<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/NCT01732809</url>
  </required_header>
  <id_info>
    <org_study_id>11-2011</org_study_id>
    <nct_id>NCT01732809</nct_id>
  </id_info>
  <brief_title>Fields Of Effects Of Two Commercial Preparations Of Botulinum Toxin Type A At Equal Labeled Unit Doses</brief_title>
  <official_title>Fields of Effects of Two Commercial Preparations of Botulinum Toxin Type A at Equal Labeled Unit Doses</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>
      The purpose of this study is to assess the fields of anhydrotic effect (FAE) of&#xD;
      abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units),&#xD;
      comparing both sweat gland and muscle activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-center, randomized, double-blind study. All participants were&#xD;
      recruited from a research center in Porto Alegre, Brazil, and provided written informed&#xD;
      consent. The purpose of this study is to assess the fields of anhydrotic effect (FAE) of&#xD;
      abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units),&#xD;
      comparing both sweat gland and muscle activities. Nineteen patients were enrolled and&#xD;
      evaluations were performed at baseline and 28 days after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">November 2011</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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Horizontal Diameter of the Fields of Anhidrotic Effect</measure>
    <time_frame>28 days</time_frame>
    <description>The Horizontal Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)&#xD;
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.&#xD;
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vertical Diameter of the Fields of Anhidrotic Effect</measure>
    <time_frame>28 days</time_frame>
    <description>The Vertical Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)&#xD;
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.&#xD;
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area of the Fields of Anhidrotic Effect</measure>
    <time_frame>28 days</time_frame>
    <description>The area of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)&#xD;
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.&#xD;
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wrinkle Severity Scale (WSS) at Maximum Contraction</measure>
    <time_frame>Baseline and 28 days</time_frame>
    <description>It is a 4-point validated scale for forehead lines:&#xD;
0 - None&#xD;
- Mild&#xD;
- Moderate&#xD;
- Severe&#xD;
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines.&#xD;
Wrinkle scales are used to grade the muscular effects of botulinum toxin.&#xD;
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wrinkle Severity Scale (WSS) at Rest</measure>
    <time_frame>Baseline and 28 days</time_frame>
    <description>It its a 4-point validated scale for forehead lines:&#xD;
0 - None&#xD;
- Mild&#xD;
- Moderate&#xD;
- Severe&#xD;
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines.&#xD;
Wrinkle scales are used to grade the muscular effects of botulinum toxin.&#xD;
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evoked Compound Muscle Action Potentials (ECMAP)</measure>
    <time_frame>Baseline and 28 days</time_frame>
    <description>Amplitude of the evoked compound muscle action potentials in the frontalis muscle on stimulation of the facial nerve performed at baseline and visit 2 using surface electrodes on the forehead and electrical stimulation of the facial nerve according to standard neurophysiologic procedures.&#xD;
The amplitude of the ECMAP was performed by an experienced neurologist using an electromyography device (Teca Sapphire; Teca Corp).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Skin Wrinkling</condition>
  <arm_group>
    <arm_group_label>abobotulinumtoxin A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received abobotulinumtoxin A in one of the sides of the forehead.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>onabotulinumtoxin A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received onabotulinumtoxin A in one of the sides of the forehead.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AbobotulinumtoxinA (ABO)</intervention_name>
    <description>Isovolumetric (0.02 mL) doses of 2 units of abobotulinumtoxinA injected on one side of the forehead.</description>
    <arm_group_label>abobotulinumtoxin A</arm_group_label>
    <other_name>Dysport®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OnabotulinumtoxinA (ONA)</intervention_name>
    <description>Isovolumetric (0.02 mL) doses of 2 units of onabotulinumtoxinA injected on the other side of the forehead.</description>
    <arm_group_label>onabotulinumtoxin A</arm_group_label>
    <other_name>Botox®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed consent&#xD;
&#xD;
          2. Female subjects aged between 18 to 60 years&#xD;
&#xD;
          3. Phototype I to IV&#xD;
&#xD;
          4. Moderate to severe wrinkles in the forehead region on maximal contracture of the&#xD;
             frontalis muscle according to the Wrinkle Severity Scale&#xD;
&#xD;
          5. Subjects with the Minor Test* considered positive from grade 3 to 5 on the Minor test&#xD;
             sweat intensity scale, showing sweat on the forehead under standardized conditions&#xD;
&#xD;
          6. Medical history and clinical examination that, in the investigator's opinion, do not&#xD;
             prevent the subject from participating in the study or from using the proposed&#xD;
             medication&#xD;
&#xD;
          7. Negative urinary pregnancy test at the initial visit for women of childbearing&#xD;
             potential&#xD;
&#xD;
          8. Use of an effective contraceptive method (oral or injectable contraception,&#xD;
             abstinence, intrauterine device, diaphragm, hysterectomy or bilateral ovariectomy,&#xD;
             tubal attachment, condom, sponge, spermicide or partner with vasectomy) throughout the&#xD;
             study for women of childbearing potential&#xD;
&#xD;
          9. Subjects must agree not to undergo other dermatological or aesthetic treatments during&#xD;
             the study period *The Minor test must be the last test to be done. Only the subjects&#xD;
             who fulfill all the inclusion criteria above undergo the Minor test to check for&#xD;
             sweating in the frontal region. The graduation considered positive for inclusion in&#xD;
             the study will be 3 to 5.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or intention to become pregnant during the study period&#xD;
&#xD;
          2. Breastfeeding&#xD;
