期刊
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
卷 59, 期 5, 页码 792-800出版社
MOSBY-ELSEVIER
DOI: 10.1016/j.jaad.2008.06.040
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资金
- Arcutis Pharmaceuticals
- Allergan Inc
- Arcutis Inc
- Dusa Inc
- Galderma Inc
- Stiefel Inc
- QLT Inc
- Medicis Inc
- Aventis Inc
- Sanofi Aventis Inc
- Ortho Inc
- Coria Inc
- Cutanea Inc
Objective: We sought to evaluate efficacy, safety, and tolerability of a combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BPO 2.5%) aqueous gel in moderate to severe acne vulgaris. Methods: A total of 2813 patients, aged 12 years or older, were randomized to receive clindamycin-BPO 2.5%, individual active ingredients, or vehicle in two identical, double-blind, controlled 12-week, 4-arm studies evaluating safety and efficacy (inflammatory and noninflammatory lesion counts) using Evaluator Global Severity Score and subject self-assessment. Results: Clindamycin-BPO 2.5% demonstrated statistical superiority to individual active ingredients and vehicle in reducing both inflammatory and noninflammatory lesions and acne severity. Visibly greater improvement was observed by patients with clindamycin-BPO 2.5% as early as week 2. No substantive differences were seen in cutaneous tolerability among treatment groups and less than 1% of patients discontinued treatment because of adverse events. Limitations: Data from controlled studies may differ from clinical practice. Conclusions: Clindamycin-BPO 2.5% provides statistically significant greater efficacy than individual active ingredients and vehicle with a highly favorable safety and tolerability profile. (J Am Acad Dermatol 2008;59:792-800.)
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