August 2006

Azelaic Acid in the Treatment of Papulopustular RosaceaA Systematic Review of Randomized Controlled Trials

Author Affiliations

Author Affiliations: Departments of Dermatology (Ms Liu and Drs Smith and Farmer) and Internal Medicine (Dr Basta), Eastern Virginia Medical School, and Sentara Healthcare (Dr Basta), Norfolk. Ms Liu is now with the Department of Dermatology, Yale University, New Haven, Conn; Dr Smith, Department of Dermatology, Case Western Reserve University, Cleveland, Ohio; and Dr Farmer, Departments of Dermatology and Pathology, Virginia Commonwealth University, Richmond, and The Johns Hopkins University, Baltimore, Md.


Copyright 2006 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2006

Arch Dermatol. 2006;142(8):1047-1052. doi:10.1001/archderm.142.8.1047

Objective  To evaluate the clinical efficacy of topical 20% azelaic acid cream and 15% azelaic acid gel compared with their respective vehicles and metronidazole gel in the treatment of papulopustular rosacea.

Data Sources  Electronic searches of MEDLINE, EMBASE, BIOSIS, and SciSearch through July or August 2004 and the Cochrane Central Register of Controlled Trials through 2004 (issue 3). We performed hand searches of reference lists, conference proceedings, and clinical trial databases. Experts in rosacea and azelaic acid were contacted.

Study Selection  Randomized controlled trials involving topical azelaic acid (cream or gel) for the treatment of rosacea compared with placebo or other topical treatments. Two authors independently examined the studies identified by the searches. Ten studies were identified, of which 5 were included (873 patients).

Data Extraction  Two authors independently extracted data from the included studies, then jointly assessed methodological quality using a quality assessment scale.

Data Synthesis  Because standard deviation data were not available for 4 of the 5 studies, a meta-analysis could not be conducted. Four of the 5 studies demonstrated significant decreases in mean inflammatory lesion count and erythema severity after treatment with azelaic acid compared with vehicle. None of the studies showed any significant decrease in telangiectasia severity.

Conclusions  Azelaic acid in 20% cream and 15% gel formulations appears to be effective in the treatment of papulopustular rosacea, particularly in regard to decreases in mean inflammatory lesion count and erythema severity. Compared with metronidazole, azelaic acid appears to be an equally effective, if not better, treatment option.