Epiduo in the Long-term Treatment of Moderate to Severe Acne With or Without Concomitant Medication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,036
- 主要终点
- Severity of acne
研究概览
简要总结
This observational study is designed to assess the long-term efficacy and safety of Epiduo (alone or in combination with other drugs) under daily clinical practice conditions in patients with moderate to severe inflammatory acne. In addition, the effect of Epiduo on quality of life and patient adherence will be assessed under marketed conditions.
详细描述
This observational study is designed to assess the long-term efficacy and safety of Epiduo under daily clinical practice conditions. The study includes patients of all ages with moderate to severe inflammatory acne, taking Epiduo alone or in combination with other drugs. In addition, the effect of Epiduo alone or in combination with other drugs on quality of life and patient adherence will be assessed under marketed conditions.
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 be 9 months. An interim and final examination with subsequent documentation are designated to be performed about 3 and 9 months after the start of treatment, respectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has been diagnosed with moderate to severe inflammatory acne (Leeds Grade 4-12)
- •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
- •Use of Epiduo within 3 months prior to inclusion
- •Pregnancy or breastfeeding
- •Acne inversa
- •Acne with preferential manifestation of microcysts, macrocysts and macrocomedones
- •Hypersensitivity to the drug or any of its ingredients
- •If applicable, other restrictions outlined in the SPC of Epiduo
结局指标
主要结局
Severity of acne
时间窗: at baseline and after 3 and 9 months treatment
Efficacy is assessed by change in severity of acne according to the Leeds revised grading system
次要结局
- Quality of Life(at baseline and after 3 and 9 months of treatment)
- Treatment adherence(after 3 and 9 months of treatment)
- Local Skin Irritations(over 9 months)