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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-03

Study Completion Date

2022-12-31

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..

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Detailed Description

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Conditions

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Leukoderma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental：Leukoderma

Device: ApolloVue® S100 image system

ApolloVue® S100 Image System (Apollo Medical Optics)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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510(K) Number: K201552 (class II)

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No