<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/NCT03837561</url>
  </required_header>
  <id_info>
    <org_study_id>MT01-RU18GBL301</org_study_id>
    <nct_id>NCT03837561</nct_id>
  </id_info>
  <brief_title>The Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines</brief_title>
  <official_title>Phase Ⅲ, Randomized, Double-Blind, Active Controlled, Multi-Center, Clinical Trial to Evaluate the Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medy-Tox</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medy-Tox</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>
      To Confirm the non-inferiority of CUNOX® to BOTOX® in the glabellar line improvement of&#xD;
      moderate to severe glabellar lines.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Actual">June 3, 2019</completion_date>
  <primary_completion_date type="Actual">March 12, 2019</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>Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity</measure>
    <time_frame>at 4 weeks after the injection.</time_frame>
    <description>An investigator makes a live assessment of subject's glabellar lines at maximum frown on a 4-grade scale (0 (none), 1 (mild), 2 (moderate) and 3 (severe)) 4 weeks after the administration of the investigational drug or the comparator. 0 or 1 point is considered as &quot;improved&quot; and glabellar line improvement rate is calculated.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">136</enrollment>
  <condition>Glabellar Frown Lines</condition>
  <arm_group>
    <arm_group_label>Cunox</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cunox (botulinum toxin type A), 0.1 mL injected into each of 5 sites once.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Botox</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Botox (botulinum toxin type A), 0.1 mL injected into each of 5 sites once.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cunox</intervention_name>
    <description>Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.</description>
    <arm_group_label>Cunox</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botox</intervention_name>
    <description>Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.</description>
    <arm_group_label>Botox</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged between 18 and 65&#xD;
&#xD;
          -  Subjects attaining ≥ grade 2 (moderate) in the investigator's rating of the severity&#xD;
             of glabellar lines at maximum forced frown&#xD;
&#xD;
          -  Subjects who voluntarily sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with allergy or hypersensitivity to the investigational drugs or their&#xD;
             components&#xD;
&#xD;
          -  Subjects who are participating in other clinical trials or have participated in&#xD;
             clinical trials 30 days before screening&#xD;
&#xD;
          -  Subjects who are not eligible for this study at the discretion of the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical Center Capital-Health</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03837561
org study id: MT01-RU18GBL301
nct id: NCT03837561
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To Confirm the non-inferiority of CUNOX® to BOTOX® in the glabellar line improvement of
      moderate to severe glabellar lines.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity
time frame: at 4 weeks after the injection.
description: An investigator makes a live assessment of subject's glabellar lines at maximum frown on a 4-grade scale (0 (none), 1 (mild), 2 (moderate) and 3 (severe)) 4 weeks after the administration of the investigational drug or the comparator. 0 or 1 point is considered as "improved" and glabellar line improvement rate is calculated.
arm group label: Cunox
arm group type: Experimental
description: Cunox (botulinum toxin type A), 0.1 mL injected into each of 5 sites once.
arm group label: Botox
arm group type: Active Comparator
description: Botox (botulinum toxin type A), 0.1 mL injected into each of 5 sites once.
intervention type: Drug
intervention name: Cunox
description: Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.
arm group label: Cunox
intervention type: Drug
intervention name: Botox
description: Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.
arm group label: Botox
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Russian Federation
responsible party type: Sponsor