<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/NCT01728337</url>
  </required_header>
  <id_info>
    <org_study_id>12-2012</org_study_id>
    <nct_id>NCT01728337</nct_id>
  </id_info>
  <brief_title>Phase IV Study On Muscle Activity Of Two Commercial Preparations Of Botulinum</brief_title>
  <official_title>Phase IV, Randomized, Double-blind Study on Muscle Activity of Two Commercial Preparations of Botulinum Toxin Type A (Dysport and Xeomin) Administered to the Upper Third of the Face (Forehead Lines).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brazilan Center for Studies in Dermatology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brazilan Center for Studies in Dermatology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      this study was proposed to provide more scientific and objective data on the clinical and&#xD;
      aesthetic effects of these two toxins (Dysport and Xeomin).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will perform 6 (six) visits during the study:&#xD;
&#xD;
      Screening visit, performed 30 to 1 day before the visit 1, when eligible subjects will be&#xD;
      recruited and first evaluations will be performed; visit 1, which is the baseline and when&#xD;
      the injections will be performed; visit 2, 30 +/- 3 days after the injections, when&#xD;
      evaluations will be performed; visit 3, 90 +/- 3 days after the injections, when evaluations&#xD;
      will be performed; 4, 120 +/- 3 days after the injections, when evaluations will be&#xD;
      performed; visit 5, 150 +/- 3 days after the injections, when evaluations will be performed.&#xD;
&#xD;
      Assessment of percentage (%) of responders, after 5 months of injection, to the effects of&#xD;
      two BT-A preparations, Dysport® and Xeomin®, by measuring frontalis m. wrinkle intensity at&#xD;
      maximum contraction, as measured by visual Wrinkles Severity Scale (WSS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</primary_completion_date>
  <phase>Phase 4</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>Percentage of Responders After 5 Months After the Procedure</measure>
    <time_frame>5 months after intervention</time_frame>
    <description>Percentage (%) of responders, after 5 months of injection, to the effects of two botulinum toxin type A (BT-A), Dysport® and Xeomin®. Responders were defined as individuals who presented at least 1 score less in the Wrinkles Scale Score (WSS) at maximum contraction compared to the WSS score at baseline.&#xD;
WSS is a validated 4-point scale, at rest and at maximum voluntary contraction of the frontalis muscle, in which 0 means no wrinkles up to 3 which means sever wrinkles.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Evoked Compound Muscle Action Potential</measure>
    <time_frame>5 months after the procedure.</time_frame>
    <description>To evaluate the duration, magnitude and peak of effects of two BT-A preparations, by measuring of the maximum Evoked Compound Muscle Action Potentials after contraction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Sun-induced Wrinkles</condition>
  <arm_group>
    <arm_group_label>Dysport and Xeomin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 U of Dysport® was injected on the right side of the forehead and 12 U Xeomin® was injected on the left side of the forehead (dose-equivalence 2.5:1).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Xeomin and Dysport</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 U Dysport® was injected on the left side of the forehead and 12 U Xeomin® was injected on the right side of the forehead (dose-equivalence 2.5:1).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dysport</intervention_name>
    <description>Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.</description>
    <arm_group_label>Dysport and Xeomin</arm_group_label>
    <arm_group_label>Xeomin and Dysport</arm_group_label>
    <other_name>botulinum toxin type A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xeomin</intervention_name>
    <description>Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead</description>
    <arm_group_label>Dysport and Xeomin</arm_group_label>
    <arm_group_label>Xeomin and Dysport</arm_group_label>
    <other_name>botulinum toxin type A</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject agreement to provide written informed consent and the willingness and ability&#xD;
             to comply with all aspects of the protocol;&#xD;
&#xD;
          -  Female subjects;&#xD;
&#xD;
          -  Phototype I to IV;&#xD;
&#xD;
          -  Subjects aged between 18 and 60 years;&#xD;
&#xD;
          -  Subjects naive for BT-A treatment;&#xD;
&#xD;
          -  Subjects presenting the same degree of moderate (2) to severe (3) wrinkles on the left&#xD;
             and right side of forehead under maximum voluntary contraction of the frontalis m.&#xD;
             according WSS;&#xD;
&#xD;
          -  Subjects with Minor's test showing at least grade III in the Sweating Intensity Visual&#xD;
             Scale;&#xD;
&#xD;
          -  Medical history and physical examination which, based on the investigator's opinion,&#xD;
             do not prevent the subject from taking part in the study or from making use of the&#xD;
             products under investigation;&#xD;
&#xD;
          -  Subjects of childbearing age should present a negative urine pregnancy test at&#xD;
             baseline and should be using a highly effective contraceptive method during all study;&#xD;
&#xD;
          -  Availability of the subject throughout the study (5 months);&#xD;
&#xD;
          -  Subject agreeing not to undergo other cosmetic or dermatological procedures during the&#xD;
             participation in the study;&#xD;
&#xD;
          -  Subjects with sufficient schooling and knowledge to enable them to cooperate to the&#xD;
