DermAI to Evaluate Human Factor of Testing

Contact Dermatitis Clinical Trial

Official title:

Adaptive Deployment of DermAI to Evaluate Human Factor of Testing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06387472
• Other study ID #: 23-007636
• Status: Recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Contact Dermatitis
• Dermatitis
• Dermatitis, Contact

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

External Links

•   Mayo Clinic Clinical Trials