Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Picato® Gel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 1,324
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This study is a mandatory post launch observational study in South Korea of 3.000 patients receiving treatment for the first time with a new medicinal product, ingenol mebutate gel (Picato®), approved for topical treatment of actinic keratosis.
Each patient is observed for 8 weeks after treatment completion.
详细描述
Picato® (ingenol mebutate) gel is a new topical therapy for Actinic Keratosis (AK) in adults which was approved by the Korean Ministry of Food and Drug Safety (MFDS) in December 2013. For AK in face or scalp the 0.015 percent gel is approved to be applied once a day for 3 consecutive days, and for AK in trunk or extremities the 0.05 percent gel is approved to be applied once a day for 2 consecutive days.
The re-examination period for Picato® runs from December 2013 to December 2019, during which at least 3,000 patients who are prescribed ingenol mebutate gel for the first time by investigator's medical judgment must be documented in a standard Post Marketing Surveillance (PMS) study.
Each patient is to be observed for 8 weeks following application of ingenol mebutate gel. If a patient is unable to visit the PMS site, the investigator may contact the patient by phone to assess the safety.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient with AK First time treatment with ingenol mebutate 0.015 or 0.05 percent gel
排除标准
- •Children and adolescents
研究组 & 干预措施
Ingenol mebutate treatment cohort
Patients who are prescribed ingenol mebutate gel for the first time by investigator's medical judgment.
干预措施: Ingenol mebutate 0.015 percent or 0.05 percent gel (Drug)
结局指标
主要结局
Adverse Events
时间窗: 8 weeks after treatment completion
According to Korean definition and classification, covering serious as well as non-serious Adverse Events, related as well as non-related to ingenol mebutate treatment
Overall improvement
时间窗: 8 weeks after treatment completion
Graded by investigator on a 3-point scale ('improved', 'no change', 'worsened'), based on number of AK lesions in treated area compared to baseline
次要结局
- Complete clearance rate - Change in AK lesions count: Percentage (%) change in the total number of AK lesions compared to baseline*(8 weeks after treatment)
- Partial clearance rate(8 weeks after treatment)
- Change in AK lesion count(8 weeks after treatment)