             degree required by the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women or women intending to become pregnant in the following 5 months after&#xD;
             screening;&#xD;
&#xD;
          -  Lactation period;&#xD;
&#xD;
          -  Subjects participating in other clinical trials;&#xD;
&#xD;
          -  Any prior surgery affecting the frontalis and/or orbicularis muscles, prior&#xD;
             blepharoplasty or brow lift;&#xD;
&#xD;
          -  Any prior cosmetic procedures, including fillers, or scars that may interfere with the&#xD;
             study results;&#xD;
&#xD;
          -  Subjects with neoplastic, muscular or neurological diseases;&#xD;
&#xD;
          -  Subjects taking aminoglycoside and penicillamine antibiotics, quinine or Ca2+ channel&#xD;
             blockers;&#xD;
&#xD;
          -  Subjects with inflammation or active infection in the area to be injected;&#xD;
&#xD;
          -  Subjects presenting evident facial asymmetry;&#xD;
&#xD;
          -  Subjects with a history of adverse effects, such as sensitivity to the components of&#xD;
             any of the study drug formula, ptosis or any other adverse effect which, in the&#xD;
             investigator's opinion, should prevent the subject from participating in the study;&#xD;
&#xD;
          -  Subjects presenting Myasthenia Gravis, Eaton-Lambert Syndrome and motor neuron&#xD;
             disease;&#xD;
&#xD;
          -  Subjects with coagulation disorders or taking anticoagulants;&#xD;
&#xD;
          -  Subjects with known systemic autoimmune diseases;&#xD;
&#xD;
          -  Subjects with a history of non-adherence to medical treatment or showing unwillingness&#xD;
             to adhere to the study protocol;&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator, can compromise the evaluation&#xD;
             of the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Doris Hexsel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brazilian Center for Dermatologic Studies</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brazilian Center For Studies in Dermatology</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <results_first_submitted>January 28, 2013</results_first_submitted>
  <results_first_submitted_qc>July 22, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 11, 2014</results_first_posted>
  <last_update_submitted>July 15, 2019</last_update_submitted>
  <last_update_submitted_qc>July 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brazilan Center for Studies in Dermatology</investigator_affiliation>
    <investigator_full_name>Doris Hexsel</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>botulinum toxin,</keyword>
  <keyword>wrinkles</keyword>
  <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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All patients included in this study were recruted from two research centers.</recruitment_details>
      <pre_assignment_details>We did not have any drop-out in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Dysport and Xeomin</title>
          <description>Dysport® was injected on the one side of the forehead and Xeomin® was injected on the other side of the forehead.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Xeomin and Dysport</title>
          <description>Xeomin® was injected on the one side of the forehead and Dysport® was injected on the other side of the forehead.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Brazil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Evoked Compound Muscle Action Potentials</title>
          <description>The Evoked Compound Muscle Action Potentials (CMAP) is the sum of the action potentials of individual muscle fibers obtained by stimulating a motor nerve. It is obtained through a set surface electrode on the point of the motor muscle and a reference electrode placed on an electrically neutral area (usually on a tendon). The amplitude of the CMAP reflects the number of muscle fibers depolarized in response to a stimulus and is measured in millivolts (mV).</description>
          <units>mV</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1053" spread="282"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Responders After 5 Months After the Procedure</title>
        <description>Percentage (%) of responders, after 5 months of injection, to the effects of two botulinum toxin type A (BT-A), Dysport® and Xeomin®. Responders were defined as individuals who presented at least 1 score less in the Wrinkles Scale Score (WSS) at maximum contraction compared to the WSS score at baseline.&#xD;
WSS is a validated 4-point scale, at rest and at maximum voluntary contraction of the frontalis muscle, in which 0 means no wrinkles up to 3 which means sever wrinkles.</description>
        <time_frame>5 months after intervention</time_frame>
        <population>80 sujbects were included in this study, each patient have received both products in their faces. The randomization was performed to define the side for each product.</population>
        <group_list>
          <group group_id="O1">
            <title>Dysport</title>
            <description>Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.</description>
          </group>
          <group group_id="O2">
            <title>Xeomin</title>
            <description>Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders After 5 Months After the Procedure</title>
          <description>Percentage (%) of responders, after 5 months of injection, to the effects of two botulinum toxin type A (BT-A), Dysport® and Xeomin®. Responders were defined as individuals who presented at least 1 score less in the Wrinkles Scale Score (WSS) at maximum contraction compared to the WSS score at baseline.&#xD;
WSS is a validated 4-point scale, at rest and at maximum voluntary contraction of the frontalis muscle, in which 0 means no wrinkles up to 3 which means sever wrinkles.</description>
