NCT04935424

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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..

Conditions

• Leukoderma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-03
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-06-23
• Last updated: 2023-04-11

Locations

1 site across 1 country: Taiwan