TeledermatologyTele patchNCT06213545
Diagnostic Accuracy of Teledermatology in Patch Test Interpretation
A study testing In-clinic interpretation and Photo interpretation in people with Teledermatology, run by Mahidol University at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to learn about accuracy of teledermatology in patch test interpretation in patch test\'s patients population. The main question[s] it aims to answer are: Accuracy of teledermatology in patch test interpretation by dermatologist Accuracy of teledermatology in patch test… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Teledermatology
- What is being tested?
- In-clinic interpretation and Photo interpretation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteThailand
- Study dates
- 3 Apr 2024to 24 Nov 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants in the study must be 18 years of age or older.
- Participants in the study must have undergone patch testing for contact allergies.
- Participants in the study should be able to take photos of test results on their back and/or arms using a mobile phone or personal camera, and send them to the researcher through the Line application and/or email within 48 hours, 96 hours, and on the 7th day.
- Participants in the study should be able to read and comprehend the questionnaire in Thai and respond to the questionnaire independently.
- Participants in the study must have at least one positive result in the patch testing.
- Participants in the study must provide consent to participate in the study by signing the informed consent document.
Who cannot join
- Participants in the study who are unable to attend follow-up appointments for result assessments.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of medicine, Siriraj hospital, Mahidol university
Bangkoknoi, Bangkok, 10700
About this study
The goal of this clinical trial is to learn about accuracy of teledermatology in patch test interpretation in patch test\'s patients population. The main question[s] it aims to answer are:
- Accuracy of teledermatology in patch test interpretation by dermatologist
- Accuracy of teledermatology in patch test interpretation by Residency
- Accuracy of teledermatology in patch test interpretation by Scitentist
- The factors influencing the interpretation of remote dermatologic patch test results from photographs of patients.
Read more
Participants will
- do patch test in Siriraj hospital and come to follow up at 48 hr and 72 hr for interpretation of patch test
- take a photo at home and sent the photo to contact clinic via online application or email on the day of 48 hr, 72 hr and 7 days following the interpretation of patch test
Researchers will compare in-clinic group and telephoto group to see if the accuracy of patch test interpretation is more or less.
- Conditions
- Teledermatology
- Being tested
- In-clinic interpretation, Photo interpretation
- Keywords
- teledermatology, patch test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-clinic interpretationDiagnostic test
Reading patch test result at clinic
Photo interpretationDiagnostic test
Reading patch test result by sending photo to clinic
| Study group | Role | What they receive |
|---|---|---|
| In-Clinic interpretation | Experimental | After doing patch test, patient come to Siriraj hospital to interpret the results at 48 hr and 72 hr. Receives: Diagnostic Test: In-clinic interpretation; Diagnostic Test: Photo interpretation |
| Photo interpretation | Experimental | After doing patch test, patient take a photo to Siriraj hospital by LINE application to interpret the results at 48 hr, 72 hr and 7 days Receives: Diagnostic Test: In-clinic interpretation; Diagnostic Test: Photo interpretation |
What is being measured
The primary outcome is the main question the study is designed to answer.
grading of patch test
sucess, intermediate and failure
Measured: 48 hours, 72 hours and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start3 Apr 2024
- Primary completion2 Sep 2024
- Study completion24 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TeledermatologyStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silada Kanokrungsee, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213545
- Sponsor's protocol ID
- COA 694/2023
- Acronym
- Tele patch
- Status last verified
- Nov 2024
- First submitted
- 10 Jan 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Prohibited from laws (and/or rules,regulations,contracts), Fear of inappropriate use of data
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Teledermatology in Patch Test Interpretation
- ClinicalTrials.gov ID
- NCT06213545
- Acronym / sponsor ID
- Tele patch / COA 694/2023
- Conditions
- Teledermatology
- Keywords
- teledermatology, patch test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 2 Sep 2024 (actual)
- Study completion
- 24 Nov 2024 (actual)
- First posted
- 19 Jan 2024 (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 goal of this clinical trial is to learn about accuracy of teledermatology in patch test interpretation in patch test\'s patients population. The main question[s] it aims to answer are:
- Accuracy of teledermatology in patch test interpretation by dermatologist
- Accuracy of teledermatology in patch test interpretation by Residency
- Accuracy of teledermatology in patch test interpretation by Scitentist
- The factors influencing the interpretation of remote dermatologic patch test results from photographs of patients.
Participants will
- do patch test in Siriraj hospital and come to follow up at 48 hr and 72 hr for interpretation of patch test
- take a photo at home and sent the photo to contact clinic via online application or email on the day of 48 hr, 72 hr and 7 days following the interpretation of patch test
Researchers will compare in-clinic group and telephoto group to see if the accuracy of patch test interpretation is more or less.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Clinic interpretation | Experimental | Diagnostic Test: In-clinic interpretation, Diagnostic Test: Photo interpretationAfter doing patch test, patient come to Siriraj hospital to interpret the results at 48 hr and 72 hr. |
| Photo interpretation | Experimental | Diagnostic Test: In-clinic interpretation, Diagnostic Test: Photo interpretationAfter doing patch test, patient take a photo to Siriraj hospital by LINE application to interpret the results at 48 hr, 72 hr and 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants in the study must be 18 years of age or older.
- Participants in the study must have undergone patch testing for contact allergies.
- Participants in the study should be able to take photos of test results on their back and/or arms using a mobile phone or personal camera, and send them to the researcher through the Line application and/or email within 48 hours, 96 hours, and on the 7th day.
- Participants in the study should be able to read and comprehend the questionnaire in Thai and respond to the questionnaire independently.
- Participants in the study must have at least one positive result in the patch testing.
Key exclusion criteria (1 listed)
- Participants in the study who are unable to attend follow-up appointments for result assessments.
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 |
|---|---|---|
| In-clinic interpretationReading patch test result at clinic | Diagnostic test | In-Clinic interpretation, Photo interpretation |
| Photo interpretationReading patch test result by sending photo to clinic | Diagnostic test | In-Clinic interpretation, Photo interpretation |
Primary outcome
grading of patch test
Time frame: 48 hours, 72 hours and 7 days
sucess, intermediate and failure
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 27 Nov 2024.
- Individual participant dataSharing planned: No. Prohibited from laws (and/or rules,regulations,contracts), Fear of inappropriate use of data
Related trials for Teledermatology
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Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-clinic interpretation and Photo interpretation in people with Teledermatology, run by Mahidol University at 1 site in Thailand.
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 6 inclusion and 1 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 27 Nov 2024. 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 Thailand. 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?
grading of patch test (time frame: 48 hours, 72 hours and 7 days). 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 27 Nov 2024.