- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06387472
DermAI to Evaluate Human Factor of Testing
April 23, 2024 updated by: Matthew Hall, Mayo Clinic
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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Recruiting
- Mayo Clinic in Florida
-
Principal Investigator:
- Matthew Hall, MD
-
Contact:
- Laura Pacheco-Spann
- Phone Number: 904-953-0408
- Email: FLAQHSCS@mayo.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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 and a photograph image of where the patches were placed afterwards for human review and AI predictions of reactions.
|
Interpretation of skin test patch regions via artificial intelligence (AI)
Other Names:
Contains dime-sized disks which have different substance to which a person may be allergic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Classification of test site region reaction
Time Frame: 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).
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Classification of test site region using a 5-point scale
Time Frame: 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.
|
1 week
|
False Positive Rate
Time Frame: 1 week
|
Number of false positive AI interpretation compared with human review interpretation
|
1 week
|
False Negative Rate
Time Frame: 1 week
|
Number of false negative AI interpretation compared with human review interpretation
|
1 week
|
Early termination of testing
Time Frame: 1 week
|
Number of early termination of testing
|
1 week
|
Participants that removed patches early
Time Frame: 1 week
|
Number of participants that removed patches early
|
1 week
|
Adverse events related to allergen exposure
Time Frame: 1 week
|
Number of adverse events related to allergen exposure
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Matthew Hall, MD, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 29, 2024
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
December 31, 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 (Actual)
April 29, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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