Allergic Contact Dermatitis
Conditions
Brief summary
The purpose of this research is to assess human and artificial intelligence performance in grading contact dermatitis reactions in healthy volunteers.
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.
Interventions
DEVICEAI-based smartphone application
AI-based smartphone application to record and interpret the patch test results
DIAGNOSTIC_TESTAllergen 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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AI algorithms predictions of reactions | 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
| Measure | Time frame | Description |
|---|---|---|
| Fitzpatrick skin type assessment | 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. |
Countries
United States
Outcome results
None listed