&#xD;
          3. Botulinum toxin treatments in the last 6 months&#xD;
&#xD;
          4. Subjects participating in other clinical studies&#xD;
&#xD;
          5. Any surgical procedure performed that has affected the frontal or orbicularis muscle,&#xD;
             previous blepharoplasty or eyebrow raising&#xD;
&#xD;
          6. Any cosmetic procedures, including fillers, or scars that may interfere with the&#xD;
             results of the study&#xD;
&#xD;
          7. Fronto-parietal alopecia according to the Norwood-Hamilton classification&#xD;
&#xD;
          8. Neoplastic, muscular or neurological diseases&#xD;
&#xD;
          9. Use of using aminoglycoside antibiotics or penicillamines, quinine or calcium channel&#xD;
             blockers or that they will use at any time during the study&#xD;
&#xD;
         10. Inflammatory or infectious processes at the application site&#xD;
&#xD;
         11. Evident facial asymmetry&#xD;
&#xD;
         12. History of adverse event, such as sensitivity to the components of the formula, ptosis&#xD;
             or any other adverse event that, in the investigator's opinion, prevents the research&#xD;
             subject from participating in the study&#xD;
&#xD;
         13. Myasthenia Gravis, Eaton-Lambert Syndrome and motor neuron disease&#xD;
&#xD;
         14. Coagulation disorders or use of anticoagulants&#xD;
&#xD;
         15. Autoimmune disease&#xD;
&#xD;
         16. History of poor adherence to treatments or who have shown lack of cooperation to&#xD;
             adhere to the study protocol&#xD;
&#xD;
         17. Any condition that, in the investigator's opinion, could compromise the results of the&#xD;
             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 M Hexsel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brazilian Center for Studies in Dermatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brazilian Center for Studies in Dermatology</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90550-141</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <results_first_submitted>August 13, 2020</results_first_submitted>
  <results_first_submitted_qc>November 23, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 17, 2020</results_first_posted>
  <last_update_submitted>November 23, 2020</last_update_submitted>
  <last_update_submitted_qc>November 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2020</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>wrinkles</keyword>
  <keyword>botulinum toxin</keyword>
  <keyword>abobotulinumtoxinA</keyword>
  <keyword>onabotulinumtoxinA</keyword>
  <keyword>field of anhydrotic effects</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group A</title>
          <description>Patients received 2U/0.02mL of reconstituted abobotulinumtoxinA on the right side of the forehead and 2U/0.02mL of reconstituted onabotulinumtoxinA on the left side.</description>
        </group>
        <group group_id="P2">
          <title>Group B</title>
          <description>Patients received 2U/0.02mL of reconstituted abobotulinumtoxinA on the left side of the forehead and 2U/0.02mL of reconstituted onabotulinumtoxinA on the right side.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Split-face study. Each patient was treated with abobotulinumtoxin A in one side of the forehead, and with onabotulinumtoxin A on the contralateral side. Sides were randomized.</population>
      <group_list>
        <group group_id="B1">
          <title>Group A</title>
          <description>Patients received 2U/0.02mL of reconstituted abobotulinumtoxinA on the right side of the forehead and 2U/0.02mL of reconstituted onabotulinumtoxinA on the left side.</description>
        </group>
        <group group_id="B2">
          <title>Group B</title>
          <description>Patients received 2U/0.02mL of reconstituted abobotulinumtoxinA on the left side of the forehead and 2U/0.02mL of reconstituted onabotulinumtoxinA on the right side.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="19"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>Sides of the forehead</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="38"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.7" spread="10.6"/>
                    <measurement group_id="B2" value="35.7" spread="9.1"/>
                    <measurement group_id="B3" value="39.0" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>Brazil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Horizontal Diameter of the Fields of Anhidrotic Effect</title>
        <description>The Horizontal Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)&#xD;
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.&#xD;
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.</description>
        <time_frame>28 days</time_frame>
        <population>Per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Abobotulinumtoxin A</title>
            <description>Patients were randomized to the side of the forehead (left or right) in which the products were administered.</description>
          </group>
          <group group_id="O2">
            <title>Onabotulinumtoxin A</title>
            <description>Patients were randomized to the side of the forehead (left or right) in which the products were administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Horizontal Diameter of the Fields of Anhidrotic Effect</title>
          <description>The Horizontal Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)&#xD;
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.&#xD;
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.</description>
          <population>Per protocol.</population>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.84" spread="0.14"/>
                    <measurement group_id="O2" value="1.24" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vertical Diameter of the Fields of Anhidrotic Effect</title>
        <description>The Vertical Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)&#xD;
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.&#xD;
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.</description>
        <time_frame>28 days</time_frame>
        <population>Per protocol</population>
        <group_list>
          <group group_id="O1">
            <title>Abobotulinumtoxin A</title>
            <description>Patients were randomized to the side of the forehead (left or right) in which the products were administered.</description>
          </group>
          <group group_id="O2">
            <title>Onabotulinumtoxin A</title>
