Contact Dermatitis
Conditions
Brief 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.
Interventions
DEVICEAI algorithm to evaluate photographs of skin test patch regions
Interpretation of skin test patch regions via artificial intelligence (AI)
DEVICEAllergen Patch
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Classification of Test Site Region Reaction | 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
| Measure | Time frame | Description |
|---|---|---|
| Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 1 | 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. |
| Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 2 | 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. |
| Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 3 | 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. |
| Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 4 | 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. |
| Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 0 | 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. |
| False Negative Rate | 1 week | Number of false negative AI interpretations |
| Early Termination of Testing | 1 week | Number of early termination of testing |
| Participants That Removed Patches Early | 1 week | Number of participants that removed patches early |
| Adverse Events Related to Allergen Exposure | 1 week | Number of adverse events related to allergen exposure |
| False Positive Rate | 1 week | Number of false positive AI interpretations |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DermAI and Patch Allergen Testing Subjects will have two allergen patches on their forearms for 48 hours. After 48 hours, the patches will be removed and a photograph will be taken where the patches were placed. This photograph will undergo interpretation by a medical professional and by the AI algorithm (DermAI) to evaluate for positive allergic reactions.
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. 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. | 151 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | DermAI and Patch Allergen Testing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 138 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 15 Participants |
| Race (NIH/OMB) Black or African American | 45 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 83 Participants |
| Region of Enrollment United States | 151 participants |
| Sex: Female, Male Female | 111 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 151 |
| other Total, other adverse events | 0 / 151 |
| serious Total, serious adverse events | 0 / 151 |
Outcome results
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 no reaction (grade 0).
Time frame: 1 week
Population: Six participants were not included in the analysis due to being a part of the pilot phase of the study.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| DermAI and Patch Allergen Testing | Classification of Test Site Region Reaction | Human Review Interpretation-Grade 0 | 1247 Skin Patch Interpretations |
| DermAI and Patch Allergen Testing | Classification of Test Site Region Reaction | Human Review Interpretation-Grade 1+ | 163 Skin Patch Interpretations |
| DermAI and Patch Allergen Testing | Classification of Test Site Region Reaction | AI Model Predication-Grade 0 | 1126 Skin Patch Interpretations |
| DermAI and Patch Allergen Testing | Classification of Test Site Region Reaction | AI Model Predication-Grade 1+ | 284 Skin Patch Interpretations |
Secondary
Adverse Events Related to Allergen Exposure
Number of adverse events related to allergen exposure
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DermAI and Patch Allergen Testing | Adverse Events Related to Allergen Exposure | 0 Participants |
Secondary
Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 0
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.
Time frame: 1 week
Population: Six participants were not included in the analysis due to being a part of the pilot phase of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DermAI and Patch Allergen Testing | Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 0 | Human Review Interpretation-Grade 0 | 100 percentage of grade 0 interpretations |
| DermAI and Patch Allergen Testing | Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 0 | AI Model Predication-Grade 0 | 88.3 percentage of grade 0 interpretations |
Secondary
Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 1
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.
Time frame: 1 week
Population: Six participants were not included in the analysis due to being a part of the pilot phase of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DermAI and Patch Allergen Testing | Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 1 | Human Review Interpretation-Grade 1 | 100 percentage of grade 1 interpretations |
| DermAI and Patch Allergen Testing | Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 1 | AI Model Predication-Grade 1 | 70 percentage of grade 1 interpretations |
Secondary
Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 2
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.
Time frame: 1 week
Population: Six participants were not included in the analysis due to being a part of the pilot phase of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DermAI and Patch Allergen Testing | Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 2 | Human Review Interpretation-Grade 2 | 100 percentage of grade 2 interpretations |
| DermAI and Patch Allergen Testing | Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 2 | AI Model Predication-Grade 2 | 85.6 percentage of grade 2 interpretations |
Secondary
Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 3
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.
Time frame: 1 week
Population: Six participants were not included in the analysis due to being a part of the pilot phase of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DermAI and Patch Allergen Testing | Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 3 | Human Review Interpretations-Grade 3 | 100 percentage of grade 3 interpretations |
| DermAI and Patch Allergen Testing | Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 3 | AI Model Predications-Grade 3 | 100 percentage of grade 3 interpretations |
Secondary
Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 4
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.
Time frame: 1 week
Population: Six participants were not included in the analysis due to being a part of the pilot phase of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DermAI and Patch Allergen Testing | Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 4 | Human Review Interpretations-Grade 4 | 100 percentage of grade 4 interpretations |
| DermAI and Patch Allergen Testing | Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 4 | AI Model Predications-Grade 4 | 100 percentage of grade 4 interpretations |
Secondary
Early Termination of Testing
Number of early termination of testing
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DermAI and Patch Allergen Testing | Early Termination of Testing | 1 Participants |
Secondary
False Negative Rate
Number of false negative AI interpretations
Time frame: 1 week
Population: Six participants were not included in the analysis due to being a part of the pilot phase of the study.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| DermAI and Patch Allergen Testing | False Negative Rate | 25 Skin Patch Interpretations |
Secondary
False Positive Rate
Number of false positive AI interpretations
Time frame: 1 week
Population: Six participants were not included in the analysis due to being a part of the pilot phase of the study.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| DermAI and Patch Allergen Testing | False Positive Rate | 146 Skin Patch Interpretations |
Secondary
Participants That Removed Patches Early
Number of participants that removed patches early
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DermAI and Patch Allergen Testing | Participants That Removed Patches Early | 1 Participants |