NCT00915551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, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIb)
Peplin21 个研究点 分布在 2 个国家目标入组 278 人开始时间: 2009年6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
- 278
- 试验地点
- 21
- 主要终点
- Complete Clearance of Actinic Keratoses (AK) Lesions
研究概览
简要总结
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.
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
- •Patient is male or female and at least 18 years of age
- •Female patients must be of either:
- •Non-childbearing potential, post-menopausal
- •Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy
排除标准
- •Cosmetic or therapeutic procedures within 2 weeks and 2cm 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 the selected treatment area
研究组 & 干预措施
PEP005 (Ingenol Mebutate) gel
Experimental
干预措施: PEP005 (Ingenol Mebutate) gel, 0.015% (Drug)
Vehicle gel
Placebo Comparator
干预措施: Vehicle Gel (Drug)
结局指标
主要结局
Complete Clearance of Actinic Keratoses (AK) Lesions
时间窗: baseline and 57 days
Complete clearance of the treatment field
次要结局
- Partial Clearance of Actinic Keratoses (AK)(baseline and 57 days)
研究者
研究点 (21)
Loading locations...
相似试验
已完成
3 期
A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)Actinic KeratosisNCT00916006Peplin269
已完成
2 期
Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.015%, in Patients With Photo-damaged SkinPhoto-damageNCT01214577Peplin24
已完成
3 期
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head LocationsActinic KeratosesNCT00942604Peplin203
已完成
3 期
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head LocationsActinic KeratosesNCT00742391Peplin255
已完成
2 期
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic KeratosesActinic KeratosisNCT00107965Peplin60