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

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04935424
Collaborator
Apollo Medical Optics, Ltd (Industry)
65
Enrollment
1
Location
12.9
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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..

Condition or Disease Intervention/Treatment Phase
  • Device: ApolloVue® S100 Image System (Apollo Medical Optics)

Study Design

Study Type:
Observational
Anticipated Enrollment :
65 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Evaluation of Treatment for Leukoderma by Cellular Level Resolution Full-field Optical Coherence Tomography
Actual Study Start Date :
Aug 3, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm 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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To describe characteristic features seen by Full-field Optical Coherence Tomography of leukoderma disorders. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Linkou Chang Gung Memorial Hospital Taoyuan City Taiwan 33305

    Sponsors and Collaborators

    • Chang Gung Memorial Hospital
    • Apollo Medical Optics, Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Chau Yee Ng, Principal Investigator, Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT04935424
    Other Study ID Numbers:
    • 20STW2-4-010-V1A3
    First Posted:
    Jun 23, 2021
    Last Update Posted:
    Jun 28, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chau Yee Ng, Principal Investigator, Chang Gung Memorial Hospital
    Optical coherence tomography (OCT)
    dermatology
    Full-Field OCT
    Non-invasive image system
    Leukoderma
    Additional relevant MeSH terms:
    Hypopigmentation

    Study Results

    No Results Posted as of Jun 28, 2022