Allergy Skin Patch Artificial Intelligence (AI)

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

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

Study Overview

• Status: Completed
• Conditions: Allergic Contact Dermatitis
• Intervention / Treatment: Device: AI-based smartphone application; Diagnostic test: Allergen patch

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.

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Allergy Skin Patch Testing; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AI algorithms predictions of reactions	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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fitzpatrick skin type assessment	Number of times the AI algorithms matches the human review of photographs of skin patch tests over the entire range of Fitzpatrick skin types. The Fitzpatrick skin typing categorize skin type according to how much melanin is present.	10 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Matthew Hall, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): September 23, 2022
• Study Completion (Actual): September 23, 2022

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact
• Other Study ID Numbers: 21-011596

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No