Clinical trial NCT04935424: Evaluation of Treatment for Leukoderma by Cellular Level Resolution Full-field Optical Coherence Tomography
Official title: Evaluation of Treatment for Leukoderma by Cellular Level Resolution Full-field Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukoderma
Keywords: Optical coherence tomography (OCT)
dermatology
Full-Field OCT
Non-invasive image system
Leukoderma
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Apollo Medical Optics, Ltd
First posted: 2021-06-23
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject with at least one leukoderma lesion

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..


Eligibility criteria: 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.

Primary outcomes:
measure: To describe characteristic features seen by Full-field Optical Coherence Tomography of leukoderma disorders.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
References:
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