Drug Information for Clindamycin Phosphate and Benzoyl Peroxide (Mylan Pharmaceuticals Inc.): CLINICAL STUDIES

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  • In two adequate and well controlled clinical studies of 758 patients, 214 used Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5%, 210 used benzoyl peroxide, 168 used clindamycin, and 166 used vehicle. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% applied twice daily for 10 weeks was significantly more effective than vehicle in the treatment of moderate to moderately severe facial acne vulgaris. Patients were evaluated and acne lesions counted at each clinical visit; weeks 2, 4, 6, 8 and 10. The primary efficacy measures were the lesion counts and the investigator’s global assessment evaluated at week 10. Patients were instructed to wash the face with a mild soap, using only the hands. Fifteen minutes after the face was thoroughly dry, application was made to the entire face. Non-medicated make-up could be applied at one hour after the Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% application. If a moisturizer was required, the patients were provided a moisturizer to be used as needed. Patients were instructed to avoid sun exposure. Percent reductions in lesion counts after treatment for 10 weeks in these two studies are shown below:

    Study 1
    Clindamycin Phosphate and Benzoyl Peroxide Gel,1%/5%n = 120Benzoyl peroxiden = 120Clindamycinn = 120Vehiclen = 120
    Mean percent reduction in inflammatory lesion counts
    46%32%16%+3%
    Mean percent reduction in non-inflammatory lesion counts
    22%22%9%+1%
    Mean percent reduction in total lesion counts
    36%28%15%0.2%
    Study 2
    Clindamycin Phosphate and Benzoyl Peroxide Gel,1%/5%n = 95Benzoyl peroxiden = 95Clindamycinn = 49Vehiclen = 48
    Mean percent reduction in inflammatory lesion counts
    63%53%45%42%
    Mean percent reduction in non-inflammatory lesion counts
    54%50%39%36%
    Mean percent reduction in total lesion counts
    58%52%42%39%

    The Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% group showed greater overall improvement than the benzoyl peroxide, clindamycin and vehicle groups as rated by the investigator.

  • Drug Information Provided by National Library of Medicine (NLM).
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