<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/NCT03806933</url>
  </required_header>
  <id_info>
    <org_study_id>M602011015</org_study_id>
    <secondary_id>2018-002743-28</secondary_id>
    <nct_id>NCT03806933</nct_id>
  </id_info>
  <brief_title>Study to Investigate the Safety and Duration of Effect of Different Botulinum Toxin A (NT 201) Dose Groups Following the Treatment of Glabellar Frown Lines</brief_title>
  <official_title>A Prospective, Randomized, Double-blind, Multicenter Study to Investigate the Safety and Duration of Effect of Different NT 201 Dose Groups Following the Treatment of Glabellar Frown Lines</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merz Pharmaceuticals GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merz Pharmaceuticals GmbH</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>
      The purpose of the study is to investigate the safety and duration of effect following&#xD;
      different doses of Botulinum Toxin A (NT 201) in the treatment of glabellar frown lines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective, randomized, double-blind, multi-Center clinical study consists of a two&#xD;
      stage experimental main period comparing different dose groups, followed by an optional&#xD;
      open-label extension (20 Units follow-up treatment).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Actual">October 8, 2020</completion_date>
  <primary_completion_date type="Actual">September 10, 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>Duration of effect as defined by time between treatment and relapse to baseline status</measure>
    <time_frame>From time of treatment to up to 360 days</time_frame>
    <description>Effect is defined as improvement at maximum frown as assessed by the investigator on the Facial Wrinkle Scale (FWS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of effect whereby effect is defined by a score of none (0) or mild (1) at maximum frown as assessed by the investigator according to FWS</measure>
    <time_frame>From time of treatment to up to 360 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of effect whereby effect is defined as 2-point improvement from baseline at maximum frown as assessed by the investigator according to FWS</measure>
    <time_frame>From time of treatment to up to 360 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects rated as none (0) or mild (1) at maximum frown by investigator's rating on FWS at Day 180</measure>
    <time_frame>Day 180</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects rated as none (0) or mild (1) at maximum frown by subject's rating on FWS at Day 180</measure>
    <time_frame>Day 180</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects rated as at least 1-point improvement compared to baseline at maximum frown by investigator's rating on FWS at Day 180</measure>
    <time_frame>Day 180</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects rated as at least 1-point improvement compared to baseline at maximum frown by subject's rating on FWS Subject at Day 180</measure>
    <time_frame>Day 180</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">241</enrollment>
  <condition>Moderate to Severe Glabellar Frown Lines</condition>
  <arm_group>
    <arm_group_label>NT 201 Dose group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stage 1 and 2. Intramuscular injection into the glabellar area.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NT 201 Dose group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stage 1. Intramuscular injection into the glabellar area.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NT 201 Dose group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stage 1. Intramuscular injection into the glabellar area.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NT 201 Dose group 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stage 2. Intramuscular injection into the glabellar area.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NT 201 Dose group 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open Label Extension Period. Intramuscular injection into the glabellar area.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NT 201</intervention_name>
    <description>Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).</description>
    <arm_group_label>NT 201 Dose group 1</arm_group_label>
    <arm_group_label>NT 201 Dose group 2</arm_group_label>
    <arm_group_label>NT 201 Dose group 3</arm_group_label>
    <arm_group_label>NT 201 Dose group 4</arm_group_label>
    <arm_group_label>NT 201 Dose group 5</arm_group_label>
    <other_name>IncobotulinumtoxinA</other_name>
    <other_name>Xeomin</other_name>
    <other_name>Botulinum toxin type A (150 kiloDalton), free from complexing proteins</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subject 18 years or over.&#xD;
&#xD;
          -  Moderate (score = 2) to severe (score =3) GFL at maximum frown as assessed by&#xD;
             investigator on the 4-point FWS.&#xD;
&#xD;
          -  Moderate (score = 2) to severe (score =3) GFL at maximum frown as assessed by subject&#xD;
             on the 4-point FWS.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment with Botulinum neurotoxin (BoNT) of any serotype in the facial area&#xD;
             within the last 12 months before injection.&#xD;
&#xD;
          -  Previous treatment with any facial cosmetic procedure (e.g., chemical peeling, photo&#xD;
             rejuvenation, mesotherapy, photodynamic therapy, laser treatment, tattooing of&#xD;
             eyebrows) in the glabellar area within the last 12 months before injection.&#xD;
&#xD;
          -  Previous treatment with any biodegradable filler in the glabellar area within the last&#xD;
             12 months before injection.&#xD;
&#xD;
          -  Inability to substantially reduce GFL by physically spreading them apart as assessed&#xD;
             by the investigator.&#xD;
&#xD;
          -  Excessively thick sebaceous skin or hypertrophic muscles in the upper third part of&#xD;
