NCT05339750

Allergy Skin Patch Artificial Intelligence (AI)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Allergic Contact Dermatitis

Interventions

Type	Name	Description
DEVICE	AI-based smartphone application	AI-based smartphone application to record and interpret the patch test results
DIAGNOSTIC_TEST	Allergen patch	Allergens applied to a patch which is placed on the skin on the forearm region. The patch contains 10 dime-sized disks which contain a different allergen.

Timeline

• Start date: 2022-02-15
• Primary completion: 2022-09-23
• Completion: 2022-09-23
• First posted: 2022-04-21
• Last updated: 2023-01-06

Locations

1 site across 1 country: United States