Healthy SkinNCT04406454

The Application of Non-invasive and Cellular Level Resolution Fullfield Optical Coherence Tomography: Establishment and Analysis of Subcutaneous Cellular Level Image Database of Anatomical Locations in Healthy Volunteers and Evaluation of Usability

An observational study of Healthy Skin and Nevus, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

ApolloVue® S100 Image System is a medical device class II. The objective of this protocol is to image skin of healthy volunteers and to evaluate the performance of full-field optical coherence tomography (FF-OCT) device - the ApolloVue® S100 Image System in imaging skin microstructures of healthy skin at different… Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Healthy Skin, Nevus
What is being tested?: ApolloVue® S100 Image System
Type of treatment: Medical device
How many people: 60 participants
Where: 1 siteTaiwan
Study dates: 6 Jul 2020to 8 Feb 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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: The population from healthy volunteers will be selected.

Who may be able to join

All age will be recruited.
Both genders will be recruited.
All skin types will be recruited. Skin type I-VI (Fitzpatrick scale)
Type I always burns, never tans (unexposed skin color: white)
Type II usually burns, tans less than average (with difficulty) (unexposed skin color: white)
Type III sometimes mild burns, tans about average (unexposed skin color: white)

Show all 12Show fewer

Type IV rarely burns, tans more than average (with easy) (unexposed skin color: white)
Type V very rarely burns (unexposed skin color: brown)
Type VI never burns (unexposed skin color: black)
Has healthy skin at 5 anatomical locations including face, back, dorsal forearm, volar forearm, and calf.
Has at least a nevus without superficial scales and crusting
Willing to provide informed consent

Who cannot join

Individuals who have a systemic skin disorder.
Individuals who have a history of severe skin condition
Individuals with surgeries/cosmetic surgeries/micro cosmetic surgery (eg. cosmetic injections and/or laser etc.) on healthy skin at the 5 anatomical locations and nevi (see inclusion criteria 5) in last 12 months and a physician determine the surgery will affect outcome of the OCT images.
Not willing to cooperate with methods and related procedures of this trial/study

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Taipei Veterans General Hospital
Taipei, Beitou District, 11217

Other trials in Taiwan

About this study

Read the detailed description

The OCT can provide cellular resolution (~1μm in lateral and axial directions) images. A cellular resolution OCT has the characteristics of non-invasive, non-radioactive, labelfree, real-time and high tissue penetration depth that are highly valuable for clinical use. This technology allows visualization of important structural features such as the epidermis and dermis and the epidermal-dermal junction. OCT has the advantage of generating cross-sectional images, like the orientation of pathology slides.

The ApolloVue® S100 Image System is intended to be used as a non-invasive imaging tool in the evaluation of external human skin tissue microstructure by providing two-dimensional, crosssectional (B-scan) and en face (E-scan) real-time visualization for assessment by physicians to support in forming a clinical judgment. For the ApolloVue® S100 Image System image, both cross-sectional view and en face view can be obtained to assist physicians' diagnosis. With both views, physicians can obtain important spatial information in regards to the skin. Besides, the ApolloVue® S100 Image System is equipped with an image guiding system which provides a high-resolution dermatoscope like image, for the positioning of skin sites for optical biopsies.

In this protocol, it is proposed to study the optical imaging features of healthy human skin and nevi and the evaluation of usability. We propose to recruit 60 subjects for such a trial. Healthy volunteers will be approached and consented to this protocol. The volunteers will be imaged.

Conditions: Healthy Skin, Nevus
Being tested: ApolloVue® S100 Image System
Keywords: Optical Coherence Tomograohy, Healthy volunteer, Non-invasive image system, Cellular level resolution, Full-Field OCT, Nevus
Medical subject headings: Nevus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ApolloVue® S100 Image SystemDevice
The device is an in vivo non-invasive optical coherence tomography and will be used to obtain at least 3 quality OCT images of B-scan (cross-section) and E-scan (en face) with 4 depths for each skin site respectively for each skin site. There is a total of 6 skin sites.

Study groups in NCT04406454
Study group	Role	What they receive
Heathy volunteers		Patients has healthy skin at 5 anatomical locations including face, back, dorsal forearm, volar forearm, calf and at least a nevus without superficial scales and crusting. Receives: Device: ApolloVue® S100 Image System

What is being measured

The primary outcome is the main question the study is designed to answer.

Determine the average scanning success rate of obtaining at least 3 quality OCT images of B-scan and E-scan with 4 depths for each skin site, respectively.
- Scanning efficiency = total number of quality images/total number of images obtained x 100%.
- Scanning efficiency ≧ 50%
Measured: 2 years
Evaluator identification of each feature will be assessed (number of correctly identified feature/number of total features x 100%).
The purpose of this evaluation is to validate that the ApolloVue® S100 Image System delivers non-invasive skin image features.
Required features will be analyzed for each group, including age, skin type and anatomical location.
The features need to meet the following requirement in each 500 x 400 µm2 image for B-scan and in each 500 x 500 μm2 image for E-scan.
1. Identification of keratinocyte in ≧ 80% of images (B-scan only)
2. Identification of stratum corneum in ≧ 80% of images
3. Identification of epidermis in ≧ 80% of images
4. Identification of dermis in ≧ 80% of images
5. Identification of EDJ in ≧ 80% of images
6. Identification of collagen in ≧ 80% of images (B-scan only)
7. Identification of melanin in ≧ 80% of images
Measured: 2 years
Determine time required to obtain at least 3 quality OCT images of B-scan and E-scan with 4 depths for each skin site, respectively.
Time required < 20 minutes for each body site except for nevus.
Time required < 40 minutes for a nevus including image guiding.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 20208 Feb 2022

