Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Apollo Medical Optics, Ltd | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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..
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental：Leukoderma | Device: ApolloVue® S100 image system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To describe characteristic features seen by Full-field Optical Coherence Tomography of leukoderma disorders. | 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. | 6 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subject with at least one leukoderma lesion
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linkou Chang Gung Memorial Hospital | Taoyuan City | 33305 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32107629 | Background | Liu Z, Jiang M, Zhao J, Wang Q, Zhang C, Gao M, Gu M, Xiang L. Efficacy of a wound-dressing biomaterial on prevention of postinflammatory hyperpigmentation after suction blister epidermal grafting in stable vitiligo patients: a controlled assessor-blinded clinical study with in vitro bioactivity investigation. Arch Dermatol Res. 2020 Nov;312(9):635-645. doi: 10.1007/s00403-020-02049-2. Epub 2020 Feb 27. | |
| 32198977 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Background |
| Abdel-Malek ZA, Jordan C, Ho T, Upadhyay PR, Fleischer A, Hamzavi I. The enigma and challenges of vitiligo pathophysiology and treatment. Pigment Cell Melanoma Res. 2020 Nov;33(6):778-787. doi: 10.1111/pcmr.12878. Epub 2020 Apr 12. |
| 24249892 | Background | Li W, Wang S, Xu AE. Role of in vivo reflectance confocal microscopy in determining stability in vitiligo: a preliminary study. Indian J Dermatol. 2013 Nov;58(6):429-32. doi: 10.4103/0019-5154.119948. |
| 22416879 | Background | Alghamdi KM, Kumar A, Taieb A, Ezzedine K. Assessment methods for the evaluation of vitiligo. J Eur Acad Dermatol Venereol. 2012 Dec;26(12):1463-71. doi: 10.1111/j.1468-3083.2012.04505.x. Epub 2012 Mar 15. |
| 19889023 | Background | Kang HY, Bahadoran P, Ortonne JP. Reflectance confocal microscopy for pigmentary disorders. Exp Dermatol. 2010 Mar;19(3):233-9. doi: 10.1111/j.1600-0625.2009.00983.x. Epub 2009 Nov 2. |
| 21429011 | Background | Lai LG, Xu AE. In vivo reflectance confocal microscopy imaging of vitiligo, nevus depigmentosus and nevus anemicus. Skin Res Technol. 2011 Nov;17(4):404-10. doi: 10.1111/j.1600-0846.2011.00521.x. Epub 2011 Mar 24. |