DermAI to Evaluate Human Factor of Testing

Not Applicable

Completed

• Conditions: Contact Dermatitis
• Interventions: Device: AI algorithm to evaluate photographs of skin test patch regions; Device: Allergen Patch

• Registration Number: NCT06387472
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-29
• Study Start: 2024-05-08
• Primary Completion: 2024-08-23
• Study Completion: 2024-12-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DermAI and Patch Allergen Testing	AI algorithm to evaluate photographs of skin test patch regions	Subjects will have two allergen patches on their forearms for 48 hours and a photograph image of where the patches were placed afterwards for human review and AI predictions of reactions.
DermAI and Patch Allergen Testing	Allergen Patch	Subjects will have two allergen patches on their forearms for 48 hours and a photograph image of where the patches were placed afterwards for human review and AI predictions of reactions.

Primary Outcome Measures

Name	Time	Method
Classification of test site region reaction	1 week	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 not (grade 0).

Secondary Outcome Measures

Name	Time	Method
Classification of test site region using a 5-point scale	1 week	Number of skin patch interpretation 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.
False Positive Rate	1 week	Number of false positive AI interpretation compared with human review interpretation
False Negative Rate	1 week	Number of false negative AI interpretation compared with human review interpretation
Participants that removed patches early	1 week	Number of participants that removed patches early
Early termination of testing	1 week	Number of early termination of testing
Adverse events related to allergen exposure	1 week	Number of adverse events related to allergen exposure

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States