Validation and Reproducibility of Type I Hypersensitivity Reaction in the Diagnostic Process of the Skin Prick Test in Allergic and Non-allergic Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hippocreates
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Within-test agreement (% of patients with consistent results) of wheal positivity per allergen between manual and automated test.
研究概览
简要总结
To improve accuracy and take out human error opportunities, Hippo Dx developed S.P.A.T., an automated skin prick test. This study will provide a comparison between manual and automated skin prick test in allergic and non-allergic individuals with a panel of common inhalant allergens.
The primary endpoint is to compare the accuracy of S.P.A.T. to detect sensitization to common aeroallergens compared to a manual skin prick test (SPT).
It is a prospective monocentric study that will include 120 study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (18-65y) with presence or absence of self-reported symptoms of inhalant allergy will be included.
排除标准
- •Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment
- •Use of antihistaminic medication < 7 days before the start of the study
- •Use of tricyclic antidepressants (antihistamine activity) < 7 days before the start of the study
- •Use of topical corticoids on the forearm < 7 days before the start of the study
- •Use of Omalizumab < 6 months before the start of the study
- •Pregnancy: there is a remote possibility of inducing a systemic allergic reaction that could induce uterine contractions or necessitate the use of epinephrine (thought to cause constriction of the umbilical artery)
结局指标
主要结局
Within-test agreement (% of patients with consistent results) of wheal positivity per allergen between manual and automated test.
时间窗: 15 minutes after the diagnostic test
Each of the allergens are pricked three times via manual and automated skin prick test. Three positive or negative test results are considered consistent whereas either one or two positive or negative test results are considered non-consistent resulting in an inconclusive test result.
次要结局
- Amount of allergen solution that is required to run an automated versus a manual skin prick test.(during the diagnostic test)
- Allergy symptoms assessed by visual analogue scale between patients with a positive versus negative test result.(day of the diagnostic test)
- Time (seconds) required to run an automated versus a manual skin prick test.(during the diagnostic test)
- Level of discomfort experienced by the patient as assessed by visual analogue scale after an automated versus a manual skin prick test.(15 minutes after the diagnostic test)