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

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ClinicalTrials.gov Identifier: NCT04935424
Recruitment Status : Recruiting
First Posted : June 23, 2021
Last Update Posted : June 28, 2022
Sponsor:
Collaborator:
Apollo Medical Optics, Ltd
Information provided by (Responsible Party):
Chau Yee Ng, Chang Gung Memorial Hospital

Study Description
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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
Leukoderma Device: ApolloVue® S100 Image System (Apollo Medical Optics)

Study Design
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Study Type : Observational
Estimated 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 : August 3, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 Name: 510(K) Number: K201552 (class II)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subject with at least one leukoderma lesion
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04935424


Contacts
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Contact: Chau Yee Ng, MD +886-3-3281200 ext 3556 cyng87@cgmh.org.tw

Locations
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Taiwan
Linkou Chang Gung Memorial Hospital Recruiting
Taoyuan City, Taiwan, 33305
Contact: Chau Yee Ng, MD    +886-3-3281200 ext 3556    cyng87@cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Apollo Medical Optics, Ltd
More Information
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Publications:

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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: June 23, 2021    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chau Yee Ng, Chang Gung Memorial Hospital:
Optical coherence tomography (OCT)
dermatology
Full-Field OCT
Non-invasive image system
Leukoderma
Additional relevant MeSH terms:
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Hypopigmentation
Pigmentation Disorders
Skin Diseases