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/NCT05964257</url>
    </required_header>
    <id_info>
      <org_study_id>HU-014_P3_BMH</org_study_id>
      <nct_id>NCT05964257</nct_id>
    </id_info>
    <brief_title>To Evaluate the Efficacy and Safety of LIZTOX in Subjects With Benign Masseteric Hypertrophy</brief_title>
    <official_title>A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of LIZTOX in Subjects With Benign Masseteric Hypertrophy.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Huons Biopharma</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Huons Biopharma</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A double-blind, randomized, placebo-controlled, multi-center, phase III study to evaluate the&#xD;
        efficacy and safety of LIZTOX in subjects with benign massesric hypertrophy&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 25, 2023</start_date>
    <completion_date type="Anticipated">May 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2024</primary_completion_date>
    <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline in masseter muscle thickness</measure>
      <time_frame>12week</time_frame>
      <description>Change from baseline in masseter muscle thickness by Ultrasonography</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">168</enrollment>
    <condition>Benign Masseteric Hypertrophy</condition>
    <arm_group>
      <arm_group_label>HU-014</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Botulinum toxin type A</intervention_name>
      <description>Botulinum toxin type A(HU-014) will be administered intramuscularly to the bilateral masseter muscles on Visit 2.</description>
      <arm_group_label>HU-014</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>normal Saline</intervention_name>
      <description>Normal Saline will be administered intramuscularly to the bilateral masseter muscles on Visit 2.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female subject over 19 years of age and written informed consent is obtained.&#xD;
  &#xD;
            -  Subject who has bisymmetry of masseter at visual and palpable assessment.&#xD;
  &#xD;
            -  Subject who meets thickness of masseter muscle by ultrasonography.&#xD;
  &#xD;
            -  Subject who has a scale of benign masseter hypertrophy of 4 or more as determined by&#xD;
               investigator.&#xD;
  &#xD;
            -  Subject who fully understands this clinical trial and voluntarily writes ICF in the&#xD;
               clinical trial.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subject who had previously received botulinum toxin within 12 weeks prior to the study&#xD;
               entry.&#xD;
  &#xD;
            -  Subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment&#xD;
               etc.) in lower facial area within 48 weeks prior to the study entry.&#xD;
  &#xD;
            -  Subject who has a disease(e.g. Temporo mandibular joint disorder, etc.)&#xD;
  &#xD;
            -  Subject who were diagnosed Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic&#xD;
               lateral sclerosis, or any other condition that might influence with neuromuscular&#xD;
               function.&#xD;
  &#xD;
            -  Subject who had taken medication(e.g. muscle relaxant, polypeptide antibiotics,&#xD;
               aminoglycoside antibiotics, etc.) within 4 weeks prior to the study entry.&#xD;
  &#xD;
            -  Subject with known hypersensitivity to botulinum toxin.&#xD;
  &#xD;
            -  Subject who are pregnant or lactating or planing pregnancy or disagreed to avoid&#xD;
               pregnancy during study period.&#xD;
  &#xD;
            -  Subject who participate other clinical trials within 4 weeks prior to the study entry.&#xD;
  &#xD;
            -  Subject who are not eligible for this study at the discretion of the investigator.&#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_contact>
      <last_name>Ham kiltae</last_name>
      <phone>+82-02-854-4700</phone>
      <email>kiltae.ham@HUONS.COM</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chung-Ang University Hospital</name>
        <address>
          <city>Dongjak</city>
          <state>Seoul</state>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bum-joon Kim</last_name>
        <phone>+82-2-6299-1718</phone>
        <email>beomjoon74@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>BMH</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertrophy</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Botulinum Toxins</mesh_term>
      <mesh_term>Botulinum Toxins, Type A</mesh_term>
      <mesh_term>abobotulinumtoxinA</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05964257
  org study id: HU-014_P3_BMH
  nct id: NCT05964257
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  A double-blind, randomized, placebo-controlled, multi-center, phase III study to evaluate the
        efficacy and safety of LIZTOX in subjects with benign massesric hypertrophy
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change from baseline in masseter muscle thickness
  time frame: 12week
  description: Change from baseline in masseter muscle thickness by Ultrasonography
  arm group label: HU-014
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Botulinum toxin type A
  description: Botulinum toxin type A(HU-014) will be administered intramuscularly to the bilateral masseter muscles on Visit 2.
  arm group label: HU-014
  intervention type: Drug
  intervention name: normal Saline
  description: Normal Saline will be administered intramuscularly to the bilateral masseter muscles on Visit 2.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ham kiltae
  phone: +82-02-854-4700
  email: kiltae.ham@HUONS.COM
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Hypertrophy
  mesh term: Botulinum Toxins
  mesh term: Botulinum Toxins, Type A
  mesh term: abobotulinumtoxinA