Efficacy and safety of azelaic acid (15%) gel as a new treatment for papulopustular rosacea: Results from two vehicle-controlled, randomized phase III studies


      Background: Rosacea is a common, chronic dermatosis for which safe and effective new treatment options are needed. Objective: The objective of these studies was to evaluate the efficacy, tolerability, and safety of a new formulation of 15% azelaic acid (15%) gel (AzA gel), for the topical treatment of moderate, papulopustular rosacea. Methods: Two multicenter, double-blind, randomized, parallel-group, vehicle-controlled studies were conducted using identical study designs, patient-selection criteria, and efficacy end points. Overall, 329 patients were enrolled in study 1 and 335 patients in study 2. Results: Both studies consistently demonstrated the superiority of AzA gel 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%, study 1 (P = .0001); 51% versus 39%, study 2 (P = .0208). Significantly higher proportions of patients treated with AzA gel experienced improvement in erythema compared with vehicle gel: 44% versus 29%, study 1 (P = .0017); 46% versus 28%, study 2 (P = .0005). Using the investigator's global assessment, 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, which was significantly superior to the result achieved with vehicle (40% and 48%, respectively) (P < .0001, study 1; P = .0127, study 2). No serious, treatment-related adverse events were reported. Conclusion: The results of these 2 controlled studies demonstrate that AzA gel, used twice daily, is an efficacious, safe, and well-tolerated topical treatment for moderate, papulopustular rosacea. (J Am Acad Dermatol 2003;48:836-45.)
      To read this article in full you will need to make a payment
      AAD Member Login
      AAD Members, full access to the journal is a member benefit. Use your society credentials to access all journal content and features
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Wilkin JK
        Rosacea: pathophysiology and treatment.
        Arch Dermatol. 1994; 130: 359-362
        • Wilkin J
        • Dahl M
        • Detmar M
        • Drake L
        • Feinstein A
        • Odom R
        • et al.
        Standard classification of rosacea: report of the National Rosacea Society expert committee on the classification and staging of rosacea.
        J Am Acad Dermatol. 2002; 46: 584-587
        • Rebora A
        The management of rosacea.
        Am J Clin Dermatol. 2002; 3: 489-496
        • Maddin S
        A comparison of topical azelaic acid 20% cream and topical metronidazole 0.75% cream in the treatment of patients with papulopustular rosacea.
        J Am Acad Dermatol. 1999; 40: 961-965
        • Bjerke R
        • Fyrand O
        • Graupe K
        Double-blind comparison of azelaic acid 20% cream and its vehicle in treatment of papulopustular rosacea.
        Acta Derm Venereol. 1999; 79: 456-459
        • Carmichael AJ
        • Mark R
        • Graupe KA
        • Zaumseil RP
        Topical azelaic acid in the treatment of rosacea.
        J Dermatol Treat. 1993; 4: S19-S22
        • Bergfeld WF
        A lifetime of healthy skin: implications for women.
        Int J Fertil Womens Med. 1999; 44: 83-95
        • Passi S
        Pharmacology and pharmacokinetics of azelaic acid.
        Rev Contemp Pharmacother. 1993; 4: 441-447
        • Bojar RA
        • Holland KT
        Azelaic acid: a review of its antimicrobial properties.
        Rev Contemp Pharmacother. 1993; 4: 403-414
        • Passi S
        • Picardo M
        • Zompetta C
        • De Luca C
        • Breathnach AS
        • Nazzaro-Porro M
        The oxyradical-scavenging activity of azelaic acid in biological systems.
        Free Radic Res Commun. 1991; 15: 17-28
        • Akamatsu H
        • Komura J
        • Asada Y
        • Miyachi Y
        • Niwa Y
        Inhibitory effect of azelaic acid on neutrophil functions: a possible cause for its efficacy in treating pathogenetically unrelated diseases.
        Arch Dermatol Res. 1991; 283: 162-266
        • Akamatsu H
        • Oguchi M
        • Nishijima S
        • Asada Y
        • Takahashi M
        • Ushijima T
        • et al.
        The inhibition of free radical generation by human neutrophils through the synergistic effects of metronidazole with palmitoleic acid: possible mechanism of action of metronidazole in rosacea and acne.
        Arch Dermatol Res. 1990; 282: 449-454
        • Nazzaro-Porro M
        • Passi S
        • Picardo M
        • Balus L
        • Breathnach AS
        L'acido azelaico nella rosacea?.
        G Ital Dermatol Venerol. 1991; 126: 19-27
        • Thiboutot D
        New treatments and therapeutic strategies for acne.
        Arch Fam Med. 2000; 9: 179-187
        • Zuber TJ
        Prim Care. 2000; 27: 309-318