Incidence of Squamous Cell Carcinoma and Other Skin Neoplasia in Subjects With Actinic Keratosis Treated With Ingenol Disoxate Gel 0.018% or 0.037%, or Vehicle Gel
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- LEO Pharma
- 入组人数
- 563
- 试验地点
- 31
- 主要终点
- Time to First Squamous Cell Carcinoma (SCC) in the Treatment Area
研究概览
简要总结
One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of progression of AK to squamous cell carcinoma (SCC). This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk, but since patients can have dozens of AKs and the disease is chronic the cumulative risk for a patient can be substantial.
In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients over a period of 2 years, so that the total follow-up time for each patient will be 3 years and 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent has been obtained.
- •The subject has been treated in one of the trials LP0084-1193, -1194, -1195, or -1196 and has been evaluated at the end of follow-up visit (month 14) of that trial.
排除标准
- •The subject is in need of treatment with ingenol mebutate or ingenol disoxate in the selected treatment area .
- •The subject is enrolled in any other interventional clinical trial.
- •For subjects where there is a gap between end of follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196 and participation in the current trial:
- •The subject has been treated with ingenol mebutate or ingenol disoxate in the selected treatment area after end of follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196 and until participation in the current trial.
- •The subject has been enrolled in any other interventional clinical trial after end of follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196 and until participation in the current trial.
研究组 & 干预措施
Ingenol disoxate gel 0.018%
干预措施: ingenol disoxate gel 0.018% (Drug)
Ingenol disoxate gel 0.037%
干预措施: ingenol disoxate gel 0.037% (Drug)
Vehicle gel
干预措施: Vehicle gel (Other)
结局指标
主要结局
Time to First Squamous Cell Carcinoma (SCC) in the Treatment Area
时间窗: From Visit 2 (6 months after Month 14 of main trial) to first SCC in the treatment area, up to 24 months
Time to first squamous cell carcinoma (SCC) in the treatment area. Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio. The indicated measured values are the observed incidence rates of the SCC in the treatment area which form the basis of the statistical analysis of the time to event analysis
次要结局
- Time to First Squamous Cell Carcinoma (SCC) or Other Skin Neoplasia in the Treatment Area(From Visit 2 (6 months after Month 14 of main trial) to first SCC or other skin neoplasia in the treatment area, up to 24 months)