Allergy Skin Patch Artificial Intelligence (AI)

NCT05339750 | Completed

• 1 other identifier: 21-011596
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to assess human and artificial intelligence performance in grading contact dermatitis reactions in healthy volunteers.

Conditions

Allergic Contact Dermatitis

Outcome Measures

Primary Outcomes (1)

• AI algorithms predictions of reactions

  Number of times the AI algorithms matches the human review of photographs of skin patch tests classification of reaction. The accuracy for the classification of regions within the test panel that either were a reaction (reaction grade 1+) or not (grade 0).

  6 months

Secondary Outcomes (1)

• Fitzpatrick skin type assessment

  10 months

Study Arms (1)

Allergy Skin Patch Testing

EXPERIMENTAL

On day 1, subjects will have a allergy skin patch test applied and a routine skin examination. On day 3, the patch test will be removed and documentation of the test sites using iPhone app. On day 5, the final assessment for allergic contact dermatitis will be conducted by a medical professional.

Device: AI-based smartphone application; Diagnostic Test: Allergen patch

Interventions

AI-based smartphone application DEVICE

AI-based smartphone application to record and interpret the patch test results

Allergy Skin Patch Testing

Allergen patch DIAGNOSTIC_TEST

Allergens applied to a patch which is placed on the skin on the forearm region. The patch contains 10 dime-sized disks which contain a different allergen.

Allergy Skin Patch Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over the age of 18
• Willing and able to provide informed consent

You may not qualify if:

• Under 18 years of age
• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Matthew Hall, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 21, 2022
• Study Start: February 15, 2022
• Primary Completion: September 23, 2022
• Study Completion: September 23, 2022
• Last Updated: January 6, 2023

Record last verified: 2023-01

Locations

US (1)