Cutis · 2006
The results of the MORE trial: overview.
Клиническое исследование IV фазыСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Campbell James L, Weiss Jonathan S
Аннотация
Successful treatment of acne requires knowledge of the performance capabilities of available treatments and patient expectations. The Measuring Acne Outcomes in a Real-World Experience (MORE) trial was a prospective, open-label, multicenter, observational, phase 4 study of the effectiveness and safety of adapalene gel 0.1% when used with other acne treatments, either as part of an initial combination regimen or as add-on therapy. The MORE trial also surveyed subjects regarding their satisfaction with treatment and their rating of adapalene gel 0.1% versus acne treatments they had previously used. Enrollment consisted of 1979 subjects aged 12 years or older; 1662 subjects completed the week 12 assessment, using adapalene gel 0.1% once daily for 12 weeks according to protocol. Significant reductions in the number of acne lesions were seen as early as week 6 and were even more pronounced by week 12 (P <. 001 vs baseline for all lesion types at both weeks 6 and 12). Adverse events were uncommon (5.8% of subjects) and were generally mild, with the most common being skin or subcutaneous tissue disorders. Adherence to therapy was high for both the initial combination and add-on therapies. Subjects expressed a high degree of satisfaction with and preference for adapalene gel 0.1% over previous treatments. The MORE trial corroborates the general consensus regarding the efficacy of combination therapy including a topical retinoid and demonstrates that adapalene gel 0.1% is effective, well tolerated, and likely to enhance adherence to treatment.