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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
Author(s) -
Breneman Debra,
Savin Ronald,
VandePol Christine,
Vamvakias George,
Levy Sharon,
Leyden James
Publication year - 2004
Publication title -
international journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.677
H-Index - 93
eISSN - 1365-4632
pISSN - 0011-9059
DOI - 10.1111/j.1365-4632.2004.02283.x
Subject(s) - benzoyl peroxide , medicine , rosacea , clindamycin , dermatology , tolerability , acne , erythema , randomized controlled trial , antibiotics , gastroenterology , surgery , adverse effect , microbiology and biotechnology , chemistry , organic chemistry , polymerization , biology , polymer
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.