跳至主要内容
临床试验/NCT05339750
NCT05339750已完成不适用

Democratization of Allergy Skin Patch Testing to Increase Efficiency and Scale of the Practice

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 233 人开始时间: 2022年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
233
试验地点
1
主要终点
AI algorithms predictions of reactions

研究概览

简要总结

The purpose of this research is to assess human and artificial intelligence performance in grading contact dermatitis reactions in healthy volunteers.

详细描述

Study participation involves three visits to the study site on Days 1, 3, and 5, and completion of a demographics and allergy history questionnaire. Researchers will review medical history and current medications. On Day 1 a patch will be applied with 10 allergens and a routine skin examination will be conducted and a photograph will be taken of the forearm. On day 3, subjects will return to remove the patch test and have photographs of the area taken. On day 5, the final assessment for allergic contact dermatitis will be performed and photographs of the area taken.

Key Information: The most common side effect of skin testing is slightly swollen, red, itchy bumps (wheals). These wheals may be most noticeable during the test. In some, an area of swelling, redness and itching may develop a few hours after the test and remain for a couple of days. Rarely, allergy skin tests can produce a severe, immediate allergic reaction. The patches are worn on the forearm for 48 hours. During this time, bathing and activities that cause heavy sweating should be avoided. Irritated skin at the patch site may indicate an allergy. If a positive test result is documented, a medical professional will provide education and recommend follow up with primary care provider.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

  • •Adults over the age of 18
  • •Willing and able to provide informed consent

排除标准

  • •Under 18 years of age
  • •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

Allergy Skin Patch Testing

Experimental

On day 1, subjects will have a allergy skin patch test applied and a routine skin examination. On day 3, the patch test will be removed and documentation of the test sites using iPhone app. On day 5, the final assessment for allergic contact dermatitis will be conducted by a medical professional.

干预措施: AI-based smartphone application (Device)

Allergy Skin Patch Testing

Experimental

On day 1, subjects will have a allergy skin patch test applied and a routine skin examination. On day 3, the patch test will be removed and documentation of the test sites using iPhone app. On day 5, the final assessment for allergic contact dermatitis will be conducted by a medical professional.

干预措施: Allergen patch (Diagnostic Test)

结局指标

主要结局

AI algorithms predictions of reactions

时间窗: 6 months

Number of times the AI algorithms matches the human review of photographs of skin patch tests classification of reaction. The accuracy for the classification of regions within the test panel that either were a reaction (reaction grade 1+) or not (grade 0).

次要结局

  • Fitzpatrick skin type assessment(10 months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Hall

Principal Investigator

Mayo Clinic

研究点 (1)

Loading locations...

相似试验