<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/NCT03785145</url>
  </required_header>
  <id_info>
    <org_study_id>MT10109L-002</org_study_id>
    <secondary_id>2014-005279-10</secondary_id>
    <nct_id>NCT03785145</nct_id>
  </id_info>
  <brief_title>MT10109L in the Treatment of Lateral Canthal Lines</brief_title>
  <official_title>A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Lateral Canthal Lines</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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and efficacy of MT10109L in the treatment of lateral canthal lines&#xD;
      (LCL) in participants with moderate to severe LCL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">January 25, 2021</completion_date>
  <primary_completion_date type="Actual">February 27, 2020</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>The proportion of participants with a ≥ 2-grade improvement from baseline on the Facial Wrinkle Scale with Photonumeric Guide (FWS) according to investigator and participant assessments of LCL severity at maximum smile at Day 30</measure>
    <time_frame>Day 30</time_frame>
    <description>The investigator and participant evaluate the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The duration of LCL treatment in participants who achieved a rating of ≥ 2 grade improvement from baseline in LCL severity at maximum smile at Day 30 according to investigator assessments using the FWS</measure>
    <time_frame>Day 1 (first treatment) to Day 180</time_frame>
    <description>The investigator evaluates the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of responders for investigator assessments of LCL severity at maximum smile using the FWS</measure>
    <time_frame>Day 30</time_frame>
    <description>The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants reporting mostly satisfied/very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) follow-up version Item 5 for LCL</measure>
    <time_frame>Day 60</time_frame>
    <description>The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of responders for investigator assessments of LCL severity at rest using the FWS</measure>
    <time_frame>Day 30</time_frame>
    <description>The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who experienced an adverse event</measure>
    <time_frame>From Consent (Screening Visit) up to Day 420</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in vital signs</measure>
    <time_frame>Baseline to Day 360</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in Electrocardiogram (ECG) parameters</measure>
    <time_frame>Baseline to Day 360</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with binding and neutralizing antibodies</measure>
    <time_frame>Day 360</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">235</enrollment>
  <condition>Lateral Canthal Lines</condition>
  <arm_group>
    <arm_group_label>MT10109L</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MT10109L will be injected into the LCL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo will be injected into the LCL: initial double-blind treatment on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MT10109L</intervention_name>
    <description>MT10109L will be injected into the LCL.</description>
    <arm_group_label>MT10109L</arm_group_label>
    <other_name>NivobotulinumtoxinA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be injected into the LCL.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        • Female participants must not be pregnant or planning to get pregnant and willing to&#xD;
        minimize the risk of inducing pregnancy for the duration of the clinical study and&#xD;
        follow-up period.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Known immunization or hypersensitivity to any botulinum toxin serotype.&#xD;
&#xD;
          -  Any medical condition that may put the participant at increased risk with exposure to&#xD;
             MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic&#xD;
             lateral sclerosis, or any other condition that might interfere with neuromuscular&#xD;
             function.&#xD;
&#xD;
          -  History of facial nerve palsy.&#xD;
&#xD;
          -  Any uncontrolled systemic disease.&#xD;
&#xD;
          -  Anticipated need for treatment with botulinum toxin of any serotype for any reason&#xD;
             during the study (other than study intervention).&#xD;
&#xD;
          -  Anticipated need for surgery or overnight hospitalization during the study.&#xD;
&#xD;
          -  Prior exposure to botulinum toxin of any serotype for any reason.&#xD;
&#xD;
          -  Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow&#xD;
             lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery).&#xD;
&#xD;
          -  Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg,&#xD;
             Gore-Tex®), and/or autologous fat transplantation.&#xD;
&#xD;
          -  Current enrollment in an investigational drug or device study or participation in such&#xD;
             a study within 30 days of entry into this study.&#xD;
&#xD;
          -  Females who are pregnant, nursing, or planning a pregnancy during the study.&#xD;
&#xD;
          -  Participants who plan for an extended absence away from the immediate area of the&#xD;
             study site that would preclude them from returning for all protocol-specified study&#xD;
             visits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>SangMi Park</last_name>
    <role>Study Director</role>
