DermAI to Evaluate Human Factor of Testing

Mayo Clinic

Status: Completed

Conditions: Contact Dermatitis

Treatments: Device: AI algorithm to evaluate photographs of skin test patch regions; Device: Allergen Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT06387472

23-007636

Details and patient eligibility

About

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.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

- Willing and able to provide informed consent.

Exclusion criteria

• 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: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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151 participants in 1 patient group

DermAI and Patch Allergen Testing

Experimental group

Description:

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.

Treatment:

Device: Allergen Patch

Device: AI algorithm to evaluate photographs of skin test patch regions