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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06387472
Other study ID # 23-007636
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 8, 2024
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
AI algorithm to evaluate photographs of skin test patch regions
Interpretation of skin test patch regions via artificial intelligence (AI)
Allergen Patch
Contains dime-sized disks which have different substance to which a person may be allergic.

Locations

Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 not (grade 0). 1 week
Secondary Classification of test site region using a 5-point scale 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
Secondary False Positive Rate Number of false positive AI interpretation compared with human review interpretation 1 week
Secondary False Negative Rate Number of false negative AI interpretation compared with human review interpretation 1 week
Secondary Early termination of testing Number of early termination of testing 1 week
Secondary Participants that removed patches early Number of participants that removed patches early 1 week
Secondary Adverse events related to allergen exposure Number of adverse events related to allergen exposure 1 week
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