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The use of topical azelaic acid 15% gel or metronidazole 0.75% gel for the treatment of rosacea: evaluation of a single-site comparative trial subset 1

      Topical treatment for rosacea with either metronidazole or azelaic acid has been shown to be effective in reducing both inflammatory lesions and erythema in several studies. The longer track record and multiple studies associated with the use of topical metronidazole has established this agent in the “first tier” when selecting therapy for rosacea. Initial studies with azelaic acid completed in the 1990s utilizing the 20% cream formulation confirmed efficacy, but were small in terms of the number of patients evaluated. More recently, a 15% gel formulation of azelaic acid has been shown to deliver a greater amount of drug into skin based on penetration studies. Two parallel-group, double-blind, multi-center, 12 week studies comparing the efficacy of azelaic acid 15% gel (n=333) vs vehicle (n=331) in patients with papulopustular rosacea established statistically significant count, erythema in patients treated with active drug, with improvements noted in lesion counts, erythema and by physician and patient global assessments. The recent approval of azelaic acid 15% gel has provided another therapeutic choice in the “first tier” when selecting therapy for rosacea. A subsequent double-blind, multi-center 15-week trial evaluated the comparative efficacy of azelaic acid 15% gel (n=124) and metronidazole 0.75% gel (n=127) in patients with papulopustular rosacea, using the parameter evaluations completed in the vehicle-controlled studies. Both agents proved to be effective, with azelaic acid 15% gel demonstrating greater reduction in lesion counts and erythema and improvement in global assessments which were statistically significant. Tolerability profiles were favorable with both agents; azelaic acid 15% gel was associated with a higher likelihood of stinging, reported most often as transient and without interruption in therapy. This poster reviews the efficacy and safety results from a subset of patients evaluated at a single study site and discusses the use of both of these agents in the management of rosacea.