LeukodermaNCT04935424
Evaluation of Treatment for Leukoderma by Cellular Level Resolution Full-field Optical Coherence Tomography
An observational study of Leukoderma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Leukoderma
- What is being tested?
- ApolloVue® S100 Image System (Apollo Medical Optics)
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Aug 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject with at least one leukoderma lesion
Who may be able to join
- Age ≧ 20
- Subject with at least one leukoderma lesion
- Willing to participate in the trial with informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- ApolloVue® S100 Image System (Apollo Medical Optics)
- Keywords
- Optical coherence tomography (OCT), dermatology, Full-Field OCT, Non-invasive image system, Leukoderma
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApolloVue® S100 Image System (Apollo Medical Optics)Device
Also called 510(K) Number: K201552 (class II)
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental：Leukoderma | Device: ApolloVue® S100 image system Receives: Device: ApolloVue® S100 Image System (Apollo Medical Optics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start3 Aug 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for LeukodermaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Apollo Medical Optics, Ltd
- Responsible party
- Principal investigator, Chau Yee Ng, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935424
- Sponsor's protocol ID
- 20STW2-4-010-V1A3
- Status last verified
- Apr 2023
- First submitted
- 4 May 2021
- Last updated
- 11 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32107629Abdel-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.
PubMed 32198977Li 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.
PubMed 24249892Alghamdi 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.
PubMed 22416879Kang 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.
PubMed 19889023Lai 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.
PubMed 21429011
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatment for Leukoderma by Cellular Level Resolution Full-field Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT04935424
- Acronym / sponsor ID
- 20STW2-4-010-V1A3
- Conditions
- Leukoderma
- Keywords
- Optical coherence tomography (OCT), dermatology, Full-Field OCT, Non-invasive image system, Leukoderma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Apollo Medical Optics, Ltd
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental：Leukoderma | – | Device: ApolloVue® S100 Image System (Apollo Medical Optics)Device: ApolloVue® S100 image system |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject with at least one leukoderma lesion
Key inclusion criteria (3 listed)
- Age ≧ 20
- Subject with at least one leukoderma lesion
- Willing to participate in the trial with informed consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApolloVue® S100 Image System (Apollo Medical Optics)Also: 510(K) Number: K201552 (class II)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. | Device | Experimental：Leukoderma |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Background: PubMed 32107629Liu 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.
- Background: PubMed 32198977Abdel-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.
- Background: PubMed 24249892Li 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.
- Background: PubMed 22416879Alghamdi 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.
- Background: PubMed 19889023Kang 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.
- Background: PubMed 21429011Lai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukoderma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe characteristic features seen by Full-field Optical Coherence Tomography of leukoderma disorders. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04935424, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.