NCT06213545

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 3, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

January 10, 2024

Last Update Submit

November 24, 2024

Conditions

Keywords

teledermatologypatch test

Outcome Measures

Primary Outcomes (1)

  • grading of patch test

    sucess, intermediate and failure

    48 hours, 72 hours and 7 days

Study Arms (2)

In-Clinic interpretation

EXPERIMENTAL

After doing patch test, patient come to Siriraj hospital to interpret the results at 48 hr and 72 hr.

Diagnostic Test: In-clinic interpretationDiagnostic 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

Diagnostic Test: In-clinic interpretationDiagnostic Test: Photo interpretation

Interventions

Reading patch test result at clinic

In-Clinic interpretationPhoto interpretation
Photo interpretationDIAGNOSTIC_TEST

Reading patch test result by sending photo to clinic

In-Clinic interpretationPhoto interpretation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants in the study who are unable to attend follow-up appointments for result assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Siriraj hospital, Mahidol university

Bangkoknoi, Bangkok, 10700, Thailand

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Dermatology, Siriraj hospital

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 19, 2024

Study Start

April 3, 2024

Primary Completion

September 2, 2024

Study Completion

November 24, 2024

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Prohibited from laws (and/or rules,regulations,contracts), Fear of inappropriate use of data

Locations