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/NCT05982535</url>
    </required_header>
    <id_info>
      <org_study_id>G2206</org_study_id>
      <nct_id>NCT05982535</nct_id>
    </id_info>
    <brief_title>Neopep-S Ingredient Easy Dew MD Regen Cream</brief_title>
    <official_title>The Application of Neopep-S Ingredient Easy Dew MD Regen Cream in the Indication of Dry Skin A Prospective Researcher-led Clinical Study to Assess Efficacy and Safety</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 provide patients diagnosed with dry skin due to&#xD;
        various causes such as atopic dermatitis and Yangjin The effect on skin regeneration after&#xD;
        applying EasyDew MD Regen Cream containing Neopep-S, a regeneration factor, and It is&#xD;
        intended to assess safety.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The total study period for this clinical study is 12 months from the date of IRB approval,&#xD;
        led by researchers from a single institution It's a clinical study. The individual&#xD;
        participation period of the participant is one month.&#xD;
  &#xD;
        Subjects are those diagnosed with dry skin due to a variety of factors (and/or courts)&#xD;
        Agents) perform screening tests after agreeing in writing to participate in the clinical&#xD;
        study.&#xD;
  &#xD;
        Evaluating the screening test results, and subjects who meet the selection criteria and do&#xD;
        not meet the exclusion criteria, for clinical research It must be registered. Random&#xD;
        assignments of the study group and control group are conducted in a random number table at a&#xD;
        5:5 ratio.&#xD;
  &#xD;
          -  Control group: 10 people with dexian med cream&#xD;
  &#xD;
          -  Research Group: 10 people applying EasyDew MD Regen Cream Clinical study subjects are&#xD;
             randomly assigned to control and study groups. The control group is Dexian, a foreign&#xD;
             medical device product Med cream is applied, and in the case of the study group,&#xD;
             EasyDewMD Regen cream provided through prescription is applied. clinical practice&#xD;
             Subjects apply an appropriate amount twice a day (morning and evening) to skin areas&#xD;
             with dry skin symptoms and can be absorbed well Let's make it happen. After applying the&#xD;
             medical device for clinical research, the progress is observed for one month, and the&#xD;
             subject is subject to about one month of clinical research During the period, research&#xD;
             institutes will be regularly visited to evaluate their validity and safety on the day of&#xD;
             screening (Visit1), the day of medical device application (Visit2), 2 weeks after&#xD;
             medical device application (Visit3), and 1 month after application (Visit4).&#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</measure>
      <time_frame>before and one month after medical device application</time_frame>
      <description>Percutaneous moisture loss measured</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Investigator Global Assessment Scale</measure>
      <time_frame>before medical device application and one month after medical device 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 medical device application and one month after medical device 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 score</measure>
      <time_frame>before medical device application and one month after medical device application</time_frame>
      <description>Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst score)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">20</enrollment>
    <condition>Dry Skin</condition>
    <arm_group>
      <arm_group_label>Easy Dew MD Regen Cream</arm_group_label>
      <arm_group_type>Experimental</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>
    <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;
            1. Subjects diagnosed with xerotic skin among adults aged 19 to 80 years&#xD;
  &#xD;
            2. Subjects who have voluntarily decided to participate in this clinical study and signed&#xD;
               a written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects with uncontrolled diabetes&#xD;
  &#xD;
            2. Immunosuppressants, corticosteroids, cytotoxic drugs, anticoagulants, etc. are&#xD;
               included in the results You are on long-term or scheduled to receive medication that&#xD;
               may affect you a person who is subject to&#xD;
  &#xD;
            3. Acute or chronic skin disease; stage in progress or active in the area of application&#xD;
               Subject to bacterial or viral infection&#xD;
  &#xD;
            4. Where the researcher's judgment determines that participation in the study is&#xD;
               inappropriate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>80 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/NCT05982535
  org study id: G2206
  nct id: NCT05982535
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this clinical study is to provide patients diagnosed with dry skin due to
        various causes such as atopic dermatitis and Yangjin The effect on skin regeneration after
        applying EasyDew MD Regen Cream containing Neopep-S, a regeneration factor, and It is
        intended to assess safety.
  The total study period for this clinical study is 12 months from the date of IRB approval,
        led by researchers from a single institution It's a clinical study. The individual
        participation period of the participant is one month.
  
        Subjects are those diagnosed with dry skin due to a variety of factors (and/or courts)
        Agents) perform screening tests after agreeing in writing to participate in the clinical
        study.
  
        Evaluating the screening test results, and subjects who meet the selection criteria and do
        not meet the exclusion criteria, for clinical research It must be registered. Random
        assignments of the study group and control group are conducted in a random number table at a
        5:5 ratio.
  
          -  Control group: 10 people with dexian med cream
  
          -  Research Group: 10 people applying EasyDew MD Regen Cream Clinical study subjects are
             randomly assigned to control and study groups. The control group is Dexian, a foreign
             medical device product Med cream is applied, and in the case of the study group,
             EasyDewMD Regen cream provided through prescription is applied. clinical practice
             Subjects apply an appropriate amount twice a day (morning and evening) to skin areas
             with dry skin symptoms and can be absorbed well Let's make it happen. After applying the
             medical device for clinical research, the progress is observed for one month, and the
             subject is subject to about one month of clinical research During the period, research
             institutes will be regularly visited to evaluate their validity and safety on the day of
             screening (Visit1), the day of medical device application (Visit2), 2 weeks after
             medical device application (Visit3), and 1 month after application (Visit4).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Transepidermal water loss
  time frame: before and one month after medical device application
  description: Percutaneous moisture loss measured
  measure: Investigator Global Assessment Scale
  time frame: before medical device application and one month after medical device 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 medical device application and one month after medical device application
  description: Assess patient quality of life / lowest 0 score ( best score) to highest 4 score( worst score)
  measure: Itching score
  time frame: before medical device application and one month after medical device application
  description: Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst score)
  arm group label: Easy Dew MD Regen Cream
  arm group type: Experimental
  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: 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: 80 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