             the face.&#xD;
&#xD;
          -  Any surgery or scars in the glabellar area.&#xD;
&#xD;
          -  Marked facial asymmetry.&#xD;
&#xD;
          -  Eyelid ptosis.&#xD;
&#xD;
          -  Marked brow ptosis and/or dermatochalasis.&#xD;
&#xD;
          -  Ongoing severe or unstable medical conditions, e.g., systemic infection, or pulmonary&#xD;
             disease, at the discretion of the investigator.&#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>Merz Medical Expert</last_name>
    <role>Study Director</role>
    <affiliation>Merz Pharmaceuticals GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Testing of Beverly Hills, Merz Investigational Site #0010395</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Associates Inc., Merz Investigational Site #0010435</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cosmetic Laser Dermatology, Merz Investigational Site #0010321</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Maas Clinics, Merz Investigational Site #0010338</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Clinical Research Center, Merz Investigational Site #0010097</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Privatpraxis für Dermatologie und Ästhetische Medizin, Merz Investigational Site #0490306</name>
      <address>
        <city>Berlin</city>
        <zip>10707</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universität Hamburg, Fachrichtung Kosmetik und Körperpflege, Merz Investigational Site #0490095</name>
      <address>
        <city>Hamburg</city>
        <zip>20146</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatologische Gemeinschaftspraxis Dr. Prager und Partner, Merz Investigational Site #0490345</name>
      <address>
        <city>Hamburg</city>
        <zip>22609</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin &amp; Laser Center, Merz Investigational Site #0490362</name>
      <address>
        <city>Potsdam</city>
        <zip>14467</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <disposition_first_submitted>September 7, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>September 7, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 10, 2021</disposition_first_posted>
  <last_update_submitted>September 7, 2021</last_update_submitted>
  <last_update_submitted_qc>September 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2021</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</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
    <mesh_term>incobotulinumtoxinA</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 7, 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/NCT03806933
org study id: M602011015
secondary id: 2018-002743-28
nct id: NCT03806933
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the study is to investigate the safety and duration of effect following
      different doses of Botulinum Toxin A (NT 201) in the treatment of glabellar frown lines.
This prospective, randomized, double-blind, multi-Center clinical study consists of a two
      stage experimental main period comparing different dose groups, followed by an optional
      open-label extension (20 Units follow-up treatment).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Duration of effect as defined by time between treatment and relapse to baseline status
time frame: From time of treatment to up to 360 days
description: Effect is defined as improvement at maximum frown as assessed by the investigator on the Facial Wrinkle Scale (FWS)
measure: Duration of effect whereby effect is defined by a score of none (0) or mild (1) at maximum frown as assessed by the investigator according to FWS
time frame: From time of treatment to up to 360 days
measure: Duration of effect whereby effect is defined as 2-point improvement from baseline at maximum frown as assessed by the investigator according to FWS
time frame: From time of treatment to up to 360 days
measure: Percentage of subjects rated as none (0) or mild (1) at maximum frown by investigator's rating on FWS at Day 180
time frame: Day 180
measure: Percentage of subjects rated as none (0) or mild (1) at maximum frown by subject's rating on FWS at Day 180
time frame: Day 180
measure: Percentage of subjects rated as at least 1-point improvement compared to baseline at maximum frown by investigator's rating on FWS at Day 180
time frame: Day 180
measure: Percentage of subjects rated as at least 1-point improvement compared to baseline at maximum frown by subject's rating on FWS Subject at Day 180
time frame: Day 180
arm group label: NT 201 Dose group 1
arm group type: Experimental
description: Stage 1 and 2. Intramuscular injection into the glabellar area.
arm group label: NT 201 Dose group 2
arm group type: Experimental
description: Stage 1. Intramuscular injection into the glabellar area.
arm group label: NT 201 Dose group 3
arm group type: Experimental
description: Stage 1. Intramuscular injection into the glabellar area.
arm group label: NT 201 Dose group 4
arm group type: Experimental
description: Stage 2. Intramuscular injection into the glabellar area.
arm group label: NT 201 Dose group 5
arm group type: Experimental
description: Open Label Extension Period. Intramuscular injection into the glabellar area.
intervention type: Drug
intervention name: NT 201
description: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
arm group label: NT 201 Dose group 1
arm group label: NT 201 Dose group 2
arm group label: NT 201 Dose group 3
arm group label: NT 201 Dose group 4
arm group label: NT 201 Dose group 5
other name: IncobotulinumtoxinA
other name: Xeomin
other name: Botulinum toxin type A (150 kiloDalton), free from complexing proteins
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Merz Medical Expert
role: Study Director
affiliation: Merz Pharmaceuticals GmbH
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: United States
responsible party type: Sponsor
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
mesh term: incobotulinumtoxinA
sharing ipd: No
submitted: September 7, 2023