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/NCT05982509</url>
    </required_header>
    <id_info>
      <org_study_id>G2204</org_study_id>
      <nct_id>NCT05982509</nct_id>
    </id_info>
    <brief_title>Clinical Trial to Assess the Efficacy and Safety of EASYDEW MD REGEN Cream Containing Neopop-S.</brief_title>
    <official_title>Clinical Trial to Assess the Efficacy and Safety of Neopop-S Containing EASYDEW</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>
        The purpose of this clinical study is to evaluate the effect on skin regeneration after&#xD;
        applying EasyDew MD Regen Cream containing Neopep-S, a regeneration factor, to patients who&#xD;
        have undergone picosure picosure laser skin treatment as needed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This clinical study is a researcher-led randomized control group comparative clinical study&#xD;
        that is conducted prospectively for one month after applying medical devices for clinical&#xD;
        research.&#xD;
  &#xD;
        The subjects are those who have undergone a picosure laser procedure for therapeutic purposes&#xD;
        on the skin tissue of the face or body, and a screening test is conducted after the subject&#xD;
        (and/or legal representative) agrees in writing to participate in the clinical study.&#xD;
  &#xD;
        The screening test results are evaluated, and subjects who meet the selection criteria and do&#xD;
        not meet the exclusion criteria are registered in clinical research.&#xD;
  &#xD;
        Participating subjects are randomly assigned to the control group and the study group using a&#xD;
        random number table at a 5:5 ratio.&#xD;
  &#xD;
          -  Control group: 10 people without treatment&#xD;
  &#xD;
          -  Study Group: 10 People Applying EasyDu Regen MD Cream Clinical study subjects are&#xD;
             randomly assigned to control and study groups. In the case of the study group, the Easy&#xD;
             Dew Regen MD cream provided through prescription is applied twice a day (morning and&#xD;
             evening) to the skin of the area where the picosure laser treatment has been performed&#xD;
             and absorbed well. The control group is the non-chalant group. However, general&#xD;
             moisturizers that were used at home rather than medical devices for one month after the&#xD;
             procedure can be used, and they are applied twice a day (morning and evening) to the&#xD;
             skin of the area where the laser treatment has been performed and absorbed well.&#xD;
  &#xD;
        One month of clinical research medical device application will be observed, and subjects will&#xD;
        regularly visit the research institution to evaluate its validity and safety during screening&#xD;
        visits (Visit1), treatment (Visit2), 2 weeks after treatment (Visit3), and 1 month after&#xD;
        treatment (Visit3) You will receive it.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 11, 2022</start_date>
    <completion_date type="Actual">July 27, 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 Transcutaneous water loss (TEWL) measured</measure>
      <time_frame>Before, immediately after treatment, and one month after application</time_frame>
      <description>Before, immediately after treatment, and one month after application of the medical device Transcutaneous water loss (TEWL) measured</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">20</enrollment>
    <condition>Laser-Induced Scar</condition>
    <arm_group>
      <arm_group_label>No intervention</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Control group: 10 people without treatment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Study Group: 10 People Applying EasyDew Regen MD Cream</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>EasyDew Regen MD Cream</intervention_name>
      <description>For the study group, I received the prescription Easy Dew Regen MD Cream from Picosure Laser Apply an appropriate amount twice a day (morning and evening) to the skin of the area so that it can be absorbed well do. The control group is the non-chalant group. However, for one month after the procedure, it is not a medical device The normal moisturizer you use at home is available, and the area where you have undergone laser treatment Apply it twice a day (morning and evening) to the skin so that it can be absorbed well.</description>
      <arm_group_label>Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Those aged 19 to 65 who have undergone picosure laser treatment on facial and body&#xD;
               skin tissues&#xD;
  &#xD;
            -  Decided to participate in this clinical study and signed a written informed consent&#xD;
               the subject&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects with uncontrolled diabetes&#xD;
  &#xD;
            -  Subjects with uncontrolled hypertension and cardiovascular disease&#xD;
  &#xD;
            -  Subjects with hemorrhagic diseases such as hemophilia&#xD;
  &#xD;
            -  Immunosuppressants, corticosteroids, cytotoxic agents, and anticoagulants can affect&#xD;
               the results Subjects who are or are scheduled to receive medication for an extended&#xD;
               period of time&#xD;
  &#xD;
            -  Acute or chronic skin disease causes stage progression or active bacteria in the&#xD;
               application area Who has a virus infection&#xD;
  &#xD;
            -  When the researcher's judgment determines that participation in the study is&#xD;
               inappropriate (e.g. keloid constitution)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jihye Lee</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>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 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/NCT05982509
  org study id: G2204
  nct id: NCT05982509
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this clinical study is to evaluate the effect on skin regeneration after
        applying EasyDew MD Regen Cream containing Neopep-S, a regeneration factor, to patients who
        have undergone picosure picosure laser skin treatment as needed.
  This clinical study is a researcher-led randomized control group comparative clinical study
        that is conducted prospectively for one month after applying medical devices for clinical
        research.
  
        The subjects are those who have undergone a picosure laser procedure for therapeutic purposes
        on the skin tissue of the face or body, and a screening test is conducted after the subject
        (and/or legal representative) agrees in writing to participate in the clinical study.
  
        The screening test results are evaluated, and subjects who meet the selection criteria and do
        not meet the exclusion criteria are registered in clinical research.
  
        Participating subjects are randomly assigned to the control group and the study group using a
        random number table at a 5:5 ratio.
  
          -  Control group: 10 people without treatment
  
          -  Study Group: 10 People Applying EasyDu Regen MD Cream Clinical study subjects are
             randomly assigned to control and study groups. In the case of the study group, the Easy
             Dew Regen MD cream provided through prescription is applied twice a day (morning and
             evening) to the skin of the area where the picosure laser treatment has been performed
             and absorbed well. The control group is the non-chalant group. However, general
             moisturizers that were used at home rather than medical devices for one month after the
             procedure can be used, and they are applied twice a day (morning and evening) to the
             skin of the area where the laser treatment has been performed and absorbed well.
  
        One month of clinical research medical device application will be observed, and subjects will
        regularly visit the research institution to evaluate its validity and safety during screening
        visits (Visit1), treatment (Visit2), 2 weeks after treatment (Visit3), and 1 month after
        treatment (Visit3) You will receive it.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Transepidermal water loss Transcutaneous water loss (TEWL) measured
  time frame: Before, immediately after treatment, and one month after application
  description: Before, immediately after treatment, and one month after application of the medical device Transcutaneous water loss (TEWL) measured
  arm group label: No intervention
  arm group type: No Intervention
  description: Control group: 10 people without treatment
  arm group label: Treatment
  arm group type: Experimental
  description: Study Group: 10 People Applying EasyDew Regen MD Cream
  intervention type: Device
  intervention name: EasyDew Regen MD Cream
  description: For the study group, I received the prescription Easy Dew Regen MD Cream from Picosure Laser Apply an appropriate amount twice a day (morning and evening) to the skin of the area so that it can be absorbed well do. The control group is the non-chalant group. However, for one month after the procedure, it is not a medical device The normal moisturizer you use at home is available, and the area where you have undergone laser treatment Apply it twice a day (morning and evening) to the skin so that it can be absorbed well.
  arm group label: Treatment
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jihye Lee
  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