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OpenTrials
Completed

NCT Number: NCT06387472

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.

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Key information

Conditions

Contact Dermatitis Dermatitis Dermatitis, Contact Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

AI algorithm to evaluate photographs of skin test patch regions

Device

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

Other names: DermAI

Allergen Patch

Device

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.

Primary outcomes

  1. 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 no reaction (grade 0).

Secondary outcomes

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

    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 the test site region using a 5-point scale: Grades 0 - 4 with higher scores indicating worse outcome.

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

    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 the test site region using a 5-point scale: Grades 0 - 4 with higher scores indicating worse outcome.

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

    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 the test site region using a 5-point scale: Grades 0 - 4 with higher scores indicating worse outcome.

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

    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 the test site region using a 5-point scale: Grades 0 - 4 with higher scores indicating worse outcome.

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

    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 the test site region using a 5-point scale: Grades 0 - 4 with higher scores indicating worse outcome.

  6. False Positive Rate

    Time frame: 1 week

    Number of false positive AI interpretations

  7. False Negative Rate

    Time frame: 1 week

    Number of false negative AI interpretations

  8. Early Termination of Testing

    Time frame: 1 week

    Number of early termination of testing

  9. Participants That Removed Patches Early

    Time frame: 1 week

    Number of participants that removed patches early

  10. Adverse Events Related to Allergen Exposure

    Time frame: 1 week

    Number of adverse events related to allergen exposure

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Adaptive Deployment of DermAI to Evaluate Human Factor of Testing

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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