DermAI to Evaluate Human Factor of Testing

Adaptive Deployment of DermAI to Evaluate Human Factor of Testing

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 Overview

• Status: Completed
• Conditions: Contact Dermatitis
• Intervention / Treatment: Device: AI algorithm to evaluate photographs of skin test patch regions; Device: Allergen Patch

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: DermAI and Patch Allergen Testing; Subjects will have two allergen patches on their forearms for 48 hours. After 48 hours, the patches will be removed and a photograph will be taken where the patches were placed. This photograph will undergo interpretation by a medical professional and by the AI algorithm (DermAI) to evaluate for positive allergic reactions.

Device: AI algorithm to evaluate photographs of skin test patch regions; Interpretation of skin test patch regions via artificial intelligence (AI); Other Names: DermAI; Device: Allergen Patch; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	1 week
Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 4	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.	1 week
False Positive Rate	Number of false positive AI interpretations	1 week
False Negative Rate	Number of false negative AI interpretations	1 week
Early Termination of Testing	Number of early termination of testing	1 week
Participants That Removed Patches Early	Number of participants that removed patches early	1 week
Adverse Events Related to Allergen Exposure	Number of adverse events related to allergen exposure	1 week

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Matthew Hall, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Actual): August 23, 2024
• Study Completion (Actual): December 13, 2024

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Skin and Connective Tissue Diseases; Dermatitis, Contact
• Other Study ID Numbers: 23-007636

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No