NCT00742391已完成3 期
A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05% In Patients With Actinic Keratoses ON Non-head Locations (REGION-I)
Peplin20 个研究点 分布在 2 个国家目标入组 255 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 255
- 试验地点
- 20
- 主要终点
- Patients With Complete Clearance of Actinic Keratosis (AKs)
研究概览
简要总结
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
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
- Triple (Participant, Care Provider, Investigator)
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 of:
- •Non-childbearing potential;
- •Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception.
- •4 to 8 AK lesions on non-head locations.
排除标准
- •Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.
- •Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks.
- •Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 8 weeks and 2 cm of treatment area
研究组 & 干预措施
1
Active Comparator
PEP005 (ingenol mebutate) Gel
干预措施: PEP005 (ingenol mebutate) Gel (Drug)
2
Placebo Comparator
Vehicle gel
干预措施: Vehicle gel (Drug)
结局指标
主要结局
Patients With Complete Clearance of Actinic Keratosis (AKs)
时间窗: 57 days
Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.
次要结局
- Patients With Partial Clearance of Actinic Keratosis (AKs)(baseline and 57 days)
研究者
研究点 (20)
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