Healthy Participants With Different Skin Types and Different AgesNCT01980264
Harmonics-based in Vivo Optical Virtual Biopsy
A study testing Harmonic Generation Microscopy in people with Healthy Participants With Different Skin Types and Different Ages and Diseased Participants With Different Skin Types and Different Ages, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The research aims to study the molecules and structures in human skin by the image formation of harmonic-based in vivo optical virtual biopsy. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants With Different Skin Types and Different Ages, Diseased Participants With Different Skin Types and Different Ages, Participants Suffered From Diabetes With Different Skin Types and Different Ages
- What is being tested?
- Harmonic Generation Microscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Aug 2009to 31 Dec 2025
- Phase
- Interventional
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers of different skin colors and different ages
- patients with suspected melanoma
- patients with suspected basal cell carcinoma or squamous cell carcinoma
- patients with diabetes mellitus
Who cannot join
- volunteers have infectious disease
- volunteers' skin have been infected with ulceration
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Dermatology, National Taiwan University Hospital and College of Medicine, National Taiwan University
Taipei, 10002
About this study
The research aims to study the molecules and structures in human skin by the image formation of harmonic-based in vivo optical virtual biopsy.
Read the detailed description
In the research, the investigators use the Cr:forsterite laser as the light source, and utilize the nonlinear optical microscopic system to observe human skin via in vivo detection. In this study, images of human skin tissue will be acquired by virtual section to truly evaluate the feasibility of this system in clinical application.
This research intends to conduct the following research:
- To study the feasibility of this technology to observe melanin in the skin: As melanin is THG-bright, the technology will help to explore the distribution and change of melanin in the skin.
- To study the capability of this technology in the early diagnosis of skin cancers, including melanoma, basal cell carcinoma, and squamous cell carcinoma: By obtaining skin images of healthy and diseased patients, we can establish an image database of normal and cancerous skin in different atages, and evaluate the efficacy of this technology for early diagnosis of skin malignancy in the future.
- To study the ability of this technology to observe and analyze the degree of skin aging: Optical sectioning of human skin in a non-invasive in vivo manner can be used to detect the microscopic changes of skin aging and solar damage, and to find out the indicators of skin aging, so as to be used in the future to assist the therapeutic analysis of anti-skin aging treatment.
- To study the ability of this technology to observe peripheral vasculopathy and molecular changes of microvascular structures in diabetic patients: Perform microscopic imaging on healthy and diabetes patients' skin to observe effects of structures and molecules in their skin, such as peripheral vasculopathy in diabetic patients, and the status of disease parameters, with a view to find the cause of peripheral vascular lesions and other biological information.
- Conditions
- Healthy Participants With Different Skin Types and Different Ages, Diseased Participants With Different Skin Types and Different Ages, Participants Suffered From Diabetes With Different Skin Types and Different Ages
- Being tested
- Harmonic Generation Microscopy
- Keywords
- Healthy human skin, Skin cancer, Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma, Diabetes mellitus
- Medical subject headings
- Skin Neoplasms, Melanoma, Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmonic Generation MicroscopyDevice
Also called HGM
Harmonic Generation Microscopy is a nonlinear optical microscopy.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic imaging | Experimental | Harmonic Generation Microscopy Receives: Device: Harmonic Generation Microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To noninvasively provide real-time imaging of cutaneous histopathology and molecular changes.
To observe some analyzed molecule (melanin density, HbA1c density, collagen density, etc) \& structure (cell size, cell height, height of rete ridges, layer thickness, etc) parameters for different skin types \& age groups. (the information above can be observed in the nonlinear images) (Cell or molecule density is defined as the cell or molecule numbers in the specific image area) (Structure can be observed and reconstructed via multiple z-depth images)
Measured: one year
Secondary outcomes (1)
To provide a diagnostic tool for diseases.
