<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/NCT04443244</url>
  </required_header>
  <id_info>
    <org_study_id>HG-BOTBMH-PII-01</org_study_id>
    <nct_id>NCT04443244</nct_id>
  </id_info>
  <brief_title>Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hugel</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hugel</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 is A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Optimal&#xD;
      Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign&#xD;
      Masseteric Hypertrophy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding&#xD;
      Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric&#xD;
      Hypertrophy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2020</start_date>
  <completion_date type="Actual">July 16, 2021</completion_date>
  <primary_completion_date type="Actual">November 18, 2020</primary_completion_date>
  <phase>Phase 2</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of change from baseline in masseter muscle thickness during maximum clenching</measure>
    <time_frame>Baseline to week 12</time_frame>
    <description>Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amount of change from baseline in masseter muscle thickness during maximum clenching</measure>
    <time_frame>Baseline to week 4, 8, 16</time_frame>
    <description>Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of change from baseline in masseter muscle thickness during maximum clenching</measure>
    <time_frame>Baseline to week 4, 8, 12, 16</time_frame>
    <description>Rate of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of change from baseline in masseter muscle thickness during resting</measure>
    <time_frame>Baseline to week 4, 8, 12, 16</time_frame>
    <description>Amount of change from baseline in masseter muscle thickness during resting by Ultrasonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of change from baseline in masseter muscle thickness during resting</measure>
    <time_frame>Baseline to week 4, 8, 12, 16</time_frame>
    <description>Rate of change from baseline in masseter muscle thickness during resting by Ultrasonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount and rate of change from baseline in lower face volume during maximum clenching</measure>
    <time_frame>Baseline to week 4, 8, 12, 16</time_frame>
    <description>Amount and rate of change from baseline in lower face volume during maximum clenching by 3D imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall improvement of Investigator</measure>
    <time_frame>Baseline to week 4, 8, 12, 16</time_frame>
    <description>Overall improvement of Investigator by assessment scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall satisfaction of subject</measure>
    <time_frame>Baseline to week 4, 8, 12, 16</time_frame>
    <description>Subject satisfaction assessment using a scale ranging from Extremely dissatisfied to Extremely satisfied by questionnaire</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Benign Masseteric Hypertrophy</condition>
  <arm_group>
    <arm_group_label>Botulinum Toxin Type A(Botulax®) 24Units</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Botulinum Toxin Type A (Botulax®) 24Units total dose administered intramuscularly to the bilateral masseter muscles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Botulinum Toxin Type A(Botulax®) 48Units</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Botulinum Toxin Type A (Botulax®) 48Units total dose administered intramuscularly to the bilateral masseter muscles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Botulinum Toxin Type A(Botulax®) 72Units</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Botulinum Toxin Type A (Botulax®) 72Units total dose administered intramuscularly to the bilateral masseter muscles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Botulinum Toxin Type A(Botulax®) 96Units</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Botulinum Toxin Type A (Botulax®) 96Units total dose administered intramuscularly to the bilateral masseter muscles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo(Normal Saline)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo(Normal saline) administered intramuscularly to the bilateral masseter muscles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum Toxin Type A Injection (Botulax®) 24Units</intervention_name>
    <description>Experimental: Botulax® 24Units</description>
    <arm_group_label>Botulinum Toxin Type A(Botulax®) 24Units</arm_group_label>
    <other_name>Botulax®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum Toxin Type A Injection (Botulax®) 48Units</intervention_name>
    <description>Experimental: Botulax® 48Units</description>
    <arm_group_label>Botulinum Toxin Type A(Botulax®) 48Units</arm_group_label>
    <other_name>Botulax®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum Toxin Type A Injection (Botulax®) 72Units</intervention_name>
    <description>Experimental: Botulax® 72Units</description>
    <arm_group_label>Botulinum Toxin Type A(Botulax®) 72Units</arm_group_label>
    <other_name>Botulax®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum Toxin Type A Injection (Botulax®) 96Units</intervention_name>
    <description>Experimental: Botulax® 96Units</description>
    <arm_group_label>Botulinum Toxin Type A(Botulax®) 96Units</arm_group_label>
    <other_name>Botulax®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>Placebo Comparator: Normal Saline</description>
