Evaluation of Treatment for Leukoderma by Cellular Level Resolution Full-field Optical Coherence Tomography

April 9, 2023 updated by: Chau Yee Ng, Chang Gung Memorial Hospital

OCT is an optical technology that emerged as a non-invasive skin imaging for the skin. In this protocol, the investigators plan to study the optical imaging features of leukoderma. An estimated 65 subjects will be included in this trial.

This is an observational, non-randomised, non-controlled, prospective cohort study to observe the feasibility of in vivo OCT as a image tool in the diagnosis of leukoderma. Use of the device will not affect the clinical management of the subjects.

Scientific Aim:

To evaluate the feasibility ApolloVue S100 image system as a tool in the differential diagnosis of leukoderma..

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

65

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

  • Taiwan
      • Taoyuan City, Taiwan, 33305
        • Linkou Chang Gung Memorial Hospital

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subject with at least one leukoderma lesion

Description

Inclusion Criteria:

  1. Age ≧ 20
  2. Subject with at least one leukoderma lesion
  3. Willing to participate in the trial with informed consent

Exclusion Criteria:

  1. Age < 20
  2. Pregnant woman or woman wishing to be pregnant during the study, or during breastfeeding period
  3. The investigators consider inappropriate to participate in the trial.
  4. Open wound lesion.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental：Leukoderma
Device: ApolloVue® S100 image system
Device: ApolloVue® S100 Image System (Apollo Medical Optics)
The device is an in vivo non-invasive optical coherence tomography and will be used to obtain at least 6 medical images of normal and lesional skin, respectively, for both experimental group and control group. The ApolloVue S100 image system is a high resolution OCT imaging system that provide real-time visualization of human skin tissue microstructure. The system provides cellular level, two-dimensional, cross-sectional (B-scan) and en face (E-scan) that can assist clinical diagnosis.The system is also equipped with imaging guiding system that could assist in position scanning skin area.
Other Names:
  • 510(K) Number: K201552 (class II)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To describe characteristic features seen by Full-field Optical Coherence Tomography of leukoderma disorders.
Time Frame: 6 months
The study is a descriptive one. To researche the characteristic images of leukoderma. No formal statistical testing of correlations will be performed. All images will be evaluated as a group. First, the investigator will review the OCT images for each imaging site and will determine the presence/absence of leukoderma. Next, comparing with the leukoderma disorders images to highlight any features that may assist in the OCT evaluation.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

Apollo Medical Optics, Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 3, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 9, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20STW2-4-010-V1A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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