NCT00427050已完成2 期
An Open-label, Multi-centre, Dose-escalation, Cohort Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel When Applied to a 25 cm2 Contiguous Actinic Keratoses Treatment Area on the Face or Face and Scalp.
Peplin9 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2007年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- Optimal tolerated regime of PEP005 Topical Gel in patients, when administered as either two day or three day application schedules to a 25 cm2 contiguous AK treatment area on the face or face and scalp
研究概览
简要总结
The purpose of this study is to determine the optimal tolerated regime of PEP005 for the treatment of actinic keratoses of the face or face and scalp.
详细描述
Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Male patients at least 18 years of age.
- •Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.
- •Four to eight clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or face and scalp.
- •5. Ability to follow study instructions and likely to complete all study requirements.
- •6. Written informed consent has been obtained.
- •Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study data package.
排除标准
- 未提供
结局指标
主要结局
Optimal tolerated regime of PEP005 Topical Gel in patients, when administered as either two day or three day application schedules to a 25 cm2 contiguous AK treatment area on the face or face and scalp
次要结局
- Efficacy at 2 or 3day application PEP005 Topical Gel at the MTD of 0.025% in the Expanded Cohort, and at 2 lower concs of 0.0175% and 0.0125% at either a 2 or 3day application, when applied to 25cm2 AK treatment area on face or face/scalp.
研究者
研究点 (9)
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