Within-tester Repeatability and Between-tester Reproducibility of Skin Test Endpoint Titration
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
Don Cockcroft
Professor, College of Medicine
University of Saskatchewan
