Allergy Skin Patch Artificial Intelligence (AI)

Allergic Contact Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05339750
• Other study ID #: 21-011596
• Status: Completed
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: September 23, 2022

Study information

• Verified date: January 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: September 23, 2022
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Allergic Contact Dermatitis
• Dermatitis
• Dermatitis, Allergic Contact
• Dermatitis, Contact

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Mayo Clinic Clinical Trials