跳至主要内容
临床试验/NCT02995057
NCT02995057已完成不适用

Safety Demonstration of Microneedle Insertion

University of British Columbia1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Skin reaction as measured by a contact dermatitis classification system

研究概览

简要总结

Hypodermic needles are conventionally used to deliver drugs and vaccines into the muscle of humans and animals. Side effects of these needle injections are pain, bleeding, and anxiety in patients. An alternative drug and vaccine delivery method is the use of hollow microneedles, which are sub-millimeter needle-like structures. Microneedles are pain- and bleeding-free, as they do not reach the nerve-endings and blood capillaries in the skin. As a result, they are better received by patients and do not induce needle anxiety. As the investigators' microneedles are made of gold- or silver-coated, as well as uncoated nickel, the purpose of this study is to observe their biocompatibility and inertness.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Proven nickel allergy

排除标准

  • Pregnancy

结局指标

主要结局

Skin reaction as measured by a contact dermatitis classification system

时间窗: 7 days

Allergic patch-test based grading will be done according to the Wilkinson DS et al 1970 reference.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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