Healthy VolunteerNOVAS-HFUSNCT06000163
Normal Reference Values in Han Adults of Skin Thickness and Blood Flow by High-frequency Ultrasound
An observational study of Healthy Volunteer and Skin, run by First Hospital of China Medical University.
Trial summary
In recent years, high-frequency ultrasound has become a new non-invasive tool for the diagnosis of skin diseases, aesthetic medicine and preoperative and postoperative evaluation due to its higher resolution. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Skin
- What is being tested?
- high-frequency ultrasound
- Type of treatment
- Medical device
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 30 Sep 2025
- 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 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese healthy Han adults
Who may be able to join
- Han nationality;
- Ages 18-79;
- Normal blood pressure (139-90/89-60mmHg);
- Body mass index < 30 kg/m2;
- Blood routine, fasting blood glucose, blood lipid, liver and kidney function, electrocardiogram were normal;
- No history of skin disease, connective tissue disease, cardiovascular disease, diabetes, severe liver and kidney dysfunction.
- No history of drug use affecting cardiovascular system.
Who cannot join
- People with skin diseases (such as eczema, psoriasis, scleroderma, etc.);
- Any skin disease at the test site (such as dermatitis, acne, breakages, previous skin lesions, etc.);
- chronic systemic diseases;
- Use corticosteroid drugs or immunosuppressants;
- Pregnant or lactating women;
- People who have been exposed to ultraviolet radiation for a long time or have a history of sun exposure within 3 months;
- The examined skin area has been previously treated with other methods;
- Unable to cooperate with the inspector.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Normal Reference Values in Han Adults of Skin Thickness and Blood Flow by High-frequency Ultrasound: a Multicenter Study in China
In recent years, high-frequency ultrasound has become a new non-invasive tool for the diagnosis of skin diseases, aesthetic medicine and preoperative and postoperative evaluation due to its higher resolution. The purpose of this multi-center Study is to establish the normal reference values of skin thickness and blood flow parameters by high-frequency ultrasound in Chinese Han adults, and to explore the influencing factors, so as to provide quantitative reference for the evaluation of facial skin aging degree and cosmetic treatment.
Read the detailed description
The skin is the body's largest organ and acts as a protective, permeable barrier against pathogen invasion and against chemical and physical attacks. Long-term exposure to solar ultraviolet radiation is a major factor in exogenous skin aging. With the gradual improvement of living standards and the development of medical cosmetology technology, Chinese consumers have gradually increased their acceptance of cosmetology consumption. Facial skin, as one of the important indicators of "beauty", has obviously received the attention of cosmetic surgeons and dermatologists. Skin thickness is one of the important indicators of facial aging. However, different gender, different parts of the skin thickness is very different, especially the facial skin, the thickness of the epidermis, dermis is different, and the facial plastic surgery, injection treatment, photoelectric treatment has a close relationship. In addition, the dermis is rich in blood vessels, especially in its deep layers, which play an important role in the nutritional support of tissues and homeostasis of the internal environment. With the increase of age, the degree of dermal vascularization decreases, which is also one of the factors affecting skin aging. Therefore, in aesthetic medicine, more accurate quantitative evaluation of skin thickness and blood flow rather than simple subjective evaluation is very important.
Ultrasound is a non-invasive imaging technique widely used in clinic. In recent years, with the development of ultrasound technology, the frequency of ultrasonic probes has been increasing. Because of its higher resolution, high-frequency ultrasound can clearly display the layer and structure of the skin, and achieve accurate measurement of skin thickness and evaluation of dermal blood flow. High-frequency ultrasound has become a new non-invasive tool for the diagnosis of skin diseases, aesthetic medicine and preoperative and postoperative evaluation. The purpose of this multi-center Study is to establish the normal reference values of skin thickness and blood flow parameters by high-frequency ultrasound in Chinese Han adults, and to explore the influencing factors, so as to provide quantitative reference for the evaluation of facial skin aging degree and cosmetic treatment.
- Conditions
- Healthy Volunteer, Skin
- Being tested
- high-frequency ultrasound
- Keywords
- skin thickness, dermal blood flow, high-frequency ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-frequency ultrasoundDevice
The volunteers will be given a high-frequency ultrasound examination of the skin, which is non-invasive, and skin thickness and blood flow parameters will be measured.
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermal thickness
Dermal thickness reflects the change in skin structure and can be used to assess skin aging.
