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

Completed

• Conditions: Leukoderma
• Interventions: Device: ApolloVue® S100 Image System (Apollo Medical Optics)

• Registration Number: NCT04935424
• Lead Sponsor: Chang Gung Memorial Hospital

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..

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-23
• Study Start: 2021-08-03
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-09
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental：Leukoderma	ApolloVue® S100 Image System (Apollo Medical Optics)	Device: ApolloVue® S100 image system

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan City, Taiwan