Allergy Skin Patch Artificial Intelligence (AI)

Mayo Clinic

Status: Completed

Conditions: Allergic Contact Dermatitis

Treatments: Diagnostic Test: Allergen patch; Device: AI-based smartphone application

Study type: Interventional

Funder types: Other

Identifiers

NCT05339750

21-011596

Details and patient eligibility

About

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

Full 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.

Enrollment: 233 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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

Exclusion Criteria

• 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)

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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233 participants in 1 patient group

Allergy Skin Patch Testing

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Allergen patch

Device: AI-based smartphone application