Adaptive Deployment of DermAI to Evaluate Human Factor of Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Classification of Test Site Region Reaction
研究概览
简要总结
The purpose of this research is to improve how well remote patch allergy testing works and make sure they are easy and practical for people to use from home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Willing and able to provide informed consent.
排除标准
- •Has used topical or oral steroids two weeks prior to patch testing.
- •Currently taking immunosuppression agents or is immunocompromised due to medical condition.
- •No sunburn or rash at site of testing.
- •Women who are breastfeeding or pregnant.
- •Treatment with ultraviolet (UV) light (including tanning) during the two weeks prior to visit.
- •Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting patch test area from excess moisture due to showering).
研究组 & 干预措施
DermAI and Patch Allergen Testing
Subjects will have two allergen patches on their forearms for 48 hours. After 48 hours, the patches will be removed and a photograph will be taken where the patches were placed. This photograph will undergo interpretation by a medical professional and by the AI algorithm (DermAI) to evaluate for positive allergic reactions.
干预措施: AI algorithm to evaluate photographs of skin test patch regions (Device)
DermAI and Patch Allergen Testing
Subjects will have two allergen patches on their forearms for 48 hours. After 48 hours, the patches will be removed and a photograph will be taken where the patches were placed. This photograph will undergo interpretation by a medical professional and by the AI algorithm (DermAI) to evaluate for positive allergic reactions.
干预措施: Allergen Patch (Device)
结局指标
主要结局
Classification of Test Site Region Reaction
时间窗: 1 week
Number of skin patch interpretations using novel AI algorithms analysis to be in concordant with human review interpretation for the classification of regions within the test panel that either were a reaction (reaction grade 1+) or no reaction (grade 0).
次要结局
- False Positive Rate(1 week)
- False Negative Rate(1 week)
- Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 0(1 week)
- Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 1(1 week)
- Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 2(1 week)
- Early Termination of Testing(1 week)
- Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 3(1 week)
- False Positive Rate(1 week)
- Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 4(1 week)
- False Negative Rate(1 week)
- Participants That Removed Patches Early(1 week)
- Adverse Events Related to Allergen Exposure(1 week)