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/NCT05994781</url>
    </required_header>
    <id_info>
      <org_study_id>G2205</org_study_id>
      <nct_id>NCT05994781</nct_id>
    </id_info>
    <brief_title>A Prospective Researcher-led Clinical Study of Neopep-S-based EasyDew MD Regen Cream</brief_title>
    <official_title>A Prospective Researcher-led Clinical Study to Evaluate the Effectiveness and Safety of the Application of Neopep-S-based Easy Dew MD Regen Cream in Partial Layer Skin Transplantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eun-ji Kim</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CGBio Inc.</source>
    <oversight_info>
      <has_dmc>No</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>
        This clinical study is conducted prospectively for 3 months after medical device treatment.&#xD;
  &#xD;
        It is a comparative clinical study of the leading control group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Subjects need tissue transplantation to repair skin defects, so partial layer skin&#xD;
        transplantation is performed. After proceeding, the patient is no longer subject to&#xD;
        exudation. Subjects (and/or legal representatives) have agreed in writing to participate in&#xD;
        the clinical study Perform a post-screening test.&#xD;
  &#xD;
        Evaluating the screening test results, meeting the selection criteria, and meeting the&#xD;
        exclusion criteria those who do not are registered for clinical research.&#xD;
  &#xD;
        In the case of the study group among the subjects of the clinical study, whether partial&#xD;
        layer skin transplantation was performed or not, Apply an appropriate amount of EasyDew MD&#xD;
        Regen Cream twice a day (morning and evening) and can be absorbed well.&#xD;
  &#xD;
        The control group is a non-treatment group, and for 3 months after the procedure. General&#xD;
        moisturizers that have been used or will be used are available. The control group's&#xD;
        Moisturizer is recommended twice a day (morning and evening) on whether skin grafts are&#xD;
        collected or not Apply and allow good absorption. After applying medical devices and&#xD;
        moisturizers for clinical research, the progress will be observed for 3 months, Subjects are&#xD;
        a screening visit (Visit1), the day of medical device application (Visit2), and after medical&#xD;
        device application.&#xD;
  &#xD;
        Visit the research institution regularly for one month (Visit3) and three months after&#xD;
        application (Visit4) for validity and it will be evaluated for safety.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 11, 2022</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">June 27, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>TEWL score</measure>
      <time_frame>Before, after one month after application, 3 month after application</time_frame>
      <description>Transepidermal water loss score/ No range of upper and lower score, the lower is best</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Investigator Global Assessment scale</measure>
      <time_frame>Before, after one month after application, 3 month after application</time_frame>
      <description>Assess the patient's overall condition /lowest 0 score ( best score) to highest 30 score( worst score)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dermatology Life Quality Index</measure>
      <time_frame>Before, after one month after application, 3 month after application</time_frame>
      <description>Assess patient quality of life / lowest 0 score ( best score) to highest 4 score( worst score)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>itching scale</measure>
      <time_frame>Before, after one month after application, 3 month after application</time_frame>
      <description>Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst score)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VSS</measure>
      <time_frame>Before, after one month after application, 3 month after application</time_frame>
      <description>Vancouver Scar Scale/ No range of upper and lower score, the lower is best</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Skin Lesion</condition>
    <arm_group>
      <arm_group_label>No treatment</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group is a non-treatment group, and for 3 months after the procedure, general moisturizers that have been used or will be used are available.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the case of the study group among the subjects of the clinical study, The experimental group apply an appropriate amount of EasyDew MD Regen Cream twice a day (morning and evening) and can be absorbed well.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>EasyDew MD regen cram</intervention_name>
      <description>No intervention</description>
      <arm_group_label>Treatment</arm_group_label>
      <other_name>No treatment</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adults over the age of 19&#xD;
  &#xD;
            -  Subjects with partial layer skin transplantation&#xD;
  &#xD;
            -  There is no evidence of infection in the skin transplant process, and exudate is no&#xD;
               longer present a person who does not arise&#xD;
  &#xD;
            -  Decide to participate in this clinical study arbitrarily and in the written informed&#xD;
               consent a person&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  showing signs of infection requiring antibiotic administration throughout the body or&#xD;
               skin transplantation Case&#xD;
  &#xD;
            -  In situations where the requirements of a clinical study cannot be complied with&#xD;
  &#xD;
            -  When the researcher's judgment determines that the participation of the study is&#xD;
               inappropriate (e.g. Kelloid personality)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jihye Lee, Master</last_name>
      <role>Study Director</role>
      <affiliation>CGBio Inc.</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ajou University Hospital</name>
        <address>
          <city>Gyeonggi-do</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>CGBio Inc.</investigator_affiliation>
      <investigator_full_name>Eun-ji Kim</investigator_full_name>
      <investigator_title>Clinical Trial Manager</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05994781
  org study id: G2205
  nct id: NCT05994781
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical study is conducted prospectively for 3 months after medical device treatment.
  