Measured: 1 day
Secondary outcomes (1)
Blood flow velocity of dermal artery
Blood flow velocity of dermal artery reflects the hemodynamic changes of skin and can be used for early evaluation of skin aging.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunyan Ma, First Hospital of China Medical University
- Investigators
- Lixin Jiang, PHD, Principal investigator, Shanghai Jiao Tong University School of MedicineXinhua Ye, PHD, Principal investigator, The First Affiliated Hospital with Nanjing Medical UniversityWeiDong Ren, PHD, Principal investigator, Shengjing HospitalXin Guan, PHD, Principal investigator, Tianjin Chest HospitalHongning Yin, PHD, Principal investigator, The Second Hospital of Hebei Medical UniversityXiaoshan Zhang, PHD, Principal investigator, The Affiliated Hospital of Inner Mongolia Medical UniversityYuhong Zhang, PHD, Principal investigator, The Second Affiliated Hospital of Dalian Medical UniversityQingxiong Yue, PHD, Principal investigator, Dalian Municipal Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000163
- Sponsor's protocol ID
- NOVAS-HFUS-01
- Acronym
- NOVAS-HFUS
- Status last verified
- Aug 2023
- First submitted
- 23 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Reference Values in Han Adults of Skin Thickness and Blood Flow by High-frequency Ultrasound: a Multicenter Study in China
- ClinicalTrials.gov ID
- NCT06000163
- Acronym / sponsor ID
- NOVAS-HFUS / NOVAS-HFUS-01
- Conditions
- Healthy Volunteer, Skin
- Keywords
- skin thickness, dermal blood flow, high-frequency ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 21 Aug 2023 (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.
In recent years, high-frequency ultrasound has become a new non-invasive tool for the diagnosis of skin diseases, aesthetic medicine and preoperative and postoperative evaluation due to its higher resolution. The purpose of this multi-center Study is to establish the normal reference values of skin thickness and blood flow parameters by high-frequency ultrasound in Chinese Han adults, and to explore the influencing factors, so as to provide quantitative reference for the evaluation of facial skin aging degree and cosmetic treatment.
Detailed description
The skin is the body's largest organ and acts as a protective, permeable barrier against pathogen invasion and against chemical and physical attacks. Long-term exposure to solar ultraviolet radiation is a major factor in exogenous skin aging. With the gradual improvement of living standards and the development of medical cosmetology technology, Chinese consumers have gradually increased their acceptance of cosmetology consumption. Facial skin, as one of the important indicators of "beauty", has obviously received the attention of cosmetic surgeons and dermatologists. Skin thickness is one of the important indicators of facial aging. However, different gender, different parts of the skin thickness is very different, especially the facial skin, the thickness of the epidermis, dermis is different, and the facial plastic surgery, injection treatment, photoelectric treatment has a close relationship. In addition, the dermis is rich in blood vessels, especially in its deep layers, which play an important role in the nutritional support of tissues and homeostasis of the internal environment. With the increase of age, the degree of dermal vascularization decreases, which is also one of the factors affecting skin aging. Therefore, in aesthetic medicine, more accurate quantitative evaluation of skin thickness and blood flow rather than simple subjective evaluation is very important.
Ultrasound is a non-invasive imaging technique widely used in clinic. In recent years, with the development of ultrasound technology, the frequency of ultrasonic probes has been increasing. Because of its higher resolution, high-frequency ultrasound can clearly display the layer and structure of the skin, and achieve accurate measurement of skin thickness and evaluation of dermal blood flow. High-frequency ultrasound has become a new non-invasive tool for the diagnosis of skin diseases, aesthetic medicine and preoperative and postoperative evaluation. The purpose of this multi-center Study is to establish the normal reference values of skin thickness and blood flow parameters by high-frequency ultrasound in Chinese Han adults, and to explore the influencing factors, so as to provide quantitative reference for the evaluation of facial skin aging degree and cosmetic treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese healthy Han adults
Key inclusion criteria (7 listed)
- Han nationality;
- Ages 18-79;
- Normal blood pressure (139-90/89-60mmHg);
- Body mass index < 30 kg/m2;
- Blood routine, fasting blood glucose, blood lipid, liver and kidney function, electrocardiogram were normal;
Key exclusion criteria (8 listed)
- People with skin diseases (such as eczema, psoriasis, scleroderma, etc.);
- Any skin disease at the test site (such as dermatitis, acne, breakages, previous skin lesions, etc.);
- chronic systemic diseases;
- Use corticosteroid drugs or immunosuppressants;
- Pregnant or lactating women;
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 |
|---|---|---|
| high-frequency ultrasoundThe volunteers will be given a high-frequency ultrasound examination of the skin, which is non-invasive, and skin thickness and blood flow parameters will be measured. | Device | – |
Primary outcome
Dermal thickness
Time frame: 1 day
Dermal thickness reflects the change in skin structure and can be used to assess skin aging.
1 secondary outcome
Blood flow velocity of dermal artery
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- 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.
Lixin Jiang, PHD principal investigator
Shanghai Jiao Tong University School of Medicine
Xinhua Ye, PHD principal investigator
The First Affiliated Hospital with Nanjing Medical University
WeiDong Ren, PHD principal investigator
Shengjing Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer and Skin, run by First Hospital of China Medical University.
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 7 inclusion and 8 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 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Chunyan Ma, PHD (13998816448, cmu1h_mcy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermal thickness (time frame: 1 day). 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 2023.