An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 3.75% for the once-daily treatment of moderate to severe acne vulgaris

David M. Pariser, Phoebe Rich, Fran E. Cook-Bolden, Andrew Korotzer

Research output: Contribution to journalArticle

29 Scopus citations


Objective: To evaluate efficacy, safety, and tolerability of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 3.75% (clindamycin-BP 3.75%) aqueous gel in moderate to severe acne vulgaris. Methods: A total of 498 patients, 12-40 years of age, were randomized to receive clindamycin-BP 3.75% or vehicle in a double-blind, controlled 12-week, 2-arm study evaluating safety and efficacy using inflammatory and noninflammatory lesion counts, Evaluator Global Severity Scores (EGSS) and subject self-assessment (SSA). In addition, patients completed a patient satisfaction survey (PSS), acne-specific QoL questionnaire, and assessed their facial skin for shininess/oiliness. Results: Clindamycin-BP 3.75% demonstrated statistical superiority to vehicle in reducing both inflammatory and noninflammatory lesions and acne severity. Clindamycin-BP 3.75% showed greater efficacy relative to vehicle in assessments of skin oiliness, SSA and PSS. No substantive differences were seen in cutaneous tolerability among treatment groups and no patients discontinued treatment with Clindamycm-BP 3.75% because of adverse events. Limitations: Data from controlled studies may differ from clinical practice. It is not possible to determine the contributions from the individual active ingredients. Conclusions: Clindamycin-BP 3.75% provides statistically significant greater efficacy than vehicle with a favorable safety and tolerability profile.

Original languageEnglish (US)
Pages (from-to)1083-1089
Number of pages7
JournalJournal of Drugs in Dermatology
Issue number9
StatePublished - Sep 1 2014


ASJC Scopus subject areas

  • Dermatology

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