Application of Epiduo(R) PUMP in Daily Practice in Patients With Inflammatory Acne
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,388
- 主要终点
- Severity of acne
研究概览
简要总结
The purpose of this observational trial is to assess application and convenience of Epiduo® PUMP under daily clinical practice conditions in patients with moderate to severe inflammatory acne.
详细描述
The objective of this observational trial is to assess application and convenience of Epiduo® PUMP under daily clinical practice conditions in patients with moderate to severe inflammatory acne using this drug in topical monotherapy or in combination with other drugs. In addition, efficacy of Epiduo® and incidence of adverse events will be assessed under marketed conditions. Also, patients' body beliefs will be recorded using the dysmorphic concern questionnaire.
The observational study is designed as a multicentre study, covering all parts of Germany. Participating investigators are dermatologists with an adequate patient pool of acne patients. The observation time per patient will up to 3 months.
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
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥9 years
- •The patient has been diagnosed with moderate to severe inflammatory acne (Leeds Grade 4-12)
- •Chest/back affected allowed, but not required
- •Topical therapy of acne with Epiduo® is indicated, the decision about treating the patient with Epiduo® has been made independently from this study
排除标准
- •Pregnancy or breastfeeding
- •Acne inversa
- •Acne with preferential manisfestation of microcysts, macrocysts and macrocomedones
- •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 up to 3 weeks of treatment
Efficacy is assessed by change in severity of acne according to the Leeds revised grading system
次要结局
- Physician's assessment(at follow-up)
- Adherence(at follow-up)
- Adverse drug reactions(at follow-up)
- Patient-reported assessment(at follow-up)
- Dysmorphic concern(at baseline)