To diagnose if the analyzed pathological-related parameters (the parameters can be observed in the nonlinear images) (the pathological-related information includes cell shape, cell size, and molecular distribution (ex: chromatin, HbA1c, etc) in each single cell, etc) from Harmonic-based in Vivo Optical Virtual Biopsy can distinguish melanoma, basal cell carcinoma, squamous cell carcinoma, high \& low HbA1c groups from control.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study start5 Aug 2009
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participants With Different Skin Types and Different AgesStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Sponsor
- Investigators
- Yi-Hua Liao, Doctoral, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980264
- Sponsor's protocol ID
- 200903064D
- Status last verified
- Jun 2024
- First submitted
- 3 Nov 2013
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmonics-based in Vivo Optical Virtual Biopsy
- ClinicalTrials.gov ID
- NCT01980264
- Acronym / sponsor ID
- 200903064D
- Conditions
- Healthy Participants With Different Skin Types and Different Ages, Diseased Participants With Different Skin Types and Different Ages, Participants Suffered From Diabetes With Different Skin Types and Different Ages
- Keywords
- Healthy human skin, Skin cancer, Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma, Diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- 5 Aug 2009 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Nov 2013 (estimated)
- 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.
The research aims to study the molecules and structures in human skin by the image formation of harmonic-based in vivo optical virtual biopsy.
Detailed description
In the research, the investigators use the Cr:forsterite laser as the light source, and utilize the nonlinear optical microscopic system to observe human skin via in vivo detection. In this study, images of human skin tissue will be acquired by virtual section to truly evaluate the feasibility of this system in clinical application.
This research intends to conduct the following research:
- To study the feasibility of this technology to observe melanin in the skin: As melanin is THG-bright, the technology will help to explore the distribution and change of melanin in the skin.
- To study the capability of this technology in the early diagnosis of skin cancers, including melanoma, basal cell carcinoma, and squamous cell carcinoma: By obtaining skin images of healthy and diseased patients, we can establish an image database of normal and cancerous skin in different atages, and evaluate the efficacy of this technology for early diagnosis of skin malignancy in the future.
- To study the ability of this technology to observe and analyze the degree of skin aging: Optical sectioning of human skin in a non-invasive in vivo manner can be used to detect the microscopic changes of skin aging and solar damage, and to find out the indicators of skin aging, so as to be used in the future to assist the therapeutic analysis of anti-skin aging treatment.
- To study the ability of this technology to observe peripheral vasculopathy and molecular changes of microvascular structures in diabetic patients: Perform microscopic imaging on healthy and diabetes patients' skin to observe effects of structures and molecules in their skin, such as peripheral vasculopathy in diabetic patients, and the status of disease parameters, with a view to find the cause of peripheral vascular lesions and other biological information.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic imaging | Experimental | Device: Harmonic Generation MicroscopyHarmonic Generation Microscopy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- healthy volunteers of different skin colors and different ages
- patients with suspected melanoma
- patients with suspected basal cell carcinoma or squamous cell carcinoma
- patients with diabetes mellitus
Key exclusion criteria (2 listed)
- volunteers have infectious disease
- volunteers' skin have been infected with ulceration
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 |
|---|---|---|
| Harmonic Generation MicroscopyAlso: HGMHarmonic Generation Microscopy is a nonlinear optical microscopy. | Device | Diagnostic imaging |
Primary outcome
To noninvasively provide real-time imaging of cutaneous histopathology and molecular changes.
Time frame: one year
To observe some analyzed molecule (melanin density, HbA1c density, collagen density, etc) \& structure (cell size, cell height, height of rete ridges, layer thickness, etc) parameters for different skin types \& age groups. (the information above can be observed in the nonlinear images) (Cell or molecule density is defined as the cell or molecule numbers in the specific image area) (Structure can be observed and reconstructed via multiple z-depth images)
1 secondary outcome
To provide a diagnostic tool for diseases.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- UFO-LabLink provided by the sponsor.
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.
Yi-Hua Liao, Doctoral principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Harmonic Generation Microscopy in people with Healthy Participants With Different Skin Types and Different Ages and Diseased Participants With Different Skin Types and Different Ages, run by National Taiwan University 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Hua Liao, Doctoral ((02)23123456 ext. 263155, yihualiao@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To noninvasively provide real-time imaging of cutaneous histopathology and molecular changes. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2024.