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Double-blind, randomized, vehicle-controlled clinical trial of once-daily benzoyl peroxide/clindamycin topical gel in the treatment of patients with moderate to severe rosacea

Authors

  • Debra Breneman MD,

    Corresponding author
    1. From University Dermatology Consultants, Cincinnati, OH, The Savin Center, New Haven, CT, Dermik Laboratories, Berwyn, PA, and the Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, PA
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  • Ronald Savin MD,

    1. From University Dermatology Consultants, Cincinnati, OH, The Savin Center, New Haven, CT, Dermik Laboratories, Berwyn, PA, and the Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, PA
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  • Christine VandePol MD,

    1. From University Dermatology Consultants, Cincinnati, OH, The Savin Center, New Haven, CT, Dermik Laboratories, Berwyn, PA, and the Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, PA
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  • George Vamvakias,

    1. From University Dermatology Consultants, Cincinnati, OH, The Savin Center, New Haven, CT, Dermik Laboratories, Berwyn, PA, and the Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, PA
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  • Sharon Levy MD,

    1. From University Dermatology Consultants, Cincinnati, OH, The Savin Center, New Haven, CT, Dermik Laboratories, Berwyn, PA, and the Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, PA
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  • James Leyden MD

    1. From University Dermatology Consultants, Cincinnati, OH, The Savin Center, New Haven, CT, Dermik Laboratories, Berwyn, PA, and the Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, PA
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  • This study was supported by Dermik Laboratories, a division of Aventis Pharmaceuticals Inc, Berwyn, PA

Debra Breneman, md 234 Goodman Street Mail location 523 Cincinnati OH 45267 USA E-mail: bergervr@ucmail.uc.edu

Abstract

Background  Systemic antibiotics such as tetracycline are well accepted as effective in treating the inflammatory papular/pustular phase of rosacea but may be associated with systemic side-effects. Few controlled data on the use of topical antibiotics in rosacea are available.

Objective  We evaluated the efficacy and tolerability of a fixed combination of 5% benzoyl peroxide and 1% clindamycin in a topical gel for the treatment of rosacea.

Methods  This was a 12-week, double-blind, vehicle-controlled, randomized, prospective, parallel-group study in 53 patients with moderate to severe rosacea.

Results  The mean percentage reduction in papules and pustules from baseline to the end of treatment was 71.3% in the benzoyl peroxide/clindamycin group (n = 26) and 19.3% in the vehicle group (n = 26; P = 0.0056). A significant (P = 0.0141) difference in favor of benzoyl peroxide/clindamycin was evident by the third week of treatment. Severity scores for erythema, papules/pustules, and flushing/blushing decreased more with benzoyl peroxide/clindamycin than with vehicle. Overall rosacea severity, Physician Global Assessment, and Patient's Global Assessment at the end of treatment were all significantly improved with benzoyl peroxide/clindamycin compared with vehicle (P = 0.0101, 0.0026, and 0.0002, respectively). Application site reactions were reported in four patients (14.8%) in the benzoyl peroxide/clindamycin group.

Conclusion  A once-daily topical application of a combination of 5% benzoyl peroxide and 1% clindamycin is effective and well tolerated in patients with moderate to severe rosacea.

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