NCT06000163

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
540

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

July 23, 2023

Last Update Submit

August 12, 2023

Conditions

Keywords

skin thicknessdermal blood flowhigh-frequency ultrasound

Outcome Measures

Primary Outcomes (1)

  • Dermal thickness

    Dermal thickness reflects the change in skin structure and can be used to assess skin aging.

    1 day

Secondary Outcomes (1)

  • Blood flow velocity of dermal artery

    1 day

Interventions

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.

Eligibility Criteria

Age18 Years - 79 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Chinese healthy Han adults

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Lixin Jiang, PHD

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR
  • Xinhua Ye, PHD

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR
  • WeiDong Ren, PHD

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR
  • Xin Guan, PHD

    Tianjin Chest Hospital

    PRINCIPAL INVESTIGATOR
  • Hongning Yin, PHD

    The Second Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR
  • Xiaoshan Zhang, PHD

    The Affiliated Hospital of Inner Mongolia Medical University

    PRINCIPAL INVESTIGATOR
  • Yuhong Zhang, PHD

    The Second Affiliated Hospital of Dalian Medical University

    PRINCIPAL INVESTIGATOR
  • Qingxiong Yue, PHD

    Dalian Municipal Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunyan Ma, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Cardiovascular Ultrasound

Study Record Dates

First Submitted

July 23, 2023

First Posted

August 21, 2023

Study Start

September 1, 2023

Primary Completion

September 30, 2024

Study Completion

September 30, 2025

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share