Two hundred fifty-one patients with papulopustular rosacea with persistent erythema and telangiectasia were randomly assigned to receive, in double-blind fashion, a 15% azelaic acid gel or 0.75% metronidazole gel. The respective treatments were applied topically twice a day for 15 weeks. Azelaic acid gel was more effective than metronidazole gel, as demonstrated by a greater reduction in the mean number of lesions (-12.9 vs. -10.7; p = 0.003) and by a greater mean percent decrease in inflammatory lesions (-72.7% vs. -55.8%; p < 0.001). An improvement in the severity of erythema was seen in 56% of patients receiving azelaic acid and in 42% of those receiving metronidazole (p = 0.02). Neither treatment had an effect on telangiectasia. Both the investigator's global assessment (p = 0.02) and overall assessment of improvement (p = 0.005) showed a significant advantage for azelaic acid gel. No serious adverse events were reported, although minor skin irritation occurred in 89% and 96% of the patients in the azelaic acid and metronidazole groups, respectively.
Comment: Azelaic acid is a nontoxic 9-carbon dicarboxylic acid that has been shown to be effective as a topical treatment for acne vulgaris, rosacea, and some hyperpigmentary disorders. The results of the present study demonstrate that azelaic acid is at least as effective as, and probably more effective than, standard therapy (topical metronidazole) as a treatment for rosacea. Azelaic acid for topical application is available both by prescription and over the counter; the prescription version costs substantially more than the OTC preparations. While it is generally well tolerated, azelaic acid tends to cause minor skin irritation. It has been said that topical application of azelaic acid can, on rare occasions, cause a loss of pigmentation of normal skin, but some researchers have disputed that statement.
Elewski BE, et al. A comparison of 15% azelaic acid gel and 0.75% metronidazole gel in the topical treatment of papulopustular rosacea: results of a randomized trial. Arch Dermatol 2003;139:1444-1450.
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