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Allergy Skin Patch Artificial Intelligence (AI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05339750
Recruitment Status : Completed
First Posted : April 21, 2022
Last Update Posted : January 6, 2023
Sponsor:
Information provided by (Responsible Party):
Matthew Hall, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Allergic Contact Dermatitis Device: AI-based smartphone application Diagnostic Test: Allergen patch Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Democratization of Allergy Skin Patch Testing to Increase Efficiency and Scale of the Practice
Actual Study Start Date : February 15, 2022
Actual Primary Completion Date : September 23, 2022
Actual Study Completion Date : September 23, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05339750


Locations
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United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Matthew Hall, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Matthew Hall, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT05339750    
Other Study ID Numbers: 21-011596
First Posted: April 21, 2022    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Contact
Dermatitis, Allergic Contact
Skin Diseases
 Hypersensitivity
Immune System Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed