Anesthetic Effect Duration Produced by Lidocaine 7% + Tetracaine 7% Cream on 2 Different Body Areas
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Duration of Anesthesia(Minutes)
研究概览
简要总结
The purpose of this study is to evaluate the duration of anesthetic effect produced , Lidocaine7% + Tetracaine 7% cream when applied with 2 different application times on the face and thigh.
详细描述
Subjects will have 4 target zones defined; 2 on the face and 2 on the anterior thighs. Upon inclusion into the study, subjects will have the study drug applied with a different application time to one side of the face and anterior thigh according to the randomization. After the completion of the application process, study drug on both sides of the face and on both anterior thighs will be removed by peeling.
After drug removal, the duration of anesthetic effect of the study drug will be tested using a pinprick test. Five (5) pinpricks using a 21-gauge needle will be performed at the 4 target zones (each side of the face and both anterior thighs). The pinprick test will be repeated up to 8 hours after drug removal. There will be a total of 20 post drug removal pinprick test completed.
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
- 是
入选标准
- •Healthy male of female subjects aged 18 or older with a normal not excessive hairy skin,
排除标准
- •Female subjects who are pregnant or breast-feeding; or plan to become pregnant,
- •Subjects who have a known allergy to one of the components of the test drug lidocaine, tetracaine or other local anesthetics,
- •Subjects who are at risk in terms of precautions, warnings, and contra-indication with the study product.
研究组 & 干预措施
lidocaine 7% and tetracaine 7%
干预措施: Lidocaine 7% + Tetracaine 7% cream (Drug)
结局指标
主要结局
Duration of Anesthesia(Minutes)
时间窗: From T0 (product removal) up to T8 hours after product removal
Onset and end of anesthesia are evaluated by Pinprick tests. Duration of anesthesia is calculated as: difference between onset and end of anesthesia (minutes).
次要结局
- Adverse Events(During the study)