NCT01302925已完成1 期
PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate 0.05% and 0.015% Gel Followed by Hand Washing in Healthy Subjects.
Peplin1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年2月最近更新:
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
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Local Skin Responses
研究概览
简要总结
The purpose of this phase 1 trial is to investigate the local tolerability on the finger following exposure to PEP005 Gel 0.015% or 0.05% and hand washing once daily, for 2 or 3 consecutive days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Must be male or female and at least 18 years of age
- •Female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception
- •Ability to provide informed consent
排除标准
- •Have received treatment with immunomodulators, or interferon/interferon inducers or systematic medications that suppress the immune system in the last 4 weeks
- •Exposed to prescribed systemic (take as tablet, injection etc) or topical (gel, cream, lotion) medication within the last 7 days
- •Have any signs of skin irritation or damaged skin at or around the dominant index finger
- •Have worked in an occupation with a high risk of being in contact with irritative material (eg. chemicals, painting) on their hands, especially fingers
- •Those who are currently participating in any other clinical trial
- •Those known or suspected of not being able to comply with the requirements of the protocol
- •Females who are pregnant or are breastfeeding
研究组 & 干预措施
PEP005 Gel 0.05%/2 days
Experimental
Subjects will be exposed to investigational product for 2 consecutive days.
干预措施: PEP005 Gel (Drug)
PEP005 Gel 0.015%/3 days
Experimental
Subjects will be exposed to investigational product for 3 consecutive days.
干预措施: PEP005 Gel (Drug)
结局指标
主要结局
Local Skin Responses
时间窗: Up to 8 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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