xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06000163</url>
    </required_header>
    <id_info>
      <org_study_id>NOVAS-HFUS-01</org_study_id>
      <nct_id>NCT06000163</nct_id>
    </id_info>
    <brief_title>Normal Reference Values in Han Adults of Skin Thickness and Blood Flow by High-frequency Ultrasound</brief_title>
    <acronym>NOVAS-HFUS</acronym>
    <official_title>Normal Reference Values in Han Adults of Skin Thickness and Blood Flow by High-frequency Ultrasound: a Multicenter Study in China</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Hospital of China Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Hospital of China Medical University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In recent years, high-frequency ultrasound has become a new non-invasive tool for the&#xD;
        diagnosis of skin diseases, aesthetic medicine and preoperative and postoperative evaluation&#xD;
        due to its higher resolution. The purpose of this multi-center Study is to establish the&#xD;
        normal reference values of skin thickness and blood flow parameters by high-frequency&#xD;
        ultrasound in Chinese Han adults, and to explore the influencing factors, so as to provide&#xD;
        quantitative reference for the evaluation of facial skin aging degree and cosmetic treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The skin is the body's largest organ and acts as a protective, permeable barrier against&#xD;
        pathogen invasion and against chemical and physical attacks. Long-term exposure to solar&#xD;
        ultraviolet radiation is a major factor in exogenous skin aging. With the gradual improvement&#xD;
        of living standards and the development of medical cosmetology technology, Chinese consumers&#xD;
        have gradually increased their acceptance of cosmetology consumption. Facial skin, as one of&#xD;
        the important indicators of &quot;beauty&quot;, has obviously received the attention of cosmetic&#xD;
        surgeons and dermatologists. Skin thickness is one of the important indicators of facial&#xD;
        aging. However, different gender, different parts of the skin thickness is very different,&#xD;
        especially the facial skin, the thickness of the epidermis, dermis is different, and the&#xD;
        facial plastic surgery, injection treatment, photoelectric treatment has a close&#xD;
        relationship. In addition, the dermis is rich in blood vessels, especially in its deep&#xD;
        layers, which play an important role in the nutritional support of tissues and homeostasis of&#xD;
        the internal environment. With the increase of age, the degree of dermal vascularization&#xD;
        decreases, which is also one of the factors affecting skin aging. Therefore, in aesthetic&#xD;
        medicine, more accurate quantitative evaluation of skin thickness and blood flow rather than&#xD;
        simple subjective evaluation is very important.&#xD;
  &#xD;
        Ultrasound is a non-invasive imaging technique widely used in clinic. In recent years, with&#xD;
        the development of ultrasound technology, the frequency of ultrasonic probes has been&#xD;
        increasing. Because of its higher resolution, high-frequency ultrasound can clearly display&#xD;
        the layer and structure of the skin, and achieve accurate measurement of skin thickness and&#xD;
        evaluation of dermal blood flow. High-frequency ultrasound has become a new non-invasive tool&#xD;
        for the diagnosis of skin diseases, aesthetic medicine and preoperative and postoperative&#xD;
        evaluation. The purpose of this multi-center Study is to establish the normal reference&#xD;
        values of skin thickness and blood flow parameters by high-frequency ultrasound in Chinese&#xD;
        Han adults, and to explore the influencing factors, so as to provide quantitative reference&#xD;
        for the evaluation of facial skin aging degree and cosmetic treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Dermal thickness</measure>
      <time_frame>1 day</time_frame>
      <description>Dermal thickness reflects the change in skin structure and can be used to assess skin aging.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Blood flow velocity of dermal artery</measure>
      <time_frame>1 day</time_frame>
      <description>Blood flow velocity of dermal artery reflects the hemodynamic changes of skin and can be used for early evaluation of skin aging.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">540</enrollment>
    <condition>Healthy Volunteer</condition>
    <condition>Skin</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>high-frequency ultrasound</intervention_name>
      <description>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.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Chinese healthy Han adults&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Han nationality;&#xD;
  &#xD;
            2. Ages 18-79;&#xD;
  &#xD;
            3. Normal blood pressure (139-90/89-60mmHg);&#xD;
  &#xD;
            4. Body mass index &lt; 30 kg/m2;&#xD;
  &#xD;
            5. Blood routine, fasting blood glucose, blood lipid, liver and kidney function,&#xD;