First posted28 May 2020
Study start6 Jul 2020
Primary completion1 Sep 2021
Study completion8 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Healthy SkinStudies of the same condition, open and under way.
More trials run by Taipei Veterans General Hospital, TaiwanThe 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: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04406454
Sponsor's protocol ID: 2020-01-001A
Status last verified: Nov 2023
First submitted: 24 May 2020
Last updated: 14 Nov 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.
PubMed 3377516
Adabi S, Hosseinzadeh M, Noei S, Conforto S, Daveluy S, Clayton A, Mehregan D, Nasiriavanaki M. Universal in vivo Textural Model for Human Skin based on Optical Coherence Tomograms. Sci Rep. 2017 Dec 20;7(1):17912. doi: 10.1038/s41598-017-17398-8.
PubMed 29263332

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Skin trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Application of Non-invasive and Cellular Level Resolution Fullfield Optical Coherence Tomography: Establishment and Analysis of Subcutaneous Cellular Level Image Database of Anatomical Locations in Healthy Volunteers and Evaluation of Usability
ClinicalTrials.gov ID: NCT04406454
Acronym / sponsor ID: 2020-01-001A
Conditions: Healthy Skin, Nevus
Keywords: Optical Coherence Tomograohy, Healthy volunteer, Non-invasive image system, Cellular level resolution, Full-Field OCT, Nevus
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Taipei Veterans General Hospital, TaiwanOther government
Collaborators: Apollo Medical Optics, Ltd
Study start: 6 Jul 2020 (actual)
Primary completion: 1 Sep 2021 (actual)
Study completion: 8 Feb 2022 (actual)
First posted: 28 May 2020 (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.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Heathy volunteers	–	Device: ApolloVue® S100 Image SystemPatients has healthy skin at 5 anatomical locations including face, back, dorsal forearm, volar forearm, calf and at least a nevus without superficial scales and crusting.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: The population from healthy volunteers will be selected.

Key inclusion criteria (12 listed)

All age will be recruited.
Both genders will be recruited.
All skin types will be recruited. Skin type I-VI (Fitzpatrick scale)
Has healthy skin at 5 anatomical locations including face, back, dorsal forearm, volar forearm, and calf.
Has at least a nevus without superficial scales and crusting

Key exclusion criteria (4 listed)

Individuals who have a systemic skin disorder.
Individuals who have a history of severe skin condition
Individuals with surgeries/cosmetic surgeries/micro cosmetic surgery (eg. cosmetic injections and/or laser etc.) on healthy skin at the 5 anatomical locations and nevi (see inclusion criteria 5) in last 12 months and a physician determine the surgery will affect outcome of the OCT images.
Not willing to cooperate with methods and related procedures of this trial/study

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 SystemThe device is an in vivo non-invasive optical coherence tomography and will be used to obtain at least 3 quality OCT images of B-scan (cross-section) and E-scan (en face) with 4 depths for each skin site respectively for each skin site. There is a total of 6 skin sites.	Device	Heathy volunteers

Primary outcome

Determine the average scanning success rate of obtaining at least 3 quality OCT images of B-scan and E-scan with 4 depths for each skin site, respectively.
Time frame: 2 years
* Scanning efficiency = total number of quality images/total number of images obtained x 100%. * Scanning efficiency ≧ 50%
Evaluator identification of each feature will be assessed (number of correctly identified feature/number of total features x 100%).
Time frame: 2 years
The purpose of this evaluation is to validate that the ApolloVue® S100 Image System delivers non-invasive skin image features. Required features will be analyzed for each group, including age, skin type and anatomical location. The features need to meet the following requirement in each 500 x 400 µm2 image for B-scan and in each 500 x 500 μm2 image for E-scan. A. Identification of keratinocyte in ≧ 80% of images (B-scan only) B. Identification of stratum corneum in ≧ 80% of images C. Identification of epidermis in ≧ 80% of images D. Identification of dermis in ≧ 80% of images E. Identification of EDJ in ≧ 80% of images F. Identification of collagen in ≧ 80% of images (B-scan only) G. Identification of melanin in ≧ 80% of images
Determine time required to obtain at least 3 quality OCT images of B-scan and E-scan with 4 depths for each skin site, respectively.
Time frame: 2 years
Time required < 20 minutes for each body site except for nevus. Time required < 40 minutes for a nevus including image guiding.

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 14 Nov 2023.
Background: PubMed 3377516Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.
Background: PubMed 29263332Adabi S, Hosseinzadeh M, Noei S, Conforto S, Daveluy S, Clayton A, Mehregan D, Nasiriavanaki M. Universal in vivo Textural Model for Human Skin based on Optical Coherence Tomograms. Sci Rep. 2017 Dec 20;7(1):17912. doi: 10.1038/s41598-017-17398-8.
Individual participant dataSharing planned: Undecided

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Active, not recruitingPhase 1
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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.

Ding-Dar Lee, M.D., Ph. D principal investigator

Taipei Veterans General Hospital, Taiwan

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 Healthy Skin and Nevus, run by Taipei Veterans General Hospital, Taiwan 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 12 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 14 Nov 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?

Determine the average scanning success rate of obtaining at least 3 quality OCT images of B-scan and E-scan with 4 depths for each skin site, respectively. (time frame: 2 years). The study lists 3 primary outcomes in all. 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 NCT04406454, which also lists 2 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 14 Nov 2023.