NCT06387472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

May 8, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2024

Completed
9 months until next milestone

Results Posted

Study results publicly available

September 10, 2025

Completed
Last Updated

September 10, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

April 23, 2024

Results QC Date

July 21, 2025

Last Update Submit

August 20, 2025

Conditions

Contact Dermatitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

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

    1 week

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

    1 week

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

    1 week

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

    1 week

  • Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 4

    1 week

  • +5 more secondary outcomes

Study Arms (1)

DermAI and Patch Allergen Testing

EXPERIMENTAL

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 regionsDevice: Allergen Patch

Interventions

AI algorithm to evaluate photographs of skin test patch regionsDEVICE

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

Also known as: DermAI
DermAI and Patch Allergen Testing
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.

DermAI and Patch Allergen Testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Willing and able to provide informed consent.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Conditions

Dermatitis, Contact

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Results Point of Contact

Title
Matthew Hall, M.D.
Organization
Mayo Clinic
Hall.Matthew@mayo.edu
904-953-6412

Study Officials

  • Matthew Hall, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2024

First Posted

April 29, 2024

Study Start

May 8, 2024

Primary Completion

August 23, 2024

Study Completion

December 13, 2024

Last Updated

September 10, 2025

Results First Posted

September 10, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)