N/A
N=151
DermAI to Evaluate Human Factor of Testing
Contact Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT06387472 ↗Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Classification of Test Site Region Reaction — 1247; 163; 1126; 284 Skin Patch Interpretations
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AI algorithm to evaluate photographs of skin test patch regions (Device); Allergen Patch (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Classification of Test Site Region Reaction |
1247; 163; 1126; 284 | — |
| SECONDARY Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 0 |
100; 88.3 | — |
| SECONDARY Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 1 |
100; 70 | — |
| SECONDARY Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 2 |
100; 85.6 | — |
| SECONDARY Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 3 |
100; 100 | — |
| SECONDARY Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 4 |
100; 100 | — |
| SECONDARY False Positive Rate |
146 | — |
| SECONDARY False Negative Rate |
25 | — |
| SECONDARY Early Termination of Testing |
1 | — |
| SECONDARY Participants That Removed Patches Early |
1 | — |
| SECONDARY Adverse Events Related to Allergen Exposure |
— | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT06387472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.