    <affiliation>Medytox Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Advanced Research Associates</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Research Foundation</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Research Institute LLC</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coleman Dermatologic Surgery Center</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Laser, Skin, &amp; Vein Institute</name>
      <address>
        <city>Hunt Valley</city>
        <state>Maryland</state>
        <zip>21030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laser Skin Surgery Center of New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bellaire Dermatology Associates</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SkinDC</name>
      <address>
        <city>Arlington</city>
        <state>Virginia</state>
        <zip>22209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Clinical Research, Inc.</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow scientific-practical centre of dermatovenerology and cosmetology</name>
      <address>
        <city>Moscow</city>
        <zip>127473</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budget Institution of Higher Education North-Western State Medical University named after I.I Mechnikov</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>194291</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Expert Aesthetics Ltd</name>
      <address>
        <city>Alderley Edge</city>
        <state>Cheshire</state>
        <zip>SK9 7ES</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waverley Medical Practice</name>
      <address>
        <city>Coatbridge</city>
        <state>North Lanarkshire</state>
        <zip>ML5 3AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizen Clinic</name>
      <address>
        <city>Sutton Coldfield</city>
        <state>West Midlands</state>
        <zip>B74 2UG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <disposition_first_submitted>February 10, 2021</disposition_first_submitted>
  <last_update_submitted>January 26, 2023</last_update_submitted>
  <last_update_submitted_qc>January 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 2, 2023</submitted>
    <returned>June 27, 2023</returned>
    <submitted>July 17, 2023</submitted>
    <returned>August 2, 2023</returned>
    <submitted>August 16, 2023</submitted>
    <returned>September 8, 2023</returned>
    <submitted>September 14, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03785145
org study id: MT10109L-002
secondary id: 2014-005279-10
nct id: NCT03785145
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To evaluate the safety and efficacy of MT10109L in the treatment of lateral canthal lines
      (LCL) in participants with moderate to severe LCL.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The proportion of participants with a ≥ 2-grade improvement from baseline on the Facial Wrinkle Scale with Photonumeric Guide (FWS) according to investigator and participant assessments of LCL severity at maximum smile at Day 30
time frame: Day 30
description: The investigator and participant evaluate the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe
measure: The duration of LCL treatment in participants who achieved a rating of ≥ 2 grade improvement from baseline in LCL severity at maximum smile at Day 30 according to investigator assessments using the FWS
time frame: Day 1 (first treatment) to Day 180
description: The investigator evaluates the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
measure: The proportion of responders for investigator assessments of LCL severity at maximum smile using the FWS
time frame: Day 30
description: The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.
measure: The proportion of participants reporting mostly satisfied/very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) follow-up version Item 5 for LCL
time frame: Day 60
description: The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.
measure: The proportion of responders for investigator assessments of LCL severity at rest using the FWS
time frame: Day 30
description: The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.
measure: Number of patients who experienced an adverse event
time frame: From Consent (Screening Visit) up to Day 420
measure: Mean change from baseline in vital signs
time frame: Baseline to Day 360
measure: Mean change from baseline in Electrocardiogram (ECG) parameters
time frame: Baseline to Day 360
measure: Number of participants with binding and neutralizing antibodies
time frame: Day 360
arm group label: MT10109L
arm group type: Experimental
description: MT10109L will be injected into the LCL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo will be injected into the LCL: initial double-blind treatment on Day 1.
intervention type: Drug
intervention name: MT10109L
description: MT10109L will be injected into the LCL.
arm group label: MT10109L
other name: NivobotulinumtoxinA
intervention type: Drug
intervention name: Placebo
description: Placebo will be injected into the LCL.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: SangMi Park
role: Study Director
affiliation: Medytox Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Russian Federation
country: United Kingdom
country: United States
responsible party type: Sponsor
sharing ipd: No
submitted: June 2, 2023
returned: June 27, 2023
submitted: July 17, 2023
returned: August 2, 2023
submitted: August 16, 2023
returned: September 8, 2023
submitted: September 14, 2023