Trial Outcomes & Findings for DermAI to Evaluate Human Factor of Testing (NCT NCT06387472)

NCT ID: NCT06387472

Last Updated: 2025-09-10

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 151 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2025-09-10

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	151
Overall Study COMPLETED	147
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	2
Overall Study Physician Decision	1

Baseline Characteristics

DermAI to Evaluate Human Factor of Testing

Baseline characteristics by cohort

Measure	DermAI and Patch Allergen Testing n=151 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	138 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Sex: Female, Male Female	111 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	45 Participants n=5 Participants
Race (NIH/OMB) White	83 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	151 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: Six participants were not included in the analysis due to being a part of the pilot phase of the study.

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).

Outcome measures

Measure	DermAI and Patch Allergen Testing n=1410 Skin Patch Interpretations 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.
Classification of Test Site Region Reaction Human Review Interpretation-Grade 0	1247 Skin Patch Interpretations
Classification of Test Site Region Reaction Human Review Interpretation-Grade 1+	163 Skin Patch Interpretations
Classification of Test Site Region Reaction AI Model Predication-Grade 0	1126 Skin Patch Interpretations
Classification of Test Site Region Reaction AI Model Predication-Grade 1+	284 Skin Patch Interpretations

SECONDARY outcome

Timeframe: 1 week

Population: Six participants were not included in the analysis due to being a part of the pilot phase of the study.

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.

Outcome measures

Measure	DermAI and Patch Allergen Testing n=1247 Skin Patch Interpretations 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.
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
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 outcome

Timeframe: 1 week

Population: Six participants were not included in the analysis due to being a part of the pilot phase of the study.

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.

Outcome measures

Measure	DermAI and Patch Allergen Testing n=20 Skin Patch Interpretations 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.
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
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 outcome

Timeframe: 1 week

Population: Six participants were not included in the analysis due to being a part of the pilot phase of the study.

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.

Outcome measures

Measure	DermAI and Patch Allergen Testing n=132 Skin Patch Interpretations 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.
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
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 outcome

Timeframe: 1 week

Population: Six participants were not included in the analysis due to being a part of the pilot phase of the study.

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.

Outcome measures

Measure	DermAI and Patch Allergen Testing n=8 Skin Patch Interpretations 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.
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
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 outcome

Timeframe: 1 week

Population: Six participants were not included in the analysis due to being a part of the pilot phase of the study.

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.

Outcome measures

Measure	DermAI and Patch Allergen Testing n=3 Skin Patch Interpretations 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.
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
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 outcome

Timeframe: 1 week

Population: Six participants were not included in the analysis due to being a part of the pilot phase of the study.

Number of false positive AI interpretations

Outcome measures

Measure

DermAI and Patch Allergen Testing n=1410 Skin Patch Interpretations 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.

False Positive Rate

146 Skin Patch Interpretations

SECONDARY outcome

Timeframe: 1 week

Population: Six participants were not included in the analysis due to being a part of the pilot phase of the study.

Number of false negative AI interpretations

Outcome measures

Measure

DermAI and Patch Allergen Testing n=1410 Skin Patch Interpretations 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.

False Negative Rate

25 Skin Patch Interpretations

SECONDARY outcome

Timeframe: 1 week

Number of early termination of testing

Outcome measures

Measure

DermAI and Patch Allergen Testing n=151 Participants 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.

Early Termination of Testing

1 Participants

SECONDARY outcome

Timeframe: 1 week

Number of participants that removed patches early

Outcome measures

Measure

DermAI and Patch Allergen Testing n=151 Participants 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.

Participants That Removed Patches Early

1 Participants

SECONDARY outcome

Timeframe: 1 week

Number of adverse events related to allergen exposure

Outcome measures

Measure

DermAI and Patch Allergen Testing n=151 Participants 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.

Adverse Events Related to Allergen Exposure

0 Participants

Adverse Events

DermAI and Patch Allergen Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthew Hall, M.D.

Mayo Clinic

Phone: 904-953-6412

Email: Hall.Matthew@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place