The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice: A Prospective Phase IV, Multicentre, Pan-Hellenic Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Rate of complete clearance
研究概览
简要总结
This is a prospective, non-interventional study of adult patients prescribed topical treatment with ingenol mebutate gel (Picato®) as part of provision of care for the treatment of Non-hyperkeratotic, non-hypertrophic Actinic Keratosis (AK). Patients with complete clearance at 8 weeks will be followed for one year or until retreatment of AK in the area initially treated, whatever comes first. For patients with incomplete clearance in the treated area at 8 weeks the treatment strategy for this area will be recorded but no further follow-up will take place. The effectiveness, tolerability, adherence, patient satisfaction and health-related quality of life (HRQoL) associated with Picato® treatment will be evaluated.
详细描述
Actinic Keratosis (AK) is caused by exposure to UV radiation and has the potential to regress to normal skin or to progress to squamous cell carcinoma. Ingenol mebutate gel is a relatively new topical treatment option for AK in Greece.
Taking into consideration the limited real-world evidence that is attributed to the recent advent of Picato in the Greek market, this non-interventional observational study aims primarily at assessing the characteristics of patients selected for this treatment, the effectiveness and tolerability of the treatment, patient satisfaction and the impact of the therapy on patients' HRQoL in standard clinical practice.The study will be carried out by approximately 30 physicians practicing in private or public hospitals and clinics in representative geographical regions of Greece.
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
- •Planned to receive topical ingenol mebutate gel for treatment of Actinic Keratosis according to current labelling in Greece.
- •Written informed consent obtained to use the patient's data for the study.
排除标准
- •Contraindications according to prescribing information.
- •Previous treatment with PICATO in the selected treatment area.
研究组 & 干预措施
Ingenol mebutate gel 0.015 percent
Topical treatment of face or scalp once daily for three consecutive days
干预措施: Ingenol mebutate (Drug)
Ingenol mebutate gel 0.05 percent
Topical treatment of trunk or extremities once daily for two consecutive days
干预措施: Ingenol mebutate (Drug)
结局指标
主要结局
Rate of complete clearance
时间窗: Around 8 weeks post treatment
Percentage of patients with no clinically visible remaining lesions in treated area
Lesion count reduction
时间窗: Around 8 weeks post treatment
Reduction in number of clinically visible lesions in treated area compared to baseline count.
次要结局
- Remission rate for patients with complete initial clearance(12 months)
- Health Related Quality of Life EQ-5D-5L(Baseline and around 8 weeks post treatment)
- Patient satisfaction with treatment(Around 8 weeks post treatment)