Allergy Skin Patch Artificial Intelligence (AI)

  • STATUS
    Recruiting
  • days left to enroll
    86
  • participants needed
    225
  • sponsor
    Mayo Clinic
Updated on 5 May 2022
allergen
patch test
Accepts healthy volunteers

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.

Details
Condition Allergic Contact Dermatitis
Treatment AI-based smartphone application, Allergen patch
Clinical Study IdentifierNCT05339750
SponsorMayo Clinic
Last Modified on5 May 2022

Eligibility

Yes No Not Sure

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)
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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