NCT01892137已完成1 期
Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 137
- 试验地点
- 10
- 主要终点
- Clearance of AK
研究概览
简要总结
The main purpose of this trial is to demonstrate the predictive value of the clinical diagnosis of clearance of Actinic Keratoses after treatment with Ingenol Mebutate using histopathological examination as the standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Must be male or female and at least 18 years of age.
- •Female patients must be on non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception
- •Ability to provide informed consent
- •Subjects must have 5-9 clinically typical, visible and discrete AK lesions within a contiguous 25cm2 treatment area on the trunk and extremities except the back of the hand
- •AK should be confirmed by histopathology of one of the AK's prior to inclusion
排除标准
- •location of the selected treatment area within 5cm of an incompletely healed wound or within 10cm of a suspected basal cell carcinoma or squamous cell carcinoma
- •undergone Cosmetic or therapeutic procedures
- •use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 1
- •use of topical creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit
- •treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of visit 1
- •treatment with 5-FU, imiquimod, diclofenac, ingenol mebutate of photodynamic therapy within 2cm of the treatment area in the 8 weeks prior to visit 1
- •use of systemic retinoids
- •those who are currently participating in any other interventional clinical trial
- •females who are pregnant or are breastfeeding
- •those known or suspected of not being able to comply with the requirements of the protocol or provide consent
研究组 & 干预措施
Open label active
Other
干预措施: Ingenol mebutate gel 0.05% (Drug)
结局指标
主要结局
Clearance of AK
时间窗: 8 weeks
The primary response criterion is the clinical and histological clearance of AK at Day 57. Clinical Clearance will be measured by counting AKs, and histological clearance will be by performing a biopsy (result reported as AK or not AK).
次要结局
- Complete clearance of AKs in the Selected Treatment Area(8 weeks)
研究者
研究点 (10)
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