Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
NCT Number: NCT05339750
The purpose of this research is to assess human and artificial intelligence performance in grading contact dermatitis reactions in healthy volunteers.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Jacksonville, Florida, 32224, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AI-based smartphone application to record and interpret the patch test results
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.
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).
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.
Mayo Clinic
Other
Democratization of Allergy Skin Patch Testing to Increase Efficiency and Scale of the Practice
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.
NCT07673484
Allergic Contact Dermatitis, Cicatrix
Küçükçekmece, Istanbul, Turkey (Türkiye)
View Trial DetailsNCT05498467
Allergic Contact Dermatitis, Dermatitis
Hellerup, Denmark
View Trial DetailsNCT03680131
Allergic Contact Dermatitis, Dermatitis
Long Beach, California, United States
View Trial DetailsNCT03945760
Allergic Contact Dermatitis, Dermatitis
Fairborn, Ohio, United States
View Trial Details