A Comparison of 15% Azelaic Acid Gel and 0.75% Metronidazole Gel in the Topical Treatment of Papulopustular Rosacea: Results of a Randomized Trial | Dermatology | JAMA Dermatology | JAMA Network
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Dahl  MV Pathogenesis of rosacea.  Adv Dermatol. 2001;1729- 45PubMedGoogle Scholar
Wilkin  JK Rosacea: pathophysiology and treatment.  Arch Dermatol. 1994;130359- 362PubMedGoogle ScholarCrossref
Zuber  TJ Rosacea.  Prim Care. 2000;27309- 318PubMedGoogle ScholarCrossref
Cohen  AFTiemstra  JD Diagnosis and treatment of rosacea.  J Am Board Fam Pract. 2002;15214- 217PubMedGoogle Scholar
Plewig  GKligman  AM Acne and Rosacea. 3rd ed. Berlin, Germany Springer-Verlag2000;460
Wilkin  JDahl  MDetmar  M  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;46584- 587PubMedGoogle ScholarCrossref
Rebora  A The management of rosacea.  Am J Clin Dermatol. 2002;3489- 496PubMedGoogle ScholarCrossref
Thiboutot  DM Acne and rosacea: new and emerging therapies.  Dermatol Clin. 2000;1863- 71PubMedGoogle ScholarCrossref
Bjerke  RFyrand  OGraupe  K Double-blind comparison of azelaic acid 20% cream and its vehicle in treatment of papulopustular rosacea.  Acta Derm Venereol. 1999;79456- 459PubMedGoogle ScholarCrossref
Carmichael  AJMarks  RGraupe  KAZaumseil  RP Topical azelaic acid in the treatment of rosacea.  J Dermatol Treat. 1993;4 (suppl 1) S19- S22Google ScholarCrossref
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;40961- 965PubMedGoogle ScholarCrossref
Akamatsu  HKomura  JAsada  YMiyachi  YNiwa  Y Inhibitory effect of azelaic acid on neutrophil functions: a possible cause for its efficacy in treating pathogenetically unrelated diseases.  Arch Dermatol Res. 1991;283162- 166PubMedGoogle ScholarCrossref
Passi  SPicardo  MZompetta  C  et al.  The oxyradical-scavenging activity of azelaic acid in biological systems.  Free Radic Res Commun. 1991;1517- 28PubMedGoogle ScholarCrossref
November 2003

A Comparison of 15% Azelaic Acid Gel and 0.75% Metronidazole Gel in the Topical Treatment of Papulopustular Rosacea: Results of a Randomized Trial

Author Affiliations

From the Departments of Dermatology, University of Alabama at Birmingham (Dr Elewski), Wake Forest University, Winston-Salem, NC (Dr Fleischer), and irginia Medical School, Norfolk (Dr Pariser). The authors received financial compensation from Berlex Laboratories, Inc, Montville, NJ, for serving as principal investigators for this study.

Arch Dermatol. 2003;139(11):1444-1450. doi:10.1001/archderm.139.11.1444

Objective  To compare the efficacy and safety of a novel formulation of 15% azelaic acid gel (Finacea; Berlex Laboratories, Inc, Montville, NJ) with 0.75% metronidazole gel (MetroGel; Galderma Laboratories LP, Fort Worth, Tex) as topical therapy for moderate, papulopustular facial rosacea.

Design  Multicenter, double-blind, randomized, parallel-group study.

Setting  Thirteen US centers.

Patients  A total of 251 patients with papulopustular rosacea with persistent erythema and telangiectasia.

Interventions  Patients were randomized to receive azelaic acid gel or metronidazole gel twice daily for 15 weeks.

Main Outcome Measures  Nominal and percent change in inflammatory lesion count, change in erythema and telangiectasia severity ratings, investigator's global assessment of rosacea, and investigator's and patient's overall improvement ratings.

Results  Azelaic acid gel was superior to metronidazole gel in reduction of mean nominal lesion count (–12.9 vs –10.7, respectively) (P = .003) and mean percent decrease in inflammatory lesions (–72.7% vs –55.8%, respectively) (P<.001). With respect to erythema severity, 56% of azelaic acid gel–treated patients were rated improved vs 42% of metronidazole gel–treated patients (P = .02). The effectiveness of metronidazole gel on these variables seemed to plateau after week 8, whereas azelaic acid gel demonstrated progressive improvement through week 15. Neither treatment had a clinically appreciable effect on telangiectasia. Both the investigator's global assessment (P = .02) and overall assessment of improvement (P = .005) showed a significant therapeutic advantage for azelaic acid gel. Azelaic acid gel also scored higher on the patient's overall assessment of efficacy. Both treatments were rated as having high cosmetic acceptability. No serious or systemic treatment–related adverse events were reported in either group.

Conclusion  Use of 15% azelaic acid gel twice daily for 15 weeks demonstrated significant superiority over using 0.75% metronidazole gel in improving principal signs of rosacea (inflammatory lesions and erythema).