NCT06387472 - DermAI to Evaluate Human Factor of Testing | Crick

Overview

The purpose of this research is to improve how well remote patch allergy testing works and make sure they are easy and practical for people to use from home.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

SCREENING

Masking

NONE

Enrollment

151

Conditions

Contact Dermatitis

Interventions

AI algorithm to evaluate photographs of skin test patch regionsDEVICE

Interpretation of skin test patch regions via artificial intelligence (AI)

Allergen PatchDEVICE

Contains dime-sized disks which have different substance to which a person may be allergic. Two different patches were used due to the number of allergens being tested. Each patch can only hold 10 allergens and 14 allergens were tested in patients.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: \- Willing and able to provide informed consent. Exclusion Criteria: * 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).

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Classification of Test Site Region Reaction

Number of skin patch interpretations using novel AI algorithms analysis to be in concordant with human review interpretation for the classification of regions within the test panel that either were a reaction (reaction grade 1+) or no reaction (grade 0).

Time frame: 1 week

Secondary Outcomes

Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 0

Number of skin patch interpretations using novel AI algorithms analysis to be in concordant with human review interpretation for the classification of the test site region using a 5-point scale: Grades 0 - 4 with higher scores indicating worse outcome.

Time frame: 1 week

Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 1

Number of skin patch interpretations using novel AI algorithms analysis to be in concordant with human review interpretation for the classification of the test site region using a 5-point scale: Grades 0 - 4 with higher scores indicating worse outcome.

Time frame: 1 week

Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 2

Number of skin patch interpretations using novel AI algorithms analysis to be in concordant with human review interpretation for the classification of the test site region using a 5-point scale: Grades 0 - 4 with higher scores indicating worse outcome.

Time frame: 1 week

Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 3

Number of skin patch interpretations using novel AI algorithms analysis to be in concordant with human review interpretation for the classification of the test site region using a 5-point scale: Grades 0 - 4 with higher scores indicating worse outcome.