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/NCT06021418</url>
    </required_header>
    <id_info>
      <org_study_id>DKB-119-MD-2</org_study_id>
      <nct_id>NCT06021418</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of DKB-119 in Patients in Crow's Feet</brief_title>
    <official_title>A Single Center, Randomized, Subject and Evaluator Blinded, Split-face, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of DKB-119 in Crow's Feet</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dongkook Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dongkook Pharmaceutical Co., Ltd.</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>
        To prove the non-inferiority of DKB-119 by evaluating the injecting efficacy and safety&#xD;
        DKB-119 and control for patients in crow's feet&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A single center, randomized, subject and evaluator blinded, split-face, pivotal clinical&#xD;
        trial&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">November 2, 2020</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 8, 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>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Blind: Participant, Outcomes Assessor&#xD;
  Un-blind: Investigator(Care Provider)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Crow's feet</measure>
      <time_frame>18 weeks</time_frame>
      <description>Difference in improvement rate (percentage)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Crow's feet</measure>
      <time_frame>8, 10 weeks</time_frame>
      <description>Difference in improvement rate (percentage)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LCL(Lateral Canthal Line) Severity</measure>
      <time_frame>8, 10, 18 weeks</time_frame>
      <description>Difference in improvement rate (percentage)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GAIS(Global Aesthetic Improvement Scale)</measure>
      <time_frame>8, 10, 18 weeks</time_frame>
      <description>GAIS 5 point scale (minimum -1 to maximum 3 points, The higher the score, the better the value)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">100</enrollment>
    <condition>Crow's Feet</condition>
    <arm_group>
      <arm_group_label>DKB-119</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Injecting to one side crow's feet</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Injecting to one side crow's feet</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>DKB-119</intervention_name>
      <description>Experimental and Acitve Comparator are applied 4 times to each of crow's feet on both sides of the subject.</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>DKB-119</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Those who are over 19 under 70 ages.&#xD;
  &#xD;
            -  Those who score 2 or more in the LCL severity evaluation.&#xD;
  &#xD;
            -  Those who have visually symmetrical crow's feet on both sides.&#xD;
  &#xD;
            -  Etc.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy and lactating women.&#xD;
  &#xD;
            -  Etc.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Chungang-University Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>April 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </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/NCT06021418
  org study id: DKB-119-MD-2
  nct id: NCT06021418
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To prove the non-inferiority of DKB-119 by evaluating the injecting efficacy and safety
        DKB-119 and control for patients in crow's feet
  A single center, randomized, subject and evaluator blinded, split-face, pivotal clinical
        trial
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Blind: Participant, Outcomes Assessor
  Un-blind: Investigator(Care Provider)
  measure: Crow's feet
  time frame: 18 weeks
  description: Difference in improvement rate (percentage)
  measure: Crow's feet
  time frame: 8, 10 weeks
  description: Difference in improvement rate (percentage)
  measure: LCL(Lateral Canthal Line) Severity
  time frame: 8, 10, 18 weeks
  description: Difference in improvement rate (percentage)
  measure: GAIS(Global Aesthetic Improvement Scale)
  time frame: 8, 10, 18 weeks
  description: GAIS 5 point scale (minimum -1 to maximum 3 points, The higher the score, the better the value)
  arm group label: DKB-119
  arm group type: Experimental
  description: Injecting to one side crow's feet
  arm group label: Control
  arm group type: Active Comparator
  description: Injecting to one side crow's feet
  intervention type: Device
  intervention name: DKB-119
  description: Experimental and Acitve Comparator are applied 4 times to each of crow's feet on both sides of the subject.
  arm group label: Control
  arm group label: DKB-119
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  country: Korea, Republic of
  responsible party type: Sponsor
  sharing ipd: No