- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06213545
Diagnostic Accuracy of Teledermatology in Patch Test Interpretation (Tele patch)
November 24, 2024 updated by: Silada Kanokrungsee, Mahidol University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bangkok
-
Bangkoknoi, Bangkok, Thailand, 10700
- Faculty of Medicine, Siriraj Hospital, Mahidol University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Participants in the study who are unable to attend follow-up appointments for result assessments.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: In-Clinic interpretation
After doing patch test, patient come to Siriraj hospital to interpret the results at 48 hr and 72 hr.
|
Reading patch test result at clinic
Reading patch test result by sending photo to clinic
|
|
Experimental: Photo interpretation
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
|
Reading patch test result at clinic
Reading patch test result by sending photo to clinic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
grading of patch test
Time Frame: 48 hours, 72 hours and 7 days
|
sucess, intermediate and failure
|
48 hours, 72 hours and 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2024
Primary Completion (Actual)
September 2, 2024
Study Completion (Actual)
November 24, 2024
Study Registration Dates
First Submitted
January 10, 2024
First Submitted That Met QC Criteria
January 18, 2024
First Posted (Actual)
January 19, 2024
Study Record Updates
Last Update Posted (Estimated)
November 27, 2024
Last Update Submitted That Met QC Criteria
November 24, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- COA 694/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Prohibited from laws (and/or rules,regulations,contracts), Fear of inappropriate use of data
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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