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/NCT06025058</url>
    </required_header>
    <id_info>
      <org_study_id>G2207</org_study_id>
      <nct_id>NCT06025058</nct_id>
    </id_info>
    <brief_title>Neopep-S-based EasyDew MD Regen Cream for Radiotherapy Subject After Breast Tumor Resection</brief_title>
    <official_title>Researcher-led Clinical Study to Evaluate the Effectiveness and Safety of the Application of Neopep-S-based Easy Dew MD Regen Cream in Patients Under Radiotherapy After Breast Tumor Resection</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;
        It is a comparative clinical study of the leading control group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Subject is a patient who has a tumor removed from the breast and is receiving radiotherapy at&#xD;
        the lesion.&#xD;
  &#xD;
        Subjects (and/or legal representatives) have agreed in writing to participate in the clinical&#xD;
        study.&#xD;
  &#xD;
        Perform a post-screening test. Evaluating the screening test results, meeting the selection&#xD;
        criteria, and meeting the exclusion criteria.&#xD;
  &#xD;
        Those who do not are registered for clinical research.&#xD;
  &#xD;
          -  Control group: Physiogel Skin Stability Intensive Cream MD (10 people)&#xD;
  &#xD;
          -  Study Group: EasyDew MD Regen Cream (20 people) The subjects of the clinical study are&#xD;
             randomly assigned in a 2:1 ratio between the study group and the control group.&#xD;
  &#xD;
        In this case, apply the control medical device twice a day (morning and evening) to the&#xD;
        radiation treatment area.&#xD;
  &#xD;
        Apply it. In the case of the research group, easy dew MD Regen Cream was applied to the&#xD;
        radiotherapy site.&#xD;
  &#xD;
        Apply an appropriate amount twice a day (in the evening) to ensure good absorption.&#xD;
  &#xD;
        The progress for three months after the application of medical devices for clinical research&#xD;
        will be observed, and the subjects will be screening visit (Visit1), medical device&#xD;
        application day (Visit2), medical device application, and medical device application.&#xD;
  &#xD;
        Visit the research institution regularly for one month (Visit3) and three months after&#xD;
        application (Visit4) for validity and to 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">July 28, 2023</completion_date>
    <primary_completion_date type="Actual">July 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>Transepidermal water loss</measure>
      <time_frame>before and one month, 3month after medical device application with GP SKin(machine/measuring the degree of moisture skin water loss)</time_frame>
      <description>Percutaneous moisture loss measured</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Itching score</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</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>
    <secondary_outcome>
      <measure>BREAST-Q Survey Assessment</measure>
      <time_frame>Before, after one month after application, 3 month after application</time_frame>
      <description>Evaluate the BREAST-Q Survey Assessment/ lowest 1 score (worst) to highest 10 score( best score)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Skin Lesion</condition>
    <arm_group>
      <arm_group_label>Easy Dew MD Regen Cream</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>
    <arm_group>
      <arm_group_label>Physiogel Stability Intensive Cream MD</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The subject applies the provided medical device twice a day (morning and evening) to areas with symptoms of dry skin so that it can be absorbed well.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Easy Dew MD Regen Cream</intervention_name>
      <description>The subject applies the provided medical device twice a day (morning and evening) to areas with symptoms of dry skin so that it can be absorbed well.</description>
      <arm_group_label>Easy Dew MD Regen Cream</arm_group_label>
      <arm_group_label>Physiogel Stability Intensive Cream MD</arm_group_label>
      <other_name>Physiogel Stability Intensive Cream MD</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adults over the age of 19&#xD;
  &#xD;
            -  The tumor in the breast area is resected and radiotherapy is planned, performed, or&#xD;
               Subjects with a history of irradiation&#xD;
  &#xD;
            -  Decide to participate in this clinical study arbitrarily and in the written informed&#xD;
               consent a person to whom&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  When participating in a clinical study, the findings of radiation dermatitis in the&#xD;
               area are shown&#xD;
  &#xD;
            -  A person who shows signs of acute or chronic dermatological diseases&#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>No</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>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <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/NCT06025058
  org study id: G2207
  nct id: NCT06025058
  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.
  Subject is a patient who has a tumor removed from the breast and is receiving radiotherapy at
        the lesion.
  
        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.
  
          -  Control group: Physiogel Skin Stability Intensive Cream MD (10 people)
  
          -  Study Group: EasyDew MD Regen Cream (20 people) The subjects of the clinical study are
             randomly assigned in a 2:1 ratio between the study group and the control group.
  
        In this case, apply the control medical device twice a day (morning and evening) to the
        radiation treatment area.
  
        Apply it. In the case of the research group, easy dew MD Regen Cream was applied to the
        radiotherapy site.
  
        Apply an appropriate amount twice a day (in the evening) to ensure good absorption.
  
        The progress for three months after the application of medical devices for clinical research
        will be observed, and the subjects will be screening visit (Visit1), medical device
        application day (Visit2), medical device application, and medical device application.
  
        Visit the research institution regularly for one month (Visit3) and three months after
        application (Visit4) for validity and to be evaluated for safety.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Transepidermal water loss
  time frame: before and one month, 3month after medical device application with GP SKin(machine/measuring the degree of moisture skin water loss)
  description: Percutaneous moisture loss measured
  measure: Itching score
  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
  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
  measure: BREAST-Q Survey Assessment
  time frame: Before, after one month after application, 3 month after application
  description: Evaluate the BREAST-Q Survey Assessment/ lowest 1 score (worst) to highest 10 score( best score)
  arm group label: Easy Dew MD Regen Cream
  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.
  arm group label: Physiogel Stability Intensive Cream MD
  arm group type: Active Comparator
  description: The subject applies the provided medical device twice a day (morning and evening) to areas with symptoms of dry skin so that it can be absorbed well.
  intervention type: Device
  intervention name: Easy Dew MD Regen Cream
  description: The subject applies the provided medical device twice a day (morning and evening) to areas with symptoms of dry skin so that it can be absorbed well.
  arm group label: Easy Dew MD Regen Cream
  arm group label: Physiogel Stability Intensive Cream MD
  other name: Physiogel Stability Intensive Cream MD
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  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
  mesh term: Breast Neoplasms
  sharing ipd: No