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

Study Overview
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Brief Summary
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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..

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

Conditions
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Leukoderma

Intervention / Treatment
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* Device: ApolloVue® S100 Image System (Apollo Medical Optics)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≧ 20 Subject with at least one leukoderma lesion Willing to participate in the trial with informed consent Exclusion Criteria: Age < 20 Pregnant woman or woman wishing to be pregnant during the study, or during breastfeeding period The investigators consider inappropriate to participate in the trial. Open wound lesion.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental：Leukoderma<br>Device: ApolloVue® S100 image system | Device: ApolloVue® S100 Image System (Apollo Medical Optics)<br>* 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.<br>* Other names: 510(K) Number: K201552 (class II);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe characteristic features seen by Full-field Optical Coherence Tomography of leukoderma disorders. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optical coherence tomography (OCT), dermatology, Full-Field OCT, Non-invasive image system, Leukoderma