        It is a comparative clinical study of the leading control group.
  Subjects need tissue transplantation to repair skin defects, so partial layer skin
        transplantation is performed. After proceeding, the patient is no longer subject to
        exudation. Subjects (and/or legal representatives) have agreed in writing to participate in
        the clinical study Perform a post-screening test.
  
        Evaluating the screening test results, meeting the selection criteria, and meeting the
        exclusion criteria those who do not are registered for clinical research.
  
        In the case of the study group among the subjects of the clinical study, whether partial
        layer skin transplantation was performed or not, Apply an appropriate amount of EasyDew MD
        Regen Cream twice a day (morning and evening) and can be absorbed well.
  
        The control group is a non-treatment group, and for 3 months after the procedure. General
        moisturizers that have been used or will be used are available. The control group's
        Moisturizer is recommended twice a day (morning and evening) on whether skin grafts are
        collected or not Apply and allow good absorption. After applying medical devices and
        moisturizers for clinical research, the progress will be observed for 3 months, Subjects are
        a screening visit (Visit1), the day of medical device application (Visit2), and after medical
        device application.
  
        Visit the research institution regularly for one month (Visit3) and three months after
        application (Visit4) for validity and it will be evaluated for safety.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: TEWL score
  time frame: Before, after one month after application, 3 month after application
  description: Transepidermal water loss score/ No range of upper and lower score, the lower is best
  measure: Investigator Global Assessment scale
  time frame: Before, after one month after application, 3 month after application
  description: Assess the patient's overall condition /lowest 0 score ( best score) to highest 30 score( worst score)
  measure: Dermatology Life Quality Index
  time frame: Before, after one month after application, 3 month after application
  description: Assess patient quality of life / lowest 0 score ( best score) to highest 4 score( worst score)
  measure: itching scale
  time frame: Before, after one month after application, 3 month after application
  description: Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst score)
  measure: VSS
  time frame: Before, after one month after application, 3 month after application
  description: Vancouver Scar Scale/ No range of upper and lower score, the lower is best
  arm group label: No treatment
  arm group type: No Intervention
  description: The control group is a non-treatment group, and for 3 months after the procedure, general moisturizers that have been used or will be used are available.
  arm group label: Treatment
  arm group type: Experimental
  description: In the case of the study group among the subjects of the clinical study, The experimental group apply an appropriate amount of EasyDew MD Regen Cream twice a day (morning and evening) and can be absorbed well.
  intervention type: Device
  intervention name: EasyDew MD regen cram
  description: No intervention
  arm group label: Treatment
  other name: No treatment
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jihye Lee, Master
  role: Study Director
  affiliation: CGBio Inc.
  facility: 
  country: Korea, Republic of
  responsible party type: Sponsor-Investigator
  investigator affiliation: CGBio Inc.
  investigator full name: Eun-ji Kim
  investigator title: Clinical Trial Manager
  sharing ipd: No