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临床试验/NCT05313555
NCT05313555终止不适用

The Effect of Violet Device Dosed UV-C Exposure on Healthy Hand Skin

University of Michigan2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2022年4月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
23
试验地点
2
主要终点
Deoxyribonucleic acid (DNA) damage in the form of DNA base pair dimers measured by immunohistochemistry microscopy with statistical analysis.

研究概览

简要总结

The purpose of this trial is to determine the safety of ultraviolet light (UV-C) irradiation as a method to sanitize hands instead of chemical-based sanitizers.

Eligible participants will be enrolled and receive treatment with the Violet UV-C device or UV-B. Punch biopsies will be performed following UV exposure to quantify any changes in cellular and molecular properties of the tissue.

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
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Good general health
  • Type 1 or type 2 skin (lightly colored skin)
  • No history of skin disorders, disease states or physical conditions which would impair evaluation of the test sites
  • Willingness and ability to follow the protocol
  • No use of lotion or hand sanitizer 3 hours before the experiment

排除标准

  • Has received an experimental drug or used an experimental device in the 30 days prior to admission to the study
  • Undergoing treatment or taking medication that increases sun sensitivity
  • History of keloids
  • History of sensitivity to lidocaine or epinephrine
  • Pregnant or nursing women, pregnancy status will be self-reported, women unsure of their pregnancy status will be excluded

研究组 & 干预措施

Ultraviolet lights (UV-B)

Active Comparator

干预措施: Ultraviolet Light (UV-B) (Device)

结局指标

主要结局

Deoxyribonucleic acid (DNA) damage in the form of DNA base pair dimers measured by immunohistochemistry microscopy with statistical analysis.

时间窗: Day 1 (visit 1 after light therapy)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gary Fisher

Professor

University of Michigan

研究点 (2)

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