Stinging
- Pruritus
- Scaling/Dry Skin/Xerosis
- Edema
- Acne
- Seborrhea
- Photosensitivity
- Skin Disease
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.
Azelaic acid is mainly excreted unchanged in the urine, but undergoes some ß-oxidation to shorter chain dicarboxylic acids.
Literature References
Del Rosso, J.Q. A status report on the medical management of rosacea: focus on topical therapies. Cutis. 2002 Nov;70(5):271-5.
Rebora A. The management of rosacea. Am J Clin Dermatol. 2002;3(7):489-96. Review.
Additional Information
For additional information about Finacea or rosacea, please contact Berlex Laboratories
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
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