Skip to main content
OpenTrials
Completed

NCT Number: NCT05339750

Allergy Skin Patch Artificial Intelligence (AI)

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AI-based smartphone application

Device

AI-based smartphone application to record and interpret the patch test results

Allergen patch

Diagnostic Test

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.

Primary outcomes

  1. AI algorithms predictions of reactions

    Time frame: 6 months

    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).

Secondary outcomes

  1. Fitzpatrick skin type assessment

    Time frame: 10 months

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2022
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.