NCT02090465已完成不适用
Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate (Picato) in a Period of 8 Weeks.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- Actinic keratosis
研究概览
简要总结
Assessment of treatment success and quality of life in patients with actinic keratoses under therapy with Ingenol Mebutate (Picato) in a period of 8 weeks.
详细描述
Non-interventional (observational) study (NIS), non-controlled, prospective cohort study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-hyperkeratotic, non-hypertrophic actinic keratoses where treatment with Picato® is indicated and the treatment is intended by physicians.
排除标准
- •Preceding use of Picato® on the area planned for treatment
- •Any other specific local treatment of actinic keratoses on the area planned for treatment during the last 8 weeks
- •Melanoma, squamous cell carcinoma or spinalioma on the area planned for treatment
- •Open wounds on the area planned for treatment
- •Contraindications according to prescribing information
研究组 & 干预措施
all eligible patients
Treatment with Picato according to Summary of Product Characteristics (SmPC)
干预措施: Ingenol Mebutate (Drug)
结局指标
主要结局
Actinic keratosis
时间窗: 8 weeks
Documentation of the course of actinic keratoses and skin findings during ambulant routine use of Picato®
Skindex-16
时间窗: 8 weeks
Patient' s quality of life during ambulant routine use of Picato®
Dosage of Picato®
时间窗: 8 weeks
Prescribed and applied dosages and adherence during ambulant routine use of Picato®
次要结局
未报告次要终点
研究者
研究点 (1)
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