Normal Reference Values in Han Adults of Skin Thickness and Blood Flow by High-frequency Ultrasound

NCT ID: NCT06000163

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 540 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-09-30

Brief 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. 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.

Conditions

Healthy Volunteer; Skin

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

high-frequency ultrasound

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Han nationality;

2. Ages 18-79;

3. Normal blood pressure (139-90/89-60mmHg);

4. Body mass index < 30 kg/m2;

5. Blood routine, fasting blood glucose, blood lipid, liver and kidney function, electrocardiogram were normal;

6. No history of skin disease, connective tissue disease, cardiovascular disease, diabetes, severe liver and kidney dysfunction.

7. No history of drug use affecting cardiovascular system.

Exclusion Criteria

1. People with skin diseases (such as eczema, psoriasis, scleroderma, etc.);

2. Any skin disease at the test site (such as dermatitis, acne, breakages, previous skin lesions, etc.);

3. chronic systemic diseases;

4. Use corticosteroid drugs or immunosuppressants;

5. Pregnant or lactating women;

6. People who have been exposed to ultraviolet radiation for a long time or have a history of sun exposure within 3 months;

7. The examined skin area has been previously treated with other methods;

8. Unable to cooperate with the inspector.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Hospital of China Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chunyan Ma

Chief of Cardiovascular Ultrasound

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lixin Jiang, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Xinhua Ye, PHD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

WeiDong Ren, PHD

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Xin Guan, PHD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Chest Hospital

Hongning Yin, PHD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Hebei Medical University

Xiaoshan Zhang, PHD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Inner Mongolia Medical University

Yuhong Zhang, PHD

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Dalian Medical University

Qingxiong Yue, PHD

Role: PRINCIPAL_INVESTIGATOR

Dalian Municipal Central Hospital

Central Contacts

Chunyan Ma, PHD

Role: CONTACT

cmu1h_mcy@126.com

13998816448

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NOVAS-HFUS-01

Identifier Type: -

Identifier Source: org_study_id