Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 502
- 试验地点
- 1
- 主要终点
- Complete clearance of all AKs
研究概览
简要总结
This is a phase 4, multi-centre, randomized, two group, open label, active controlled, parallel group, 17 week trial.
详细描述
All subjects who qualify for this trial are to have 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or scalp.
Eligible subjects will be randomised in a 1:1 ratio to the following treatment groups:
- Treatment Group A: Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for the first treatment course. At 8 weeks after treatment initiation, subjects who present with existing AKs or newly emergent AKs in the treatment area will receive one more treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days.
- Treatment Group B: Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures
- •Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp
排除标准
- •Location of the selected treatment area:
- •on the periorbital skin
- •on the perioral skin/around the nostrils
- •within 5 cm of an incompletely healed wound
- •within 10 cm of a suspected BCC or SCC or other neoplasia
研究组 & 干预措施
Treatment Group A
Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for the first treatment course. At 8 weeks after treatment initiation, subjects who present with existing AKs or newly emergent AKs in the treatment area will receive one more treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days.
干预措施: Ingenol Mebutate Gel, 0.015% (Drug)
Treatment Group B
Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.
干预措施: Diclofenac sodium gel 3% (Drug)
结局指标
主要结局
Complete clearance of all AKs
时间窗: 11 Months
Complete clearance of all AKs in the treatment field at Week 8 for ingenol mebutate gel 0.015% and Week 17 for diclofenac sodium gel 3%
次要结局
- Complete clearance of all AKs at Week 17(11 Months)