               electrocardiogram were normal;&#xD;
  &#xD;
            6. No history of skin disease, connective tissue disease, cardiovascular disease,&#xD;
               diabetes, severe liver and kidney dysfunction.&#xD;
  &#xD;
            7. No history of drug use affecting cardiovascular system.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. People with skin diseases (such as eczema, psoriasis, scleroderma, etc.);&#xD;
  &#xD;
            2. Any skin disease at the test site (such as dermatitis, acne, breakages, previous skin&#xD;
               lesions, etc.);&#xD;
  &#xD;
            3. chronic systemic diseases;&#xD;
  &#xD;
            4. Use corticosteroid drugs or immunosuppressants;&#xD;
  &#xD;
            5. Pregnant or lactating women;&#xD;
  &#xD;
            6. People who have been exposed to ultraviolet radiation for a long time or have a&#xD;
               history of sun exposure within 3 months;&#xD;
  &#xD;
            7. The examined skin area has been previously treated with other methods;&#xD;
  &#xD;
            8. Unable to cooperate with the inspector.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>79 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lixin Jiang, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shanghai Jiao Tong University School of Medicine</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Xinhua Ye, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>WeiDong Ren, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shengjing Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Xin Guan, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tianjin Chest Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hongning Yin, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Second Hospital of Hebei Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Xiaoshan Zhang, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Affiliated Hospital of Inner Mongolia Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yuhong Zhang, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Second Affiliated Hospital of Dalian Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Qingxiong Yue, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dalian Municipal Central Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chunyan Ma, PHD</last_name>
      <phone>13998816448</phone>
      <email>cmu1h_mcy@126.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>First Hospital of China Medical University</investigator_affiliation>
      <investigator_full_name>Chunyan Ma</investigator_full_name>
      <investigator_title>Chief of Cardiovascular Ultrasound</investigator_title>
    </responsible_party>
    <keyword>skin thickness</keyword>
    <keyword>dermal blood flow</keyword>
    <keyword>high-frequency ultrasound</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>May 28, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT06000163/Prot_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>May 28, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT06000163/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06000163
  org study id: NOVAS-HFUS-01
  nct id: NCT06000163
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Dermal thickness
  time frame: 1 day
  description: Dermal thickness reflects the change in skin structure and can be used to assess skin aging.
  measure: Blood flow velocity of dermal artery
  time frame: 1 day
  description: Blood flow velocity of dermal artery reflects the hemodynamic changes of skin and can be used for early evaluation of skin aging.
  intervention type: Device
  intervention name: high-frequency ultrasound
  description: 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.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  gender based: Yes
  minimum age: 18 Years
  maximum age: 79 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lixin Jiang, PHD
  role: Principal Investigator
  affiliation: Shanghai Jiao Tong University School of Medicine
  last name: Xinhua Ye, PHD
  role: Principal Investigator
  affiliation: The First Affiliated Hospital with Nanjing Medical University
  last name: WeiDong Ren, PHD
  role: Principal Investigator
  affiliation: Shengjing Hospital
  last name: Xin Guan, PHD
  role: Principal Investigator
  affiliation: Tianjin Chest Hospital
  last name: Hongning Yin, PHD
  role: Principal Investigator
  affiliation: The Second Hospital of Hebei Medical University
  last name: Xiaoshan Zhang, PHD
  role: Principal Investigator
  affiliation: The Affiliated Hospital of Inner Mongolia Medical University
  last name: Yuhong Zhang, PHD
  role: Principal Investigator
  affiliation: The Second Affiliated Hospital of Dalian Medical University
  last name: Qingxiong Yue, PHD
  role: Principal Investigator
  affiliation: Dalian Municipal Central Hospital
  last name: Chunyan Ma, PHD
  phone: 13998816448
  email: cmu1h_mcy@126.com
  responsible party type: Principal Investigator
  investigator affiliation: First Hospital of China Medical University
  investigator full name: Chunyan Ma
  investigator title: Chief of Cardiovascular Ultrasound
  sharing ipd: No
  provided document: 
  provided document: 