    <arm_group_label>Placebo(Normal Saline)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and Female adults aged 19 or older.&#xD;
&#xD;
          2. Sighting, facilitation measurement are judged by the investigator to be the ratio of&#xD;
             Benign Masseteric Hypertrophy.&#xD;
&#xD;
          3. Subject who understand and willing to perform with the procedures and visiting&#xD;
             schedules of clinical trial.&#xD;
&#xD;
          4. Subject who voluntarily agree to participate in this clinical trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject who is clinically significant facial asymmetry in visual measurement by the&#xD;
             investigator.&#xD;
&#xD;
          2. Fertile women and men who have plans to conceive during pregnancy, breastfeeding and&#xD;
             clinical trials or who do not agree to appropriate contraception.&#xD;
&#xD;
          3. Subject who is deemed unable to participate in a clinical trial under the judgement of&#xD;
             a 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>
  <location>
    <facility>
      <name>Hugel</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>November 15, 2021</last_update_submitted>
  <last_update_submitted_qc>November 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>


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/NCT04443244
org study id: HG-BOTBMH-PII-01
nct id: NCT04443244
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Optimal
      Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign
      Masseteric Hypertrophy
A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding
      Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric
      Hypertrophy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Amount of change from baseline in masseter muscle thickness during maximum clenching
time frame: Baseline to week 12
description: Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography
measure: Amount of change from baseline in masseter muscle thickness during maximum clenching
time frame: Baseline to week 4, 8, 16
description: Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography
measure: Rate of change from baseline in masseter muscle thickness during maximum clenching
time frame: Baseline to week 4, 8, 12, 16
description: Rate of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography
measure: Amount of change from baseline in masseter muscle thickness during resting
time frame: Baseline to week 4, 8, 12, 16
description: Amount of change from baseline in masseter muscle thickness during resting by Ultrasonography
measure: Rate of change from baseline in masseter muscle thickness during resting
time frame: Baseline to week 4, 8, 12, 16
description: Rate of change from baseline in masseter muscle thickness during resting by Ultrasonography
measure: Amount and rate of change from baseline in lower face volume during maximum clenching
time frame: Baseline to week 4, 8, 12, 16
description: Amount and rate of change from baseline in lower face volume during maximum clenching by 3D imaging
measure: Overall improvement of Investigator
time frame: Baseline to week 4, 8, 12, 16
description: Overall improvement of Investigator by assessment scale
measure: Overall satisfaction of subject
time frame: Baseline to week 4, 8, 12, 16
description: Subject satisfaction assessment using a scale ranging from Extremely dissatisfied to Extremely satisfied by questionnaire
arm group label: Botulinum Toxin Type A(Botulax®) 24Units
arm group type: Experimental
description: Botulinum Toxin Type A (Botulax®) 24Units total dose administered intramuscularly to the bilateral masseter muscles.
arm group label: Botulinum Toxin Type A(Botulax®) 48Units
arm group type: Experimental
description: Botulinum Toxin Type A (Botulax®) 48Units total dose administered intramuscularly to the bilateral masseter muscles.
arm group label: Botulinum Toxin Type A(Botulax®) 72Units
arm group type: Experimental
description: Botulinum Toxin Type A (Botulax®) 72Units total dose administered intramuscularly to the bilateral masseter muscles.
arm group label: Botulinum Toxin Type A(Botulax®) 96Units
arm group type: Experimental
description: Botulinum Toxin Type A (Botulax®) 96Units total dose administered intramuscularly to the bilateral masseter muscles.
arm group label: Placebo(Normal Saline)
arm group type: Placebo Comparator
description: Placebo(Normal saline) administered intramuscularly to the bilateral masseter muscles.
intervention type: Drug
intervention name: Botulinum Toxin Type A Injection (Botulax®) 24Units
description: Experimental: Botulax® 24Units
arm group label: Botulinum Toxin Type A(Botulax®) 24Units
other name: Botulax®
intervention type: Drug
intervention name: Botulinum Toxin Type A Injection (Botulax®) 48Units
description: Experimental: Botulax® 48Units
arm group label: Botulinum Toxin Type A(Botulax®) 48Units
other name: Botulax®
intervention type: Drug
intervention name: Botulinum Toxin Type A Injection (Botulax®) 72Units
description: Experimental: Botulax® 72Units
arm group label: Botulinum Toxin Type A(Botulax®) 72Units
other name: Botulax®
intervention type: Drug
intervention name: Botulinum Toxin Type A Injection (Botulax®) 96Units
description: Experimental: Botulax® 96Units
arm group label: Botulinum Toxin Type A(Botulax®) 96Units
other name: Botulax®
intervention type: Other
intervention name: Normal Saline
description: Placebo Comparator: Normal Saline
arm group label: Placebo(Normal Saline)
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertrophy
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA