Allergic Contact DermatitisNCT05339750
Allergy Skin Patch Artificial Intelligence (AI)
A study testing AI-based smartphone application and Allergen patch in people with Allergic Contact Dermatitis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to assess human and artificial intelligence performance in grading contact dermatitis reactions in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Contact Dermatitis
- What is being tested?
- AI-based smartphone application and Allergen patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 23 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults over the age of 18
- Willing and able to provide informed consent
Who cannot join
- Under 18 years of age
- 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: Democratization of Allergy Skin Patch Testing to Increase Efficiency and Scale of the Practice
The purpose of this research is to assess human and artificial intelligence performance in grading contact dermatitis reactions in healthy volunteers.
Read the detailed description
Study participation involves three visits to the study site on Days 1, 3, and 5, and completion of a demographics and allergy history questionnaire. Researchers will review medical history and current medications. On Day 1 a patch will be applied with 10 allergens and a routine skin examination will be conducted and a photograph will be taken of the forearm. On day 3, subjects will return to remove the patch test and have photographs of the area taken. On day 5, the final assessment for allergic contact dermatitis will be performed and photographs of the area taken.
Key Information: The most common side effect of skin testing is slightly swollen, red, itchy bumps (wheals). These wheals may be most noticeable during the test. In some, an area of swelling, redness and itching may develop a few hours after the test and remain for a couple of days. Rarely, allergy skin tests can produce a severe, immediate allergic reaction. The patches are worn on the forearm for 48 hours. During this time, bathing and activities that cause heavy sweating should be avoided. Irritated skin at the patch site may indicate an allergy. If a positive test result is documented, a medical professional will provide education and recommend follow up with primary care provider.
- Conditions
- Allergic Contact Dermatitis
- Being tested
- AI-based smartphone application, Allergen patch
- Medical subject headings
- Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based smartphone applicationDevice
AI-based smartphone application to record and interpret the patch test results
Allergen patchDiagnostic test
Allergens applied to a patch which is placed on the skin on the forearm region. The patch contains 10 dime-sized disks which contain a different allergen.
| Study group | Role | What they receive |
|---|---|---|
| Allergy Skin Patch Testing | Experimental | On day 1, subjects will have a allergy skin patch test applied and a routine skin examination. On day 3, the patch test will be removed and documentation of the test sites using iPhone app. On day 5, the final assessment for allergic contact dermatitis will be conducted by a medical professional. Receives: Device: AI-based smartphone application; Diagnostic Test: Allergen patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
AI algorithms predictions of reactions
Number of times the AI algorithms matches the human review of photographs of skin patch tests classification of reaction. The accuracy for the classification of regions within the test panel that either were a reaction (reaction grade 1+) or not (grade 0).
Measured: 6 months
Secondary outcomes (1)
Fitzpatrick skin type assessment
Number of times the AI algorithms matches the human review of photographs of skin patch tests over the entire range of Fitzpatrick skin types. The Fitzpatrick skin typing categorize skin type according to how much melanin is present.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start15 Feb 2022
- Primary completion23 Sep 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 233 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
- NCT05339750
- Sponsor's protocol ID
- 21-011596
- Status last verified
- Jan 2023
- First submitted
- 4 Apr 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Democratization of Allergy Skin Patch Testing to Increase Efficiency and Scale of the Practice
- ClinicalTrials.gov ID
- NCT05339750
- Acronym / sponsor ID
- 21-011596
- Conditions
- Allergic Contact Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
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 assess human and artificial intelligence performance in grading contact dermatitis reactions in healthy volunteers.
Detailed description
Study participation involves three visits to the study site on Days 1, 3, and 5, and completion of a demographics and allergy history questionnaire. Researchers will review medical history and current medications. On Day 1 a patch will be applied with 10 allergens and a routine skin examination will be conducted and a photograph will be taken of the forearm. On day 3, subjects will return to remove the patch test and have photographs of the area taken. On day 5, the final assessment for allergic contact dermatitis will be performed and photographs of the area taken.
Key Information: The most common side effect of skin testing is slightly swollen, red, itchy bumps (wheals). These wheals may be most noticeable during the test. In some, an area of swelling, redness and itching may develop a few hours after the test and remain for a couple of days. Rarely, allergy skin tests can produce a severe, immediate allergic reaction. The patches are worn on the forearm for 48 hours. During this time, bathing and activities that cause heavy sweating should be avoided. Irritated skin at the patch site may indicate an allergy. If a positive test result is documented, a medical professional will provide education and recommend follow up with primary care provider.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allergy Skin Patch Testing | Experimental | Device: AI-based smartphone application, Diagnostic Test: Allergen patchOn day 1, subjects will have a allergy skin patch test applied and a routine skin examination. On day 3, the patch test will be removed and documentation of the test sites using iPhone app. On day 5, the final assessment for allergic contact dermatitis will be conducted by a medical professional. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults over the age of 18
- Willing and able to provide informed consent
Key exclusion criteria (7 listed)
- Under 18 years of age
- 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.
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-based smartphone applicationAI-based smartphone application to record and interpret the patch test results | Device | Allergy Skin Patch Testing |
| Allergen patchAllergens applied to a patch which is placed on the skin on the forearm region. The patch contains 10 dime-sized disks which contain a different allergen. | Diagnostic test | Allergy Skin Patch Testing |
Primary outcome
AI algorithms predictions of reactions
Time frame: 6 months
Number of times the AI algorithms matches the human review of photographs of skin patch tests classification of reaction. The accuracy for the classification of regions within the test panel that either were a reaction (reaction grade 1+) or not (grade 0).
1 secondary outcome
Fitzpatrick skin type assessment
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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-based smartphone application and Allergen patch in people with Allergic 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 2 inclusion and 7 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 6 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AI algorithms predictions of reactions (time frame: 6 months). 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 6 Jan 2023.