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临床试验/NCT03489694
NCT03489694已完成不适用

Within-tester Repeatability and Between-tester Reproducibility of Skin Test Endpoint Titration

University of Saskatchewan1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Within-tester repeatability

研究概览

简要总结

This study will examine the within-tester repeatability and between-tester reproducibility of skin test endpoint titrations performed in those with allergic sensitivities.

详细描述

Participants will be recruited from the local community. Participants with a previous history of skin prick testing in our lab will not be required to undergo preliminary skin prick testing, as the allergen to be used for skin prick titrations is known. New participants will undergo skin prick testing. The procedures for skin prick testing and skin test endpoint (STE) titration will be guided by the AllerGen CIC Allergen Skin Titration by Epicutaneous Method (Prick) Standard Operating Procedure. Different allergen extracts for the skin prick test or different doubling doses of an allergen in duplicate for the STE will be applied to the forearm, pricked with a lancet, and assessed ten minutes later by measuring the wheal sizes produced. The study will require three visits to the lab (i.e. three testers), each separated by one week and lasting roughly 30 minutes. Each visit will entail the duplicate STE procedure performed by a different tester. If a participant is new to the lab, they will undergo skin prick testing during their first lab visit prior to undergoing the skin prick titration and so, their first study visit may last up to one hour.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •must have allergic sensitivities confirmed by a skin prick test (or historically) to at least one of the study allergens

排除标准

  • •skin condition on the forearms
  • •if there is a situation where interpretation of skin reactions would be difficult (e.g. sleeve tattoos, scarring)
  • •regular use of anti-histamines (assessed on a case-by-case basis)

结局指标

主要结局

Within-tester repeatability

时间窗: 10 minutes post skin pricking

Comparison of wheal size (in mm) of skin reactions caused by a tester (duplicate skin pricking for each concentration of allergen administered)

Between-tester reproducibility

时间窗: approximately 3 weeks (one week washout between tests)

Comparison of wheal size (in mm) of skin reactions caused by three different testers

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

Don Cockcroft

Professor, College of Medicine

University of Saskatchewan

研究点 (1)

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