Contact DermatitisNCT06387472
DermAI to Evaluate Human Factor of Testing
A study testing AI algorithm to evaluate photographs of skin test patch regions and Allergen Patch in people with Contact Dermatitis, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contact Dermatitis
- What is being tested?
- AI algorithm to evaluate photographs of skin test patch regions and Allergen Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2024to 13 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptive Deployment of 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.
- Conditions
- Contact Dermatitis
- Being tested
- AI algorithm to evaluate photographs of skin test patch regions, Allergen Patch
- Medical subject headings
- Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI algorithm to evaluate photographs of skin test patch regionsDevice
Also called DermAI
Interpretation of skin test patch regions via artificial intelligence (AI)
Allergen PatchDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AI algorithm to evaluate photographs of skin test patch regions; Device: Allergen Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 week
Secondary outcomes (10)
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.
Measured: 1 week
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week
False Positive Rate
Number of false positive AI interpretations
Measured: 1 week
False Negative Rate
Number of false negative AI interpretations
Measured: 1 week
Early Termination of Testing
Number of early termination of testing
Measured: 1 week
Participants That Removed Patches Early
Number of participants that removed patches early
Measured: 1 week
Adverse Events Related to Allergen Exposure
Number of adverse events related to allergen exposure
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start8 May 2024
- Primary completion23 Aug 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Contact DermatitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Hall, Mayo Clinic
- Investigators
- Matthew Hall, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387472
- Sponsor's protocol ID
- 23-007636
- Status last verified
- Aug 2025
- First submitted
- 23 Apr 2024
- Last updated
- 10 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Deployment of DermAI to Evaluate Human Factor of Testing
- ClinicalTrials.gov ID
- NCT06387472
- Acronym / sponsor ID
- 23-007636
- Conditions
- Contact Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 23 Aug 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Posted 10 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DermAI and Patch Allergen Testing | Experimental | Device: AI algorithm to evaluate photographs of skin test patch regions, Device: Allergen PatchSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Willing and able to provide informed consent.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI algorithm to evaluate photographs of skin test patch regionsAlso: DermAIInterpretation of skin test patch regions via artificial intelligence (AI) | Device | DermAI and Patch Allergen Testing |
| Allergen PatchContains 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. | Device | DermAI and Patch Allergen Testing |
Primary outcome
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).
10 secondary outcomes
Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 0
Time frame: 1 week
Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 1
Time frame: 1 week
Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 2
Time frame: 1 week
Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 3
Time frame: 1 week
Classification of Test Site Region Using a 5-point Scale Where Skin Patch Interpretations Were a Grade 4
Time frame: 1 week
False Positive Rate
Time frame: 1 week
False Negative Rate
Time frame: 1 week
Early Termination of Testing
Time frame: 1 week
Participants That Removed Patches Early
Time frame: 1 week
Adverse Events Related to Allergen Exposure
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Exploring Skin Barrier Function, Recurrence of Diabetes Device-Related Contact Dermatitis, and Evaluation of Hydrocolloid and Silicone-Based Patches for Its Prevention in Children and Adolescents With Type 1 Diabetes
Contact Dermatitis, Type 1 Diabetes Mellitus
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Reliability of Expired Allergens in Patch Testing: A Comparative Study With Non-Expired Series
Allergic Contact Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Hall, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI algorithm to evaluate photographs of skin test patch regions and Allergen Patch in people with Contact Dermatitis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification of Test Site Region Reaction (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.