Pharmacology Update: Azelaic Acid Gel 15% (Finacea — Berlex)
Pharmacology Update: Azelaic Acid Gel 15% (Finacea—Berlex)
By William T. Elliott, MD, FACP, and James Chan, PharmD, PhD
Azelaic acid gel has been approved for the treatment of mild-to-moderate rosacea. This naturally occurring saturated dicarboxylic acid is formulated in an aqueous gel formation for this indication. Azelaic acid is currently available as a 20% cream (Azelex) for the treatment of acne vulgaris. The new 15% gel formulation represents the first drug approved for the treatment of rosacea in more than a decade. The 15% gel is to be marketed by Berlex for the treatment of rosacea under the trade name "Finacea."
Indications
Azelaic acid gel is indicated for topical treatment of inflammatory papules and pustules of mild-to-moderate rosacea.1
Dosage
A thin layer should be gently massaged into the affected area twice daily (morning and evening). The affected area should be cleaned with a very mild soap or soapless cleansing lotion and patted dry with a soft towel before application. Patients should be advised to avoid spicy, thermally hot foods and drinks, and alcoholic drinks.1 Patients hypersensitive to propylene glycol should not use Finacea.
Azelaic acid gel is supplied as 30 g tubes.
Potential Advantages
In a 15-week study comparing cream formulations of azelaic acid (20%) and metronidazole (0.75%) (n = 40), there was greater patient satisfaction for azelaic acid (92% vs 66%).2 In addition, azelaic acid had a more favorable physicians rating of global improvement at 9 weeks.
Potential Disadvantages
Common side effects (20% vs 2% for vehicle) include burning, stinging, or tingling. These are generally mild. Skin irritation is generally more prominent during the first few weeks of treatment. If irritation persists or is excessive, discontinuation of therapy should be considered. Other side effects are scaling, dry skin, or xerosis (6-10%).1
Comments
Azelaic acid is formulated in an aqueous gel to improve drug penetration compared with the cream for the treatment of rosacea.3 Efficacy was reported in 2 randomized vehicle-controlled studies involving 664 patients with mild-to-moderate rosacea.1 Percent reduction of inflammatory papules and pustules at the end of 12-weeks ranged from 50% to 57.9% for azelaic gel compared to 38.2% to 39.9% for the vehicle. The ranges for investigators’ global assessment were 61% to 62% and 40% to 48%, respectively. Comparative studies between gel formulations of azelaic acid and metronidazole are not currently available. The cost for azelaic acid gel is about 16% higher than of metronidazole gel, $36.60 compared to $31.40.
Clinical Implications
Rosacea is a common skin condition affecting middle-aged and older adults. It generally involves the cheeks, nose, chin, and forehead.4 It is characterized by facial redness and acne-like lesions. The disease can progress from frequent blushing to rhinophyma and possible ocular inflammation. Early treatment is advisable to deter progression to more severe disease. Nonpharmacologic treatment includes avoidance of triggers such as sun exposure, spicy food, and alcohol. Pharmacologic treatment includes oral antibiotics (eg, tetracyclines, metronidazole) or topical metronidazole.4,5 Azelaic gel provides another alternative.
Dr. Elliott is Chair, Formulary Committee, Northern California Kaiser Permanente and Asst. Clinical Professor of Medicine, University of California-San Francisco. Dr. Chan is Pharmacy Quality and Outcomes Manager, Kaiser Permanente, Oakland, CA.
References
1. Finaea Product Information. Berlex Laboratories. January 2003.
2. Maddin S. J Am Acad Dermatol. 1999;40(6 Pt 1):961-965.
3. Berlex Press Release.
4. Cohen AF, Tiemstra JD. J Am Board Fam Pract. 2002;15(3):214-217.
5. Rebora A. Am J Clin Dermatol. 2002;3(7):489-496.
Azelaic acid gel has been approved for the treatment of mild-to-moderate rosacea. This naturally occurring saturated dicarboxylic acid is formulated in an aqueous gel formation for this indication.Subscribe Now for Access
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