          <population>80 sujbects were included in this study, each patient have received both products in their faces. The randomization was performed to define the side for each product.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Evoked Compound Muscle Action Potential</title>
        <description>To evaluate the duration, magnitude and peak of effects of two BT-A preparations, by measuring of the maximum Evoked Compound Muscle Action Potentials after contraction.</description>
        <time_frame>5 months after the procedure.</time_frame>
        <population>All subjects have received both treatments.</population>
        <group_list>
          <group group_id="O1">
            <title>Dysport</title>
            <description>Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.</description>
          </group>
          <group group_id="O2">
            <title>Xeomin</title>
            <description>Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Evoked Compound Muscle Action Potential</title>
          <description>To evaluate the duration, magnitude and peak of effects of two BT-A preparations, by measuring of the maximum Evoked Compound Muscle Action Potentials after contraction.</description>
          <population>All subjects have received both treatments.</population>
          <units>mV</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="694" spread="391"/>
                    <measurement group_id="O2" value="677" spread="387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Dysport</title>
          <description>Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.</description>
        </group>
        <group group_id="E2">
          <title>Xeomin</title>
          <description>Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1.25</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="80"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Worsening of Glabellar frown lines</sub_title>
                <description>Worsening of Glabellar frown lines, transitory and related to the study medication.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Injection site bleeding</sub_title>
                <assessment>Systematic Assessment</assessment>
                <description>Injection site bleeding, not related to the study medication. It was associated to the injection.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Doris Hexsel</name_or_title>
      <organization>CBED</organization>
      <phone>30262633</phone>
      <email>cbed@cbed.com.br</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01728337
org study id: 12-2012
nct id: NCT01728337
lead sponsor: 
has dmc: No
this study was proposed to provide more scientific and objective data on the clinical and
      aesthetic effects of these two toxins (Dysport and Xeomin).
Subjects will perform 6 (six) visits during the study:

      Screening visit, performed 30 to 1 day before the visit 1, when eligible subjects will be
      recruited and first evaluations will be performed; visit 1, which is the baseline and when
      the injections will be performed; visit 2, 30 +/- 3 days after the injections, when
      evaluations will be performed; visit 3, 90 +/- 3 days after the injections, when evaluations
      will be performed; 4, 120 +/- 3 days after the injections, when evaluations will be
      performed; visit 5, 150 +/- 3 days after the injections, when evaluations will be performed.

      Assessment of percentage (%) of responders, after 5 months of injection, to the effects of
      two BT-A preparations, Dysport® and Xeomin®, by measuring frontalis m. wrinkle intensity at
      maximum contraction, as measured by visual Wrinkles Severity Scale (WSS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Responders After 5 Months After the Procedure
time frame: 5 months after intervention
description: Percentage (%) of responders, after 5 months of injection, to the effects of two botulinum toxin type A (BT-A), Dysport® and Xeomin®. Responders were defined as individuals who presented at least 1 score less in the Wrinkles Scale Score (WSS) at maximum contraction compared to the WSS score at baseline.
WSS is a validated 4-point scale, at rest and at maximum voluntary contraction of the frontalis muscle, in which 0 means no wrinkles up to 3 which means sever wrinkles.
measure: Maximum Evoked Compound Muscle Action Potential
time frame: 5 months after the procedure.
description: To evaluate the duration, magnitude and peak of effects of two BT-A preparations, by measuring of the maximum Evoked Compound Muscle Action Potentials after contraction.
arm group label: Dysport and Xeomin
arm group type: Active Comparator
description: 30 U of Dysport® was injected on the right side of the forehead and 12 U Xeomin® was injected on the left side of the forehead (dose-equivalence 2.5:1).
arm group label: Xeomin and Dysport
arm group type: Active Comparator
description: 30 U Dysport® was injected on the left side of the forehead and 12 U Xeomin® was injected on the right side of the forehead (dose-equivalence 2.5:1).
intervention type: Drug
intervention name: Dysport
description: Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
arm group label: Dysport and Xeomin
arm group label: Xeomin and Dysport
other name: botulinum toxin type A
intervention type: Drug
intervention name: Xeomin
description: Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead
arm group label: Dysport and Xeomin
arm group label: Xeomin and Dysport
other name: botulinum toxin type A
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Doris Hexsel, MD
role: Principal Investigator
affiliation: Brazilian Center for Dermatologic Studies
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Brazilan Center for Studies in Dermatology
investigator full name: Doris Hexsel
investigator title: MD
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 