<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/NCT03289169</url>
  </required_header>
  <id_info>
    <org_study_id>MT01-KR16GBL401</org_study_id>
    <nct_id>NCT03289169</nct_id>
  </id_info>
  <brief_title>Long-term Safety and Efficacy of MEDITOXIN® in Treatment Glabellar Lines</brief_title>
  <official_title>A Single-Arm Trial, Open-label, Repeated, Long-term, Multi-center, A Phase IV Clinical Trial to Evaluate the Long-term Efficacy and Safety of Repeat Treatment With MEDITOXIN® in Treatment of Glabella Line</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medy-Tox</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medy-Tox</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 study evaluates the long-term safety of repeated administrations of Meditoxin® in the&#xD;
      treatment of moderate to severe glabellar lines.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 30, 2016</start_date>
  <completion_date type="Actual">May 29, 2019</completion_date>
  <primary_completion_date type="Actual">May 29, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment</measure>
    <time_frame>4 weeks after final injection</time_frame>
    <description>improvement are defined as subjects with glabellar line severity of none (0) or mild (1).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment</measure>
    <time_frame>4 weeks after each injection</time_frame>
    <description>Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment at 4 weeks after each injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment</measure>
    <time_frame>4 weeks after each injection</time_frame>
    <description>Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment at 4 weeks after each injection</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Glabellar Frown Lines</condition>
  <arm_group>
    <arm_group_label>MEDITOXIN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Meditoxin(Botulinum toxin type A)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDITOXIN®</intervention_name>
    <description>20U of Meditoxin® is injected to two places on the corrugators muscle for each eye and one place on the procerus muscle, total of 5 sites.</description>
    <arm_group_label>MEDITOXIN</arm_group_label>
    <other_name>Neuronox®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged between 20 and 65&#xD;
&#xD;
          -  Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of&#xD;
             glabella lines at maximum frown&#xD;
&#xD;
          -  Patients who can comply with the study procedures and visit schedule&#xD;
&#xD;
          -  Patients who voluntarily sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with medical conditions who may be at greater risk due to the administration&#xD;
             of the investigational drugs (e.g.. diseases that may affect the neuromuscular action&#xD;
             including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and&#xD;
             motor neuropathy)&#xD;
&#xD;
          -  Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis&#xD;
&#xD;
          -  Patients who have received other procedures which may affect glabellar and forehead&#xD;
             lines within 6 months&#xD;
&#xD;
          -  Patients who have received other procedures which may affect glabellar and forehead&#xD;
             lines within 6 months&#xD;
&#xD;
          -  Patients who were injected with botulinum toxin within the past 3 months&#xD;
&#xD;
          -  Patients with allergy or hypersensitivity to the investigational drugs or their&#xD;
             components&#xD;
&#xD;
          -  Patients who have bleeding tendency or taking anti-coagulant&#xD;
&#xD;
          -  Female subjects who are pregnant or lactating. Female subjects of childbearing age who&#xD;
             have a plan to get pregnant during the study period, or do not use available&#xD;
             contraceptive methods (Women of childbearing age should have negative urine pregnancy&#xD;
             test results at baseline visit (0 week) prior to the first injection.)&#xD;
&#xD;
          -  Patients with skin disorders or infection at the injection site&#xD;
&#xD;
          -  Patients who are participating in other clinical trials or have participated in other&#xD;
             clinical trials 30 days before screening&#xD;
&#xD;
          -  Patients who are unable to communicate or follow the instructions&#xD;
&#xD;
          -  Patients who are not eligible for this study based on the judgment of an investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St. Paul Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>130-709</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>August 25, 2020</last_update_submitted>
  <last_update_submitted_qc>August 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03289169
org study id: MT01-KR16GBL401
nct id: NCT03289169
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the long-term safety of repeated administrations of Meditoxin® in the
      treatment of moderate to severe glabellar lines.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment
time frame: 4 weeks after final injection
description: improvement are defined as subjects with glabellar line severity of none (0) or mild (1).
measure: Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment
time frame: 4 weeks after each injection
description: Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment at 4 weeks after each injection
measure: Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment
time frame: 4 weeks after each injection
description: Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment at 4 weeks after each injection
arm group label: MEDITOXIN
arm group type: Experimental
description: Meditoxin(Botulinum toxin type A)
intervention type: Drug
intervention name: MEDITOXIN®
description: 20U of Meditoxin® is injected to two places on the corrugators muscle for each eye and one place on the procerus muscle, total of 5 sites.
arm group label: MEDITOXIN
other name: Neuronox®
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Botulinum Toxins, Type A