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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DermAI and Patch Allergen Testing | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI algorithm to evaluate photographs of skin test patch regions | Device | Interpretation of skin test patch regions via artificial intelligence (AI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
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Inclusion Criteria:
- Willing and able to provide informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Hall, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Six participants were not included in the analysis due to being a part of the pilot phase of the study. | Posted | Count of Units | Skin Patch Interpretations | 1 week | Skin Patch Interpretations | Skin Patch Interpretations |
|
Adverse events were collected from the time of informed consent through study completion, approximately 1 week.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Hall, M.D. | Mayo Clinic | 904-953-6412 | Hall.Matthew@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2024 | Jul 11, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| 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. |
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| 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. | 1 week |
| 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. | 1 week |
| 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. | 1 week |
| 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. | 1 week |
| False Positive Rate | Number of false positive AI interpretations | 1 week |
| False Negative Rate | Number of false negative AI interpretations | 1 week |
| Early Termination of Testing | Number of early termination of testing | 1 week |
| Participants That Removed Patches Early | Number of participants that removed patches early | 1 week |
| Adverse Events Related to Allergen Exposure | Number of adverse events related to allergen exposure | 1 week |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Six participants were not included in the analysis due to being a part of the pilot phase of the study. | Posted | Number | percentage of grade 0 interpretations | 1 week | Skin Patch Interpretations | Skin Patch Interpretations |
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| 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. | Six participants were not included in the analysis due to being a part of the pilot phase of the study. | Posted | Number | percentage of grade 1 interpretations | 1 week | Skin Patch Interpretations | Skin Patch Interpretations |
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| 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. | Six participants were not included in the analysis due to being a part of the pilot phase of the study. | Posted | Number | percentage of grade 2 interpretations | 1 week | Skin Patch Interpretations | Skin Patch Interpretations |
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| 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. | Six participants were not included in the analysis due to being a part of the pilot phase of the study. | Posted | Number | percentage of grade 3 interpretations | 1 week | Skin Patch Interpretations | Skin Patch Interpretations |
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| 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. | Six participants were not included in the analysis due to being a part of the pilot phase of the study. | Posted | Number | percentage of grade 4 interpretations | 1 week | Skin Patch Interpretations | Skin Patch Interpretations |
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| Secondary | False Positive Rate | Number of false positive AI interpretations | Six participants were not included in the analysis due to being a part of the pilot phase of the study. | Posted | Count of Units | Skin Patch Interpretations | 1 week | Skin Patch Interpretations | Skin Patch Interpretations |
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| Secondary | False Negative Rate | Number of false negative AI interpretations | Six participants were not included in the analysis due to being a part of the pilot phase of the study. | Posted | Count of Units | Skin Patch Interpretations | 1 week | Skin Patch Interpretations | Skin Patch Interpretations |
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| Secondary | Early Termination of Testing | Number of early termination of testing | Posted | Count of Participants | Participants | 1 week |
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| Secondary | Participants That Removed Patches Early | Number of participants that removed patches early | Posted | Count of Participants | Participants | 1 week |
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| Secondary | Adverse Events Related to Allergen Exposure | Number of adverse events related to allergen exposure | Posted | Count of Participants | Participants | 1 week |
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| 0 |
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| 151 |
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