The objective of these studies was to evaluate the efficacy, tolerability, and safety of a new formulation of 15% azelaic acid gel (AzA gel), for the topical treatment of moderate papulopustular rosacea. Two multicenter, double-blind, randomized, parallel-group, vehicle-controlled studies were conducted using identical criteria. Overall, 329 patients were enrolled in study 1 and 335 patients in study 2.
The results of both studies demonstrated AzA gel to be better over vehicle in the topical treatment of moderate papulopustular rosacea. AzA gel yielded statistically significantly higher reductions in mean inflammatory lesion count than vehicle: 58% versus 40% in study 1; 51% versus 39% in study 2. A higher number of patients treated with AzA gel experienced improvement in erythema compared with vehicle gel: 44% versus 29% in study 1; 46% versus 28% in study 2. The researchers' global assessment of therapeutic success in terms of a clear, minimal, or mild final result was achieved in 61% and 62% of patients treated with AzA gel in studies 1 and 2, respectively (40% and 48%). Patients reported mild irritation as the most serious side effect. The authors concluded that AzA gel is better for the treatment of moderate papulosquamous rosacea.
JDD Article Evaluation
Our armamentarium of medications for the treatment of rosacea is broad and variable in results. Metronidazole is probable the most commonly used therapy, but it has limited effects on the erythema of rosacea. Laser therapy seems to have better response for erythema of rosacea, but it is costly and the erythema tends to recur. It may be helpful to compare metronidazole versus azelaic acid in a double-blind long term study. Furthermore, a cost effective analysis of the long term resolution of erythema using AzA versus laser therapy would be interesting.
1. Mark KA, Sparacio RM, Voigt A, Marenus K, Sarnoff DS. Objective and quantitative improvement of rosacea-associated erythema after intense pulsed light treatment. Dermatol Surg 2003 Jun; 29(6):600-4.
Diane Thiboutot, Ruth Thieroff-Ekerdt, Klaus Graupe. J Am Acad Dermatol 2003; 48:836-45.
COPYRIGHT 2003 Journal of Drugs in Dermatology
COPYRIGHT 2003 Gale Group
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