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  • Title: Study design and selection criteria in the BEST study.
    Author: Rist T, Davis MW.
    Journal: Cutis; 2003 Feb; 71(2 Suppl):5-9. PubMed ID: 12630669.
    Abstract:
    Patients with acne should receive prompt and effective treatment that satisfies their needs. The combination of benzoyl peroxide/clindamycin has demonstrated efficacy for the treatment of patients with acne vulgaris. The BenzaClin (benzoyl peroxide/clindamycin topical gel) Efficacy and Satisfaction Trial (BEST), a large, open-label, multicenter study, evaluated patient satisfaction in response to 8 weeks of treatment with benzoyl peroxide/clindamycin topical gel in patients with mild to moderate acne who were dissatisfied with their current acne treatment regimen. Patients eligible for the study were at least 12 years of age and had rated satisfaction with their prior acne therapy as low (0-4) on an 11-point visual analog scale (0 = not satisfied to 10 = very satisfied). Patients with clinically significant cardiovascular, pulmonary, renal, or endocrine disease were excluded from this study, as were those with a hypersensitivity to study drug components. Study variables evaluated at baseline and after 8 weeks of treatment with benzoyl peroxide/clindamycin topical gel included patient satisfaction; acne severity, evaluated with the Global Acne Grading System (GAGS); evaluation of the social aspects of living with acne, measured with the Acne Quality of Life (AQOL) scale; and Physician Global Assessment (PGA) of patient response to treatment, measured on a 5-point scale (0 = worse to 4 = marked improvement). This open-label study design allowed for assessment of patient satisfaction in response to treatment in a large patient population (n = 1,389) in a real-world setting.
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