SAN FRANCISCO, CA -- March 25, 2003 -- A topical gel consisting of benzoyl peroxide 5% and clindamycin 1% is effective for treatment of moderate rosacea, according to results of a double-blind, multicentre study.

D. Breneman, MD, from University Dermatology Consultants, Cincinnati, Ohio, United States, and colleagues randomised 53 adults with stage II rosacea to treatment with a combination topical agent containing 5% benzoyl peroxide and 1% clindamycin or a placebo gel for 12 weeks. The findings were presented in a poster here on March 23^rd at the 61^st Annual Meeting of the American Academy of Dermatology.

The study included patients who had between eight and 50 papules or pustules on the face, no more than two nodules and Overall Rosacea Severity Assessment (ORSA) scores of at least 2.5. Patients with concomitant acne vulgaris or seborrhea dermatitis were excluded from the study.

By Week 6, patients using the combination gel achieved an average reduction in papules and pustules from baseline of over 70%. These reductions were maintained to the end of the 12-week trial and were significantly superior to placebo (P</=0.02).

Patients treated with the combination gel also experienced significant improvements in symptoms of rosacea, compared with baseline scores and compared with placebo (P</=0.01 for both). Patients taking the combination gel had approximately 30% improvement in ORSA score compared with 10% in those taking the placebo. Patients' impressions of improvement were also higher among those who used the active agent versus the placebo group.

No serious adverse events occurred in either group. The most common side effects seen in patients taking the combination gel but not the placebo were burning and itching at the application site.

Based on these findings, the authors concluded that the 5% benzoyl peroxide and 1% clindamycin combination gel is superior to placebo for the treatment of moderate rosacea and is well tolerated.

The study was sponsored by Dermik Laboratories.


[Study title: Double Blind, Multicenter, Comparison Study of Combination Benzoyl Peroxide/clindamycin or Placebo in Patients with Moderate Rosacea. Abstract p43]

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