Azelaic Acid

Azelaic acid 15% gel was approved for the treatment of rosacea in the U. S. in 2008, but has also been approved for the treatment of acne in many European countries, where it has demonstrated success. Two randomized, multicenter, controlled clinical trials compared the effects of azelaic acid 15% gel with those of topical benzoyl peroxide 5% or topical clindamycin 1%, all using a twice-daily dosing regimen. The primary endpoint in the intent-to-treat analysis was a reduction in inflammatory papules and pustules. Azelaic acid resulted in a 70% to 71% median reduction of facial papules and pustules compared with a 77% reduction with benzoyl peroxide 5% gel and a 63% reduction with clindamycin. Azelaic acid 15% gel was well-tolerated. In addition, a one-year European observational study conducted by dermatologists in private practice evaluated the safety and efficacy of azelaic acid 15% gel used as monotherapy or in combination with other agents in more than 1200 patients with acne. Most physicians (81.9%) described an improvement in patients’ symptoms after an average of 34.6 days, and 93.9% of physicians reported patient improvement after an average of 73.1 days. Both physicians and patients assessed azelaic acid 15% gel to be effective, with 74% of patients being “very satisfied” at the end of therapy. Azelaic acid 15% gel was considered “well-tolerated” or “very well-tolerated” by 95.7% of patients. (Sources: Journal of Drugs in Dermatology, January 2008, pages 13-16; and Journal of the American Academy of Dermatology, August 2000, Supplemental, pages 47-50.)