Efficacy of Epiduo and Adherence of Patients Between 12 to 20 Years Using This Drug First Time in the Monotherapy of Moderate Inflammatory Acne
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,113
- 主要终点
- Severity of acne
研究概览
简要总结
The purpose of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy.
详细描述
The objective of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy. This non-interventional trial will include a larger population of teenaged acne patients in order to establish the practical contribution of a new mini-questionnaire to the evaluation of adherence for the physician in the daily clinical practice in general and in young adults topically treated with Epiduo in particular. In addition safety and local tolerability profile of Epiduo are to be assessed under marketed conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has been diagnosed with moderate inflammatory acne
- •Topical monotherapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study
- •The patient is aged between 12 and 20 years
排除标准
- •Pregnancy or breastfeeding
- •Hypersensitivity to the medication or any of the ingredients
- •Other contraindications mentioned in the Epiduo SPC
结局指标
主要结局
Severity of acne
时间窗: at baseline and after 12 weeks of treatment
efficacy is assessed by change in severity of acne according to the Leeds revised acne grading system
次要结局
- local skin irritations(over 12 weeks)
- treatment adherence(at final examination after 12 weeks of treatment)