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

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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Key information

Conditions

Leukoderma Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases Vitiligo

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Linkou Chang Gung Memorial Hospital

Taoyuan City, 33305, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ApolloVue® S100 Image System (Apollo Medical Optics)

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.

Other names: 510(K) Number: K201552 (class II)

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

Apollo Medical Optics, Ltd

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 23, 2021
Registry last updated: Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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