            <description>Patients were randomized to the side of the forehead (left or right) in which the products were administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Vertical Diameter of the Fields of Anhidrotic Effect</title>
          <description>The Vertical Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)&#xD;
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.&#xD;
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.</description>
          <population>Per protocol</population>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.19" spread="0.19"/>
                    <measurement group_id="O2" value="1.50" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area of the Fields of Anhidrotic Effect</title>
        <description>The area of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)&#xD;
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.&#xD;
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.</description>
        <time_frame>28 days</time_frame>
        <population>Per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Abobotulinumtoxin A</title>
            <description>Patients were randomized to the side of the forehead (left or right) in which the products were administered.</description>
          </group>
          <group group_id="O2">
            <title>Onabotulinumtoxin A</title>
            <description>Patients were randomized to the side of the forehead (left or right) in which the products were administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Area of the Fields of Anhidrotic Effect</title>
          <description>The area of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)&#xD;
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.&#xD;
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.</description>
          <population>Per protocol.</population>
          <units>centimeters squared</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.86" spread="0.22"/>
                    <measurement group_id="O2" value="1.49" spread="0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Wrinkle Severity Scale (WSS) at Maximum Contraction</title>
        <description>It is a 4-point validated scale for forehead lines:&#xD;
0 - None&#xD;
- Mild&#xD;
- Moderate&#xD;
- Severe&#xD;
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines.&#xD;
Wrinkle scales are used to grade the muscular effects of botulinum toxin.&#xD;
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline.</description>
        <time_frame>Baseline and 28 days</time_frame>
        <population>Per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Abobotulinumtoxin A</title>
            <description>Patients were randomized to the side of the forehead (left or right) in which the products were administered.</description>
          </group>
          <group group_id="O2">
            <title>Onabotulinumtoxin A</title>
            <description>Patients were randomized to the side of the forehead (left or right) in which the products were administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Wrinkle Severity Scale (WSS) at Maximum Contraction</title>
          <description>It is a 4-point validated scale for forehead lines:&#xD;
0 - None&#xD;
- Mild&#xD;
- Moderate&#xD;
- Severe&#xD;
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines.&#xD;
Wrinkle scales are used to grade the muscular effects of botulinum toxin.&#xD;
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline.</description>
          <population>Per protocol.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline - Grade 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 28 days - Grade 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 28 days - Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 28 days - Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 28 days - Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Wrinkle Severity Scale (WSS) at Rest</title>
        <description>It its a 4-point validated scale for forehead lines:&#xD;
0 - None&#xD;
- Mild&#xD;
- Moderate&#xD;
- Severe&#xD;
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines.&#xD;
Wrinkle scales are used to grade the muscular effects of botulinum toxin.&#xD;
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline.</description>
        <time_frame>Baseline and 28 days</time_frame>
        <population>Per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Abobotulinumtoxin A</title>
            <description>Patients were randomized to the side of the forehead (left or right) in which the products were administered.</description>
          </group>
          <group group_id="O2">
            <title>Onabotulinumtoxin A</title>
            <description>Patients were randomized to the side of the forehead (left or right) in which the products were administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Wrinkle Severity Scale (WSS) at Rest</title>
          <description>It its a 4-point validated scale for forehead lines:&#xD;
0 - None&#xD;
- Mild&#xD;
- Moderate&#xD;
- Severe&#xD;
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines.&#xD;
Wrinkle scales are used to grade the muscular effects of botulinum toxin.&#xD;
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline.</description>
          <population>Per protocol.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline - Grade 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 28 days - Grade 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 28 days - Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 28 days - Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 28 days - Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evoked Compound Muscle Action Potentials (ECMAP)</title>
        <description>Amplitude of the evoked compound muscle action potentials in the frontalis muscle on stimulation of the facial nerve performed at baseline and visit 2 using surface electrodes on the forehead and electrical stimulation of the facial nerve according to standard neurophysiologic procedures.&#xD;
The amplitude of the ECMAP was performed by an experienced neurologist using an electromyography device (Teca Sapphire; Teca Corp).</description>
        <time_frame>Baseline and 28 days</time_frame>
        <population>Per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Abobotulinumtoxin A</title>
            <description>Patients were randomized to the side of the forehead (left or right) in which the products were administered.</description>
          </group>
          <group group_id="O2">
            <title>Onabotulinumtoxin A</title>
            <description>Patients were randomized to the side of the forehead (left or right) in which the products were administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Evoked Compound Muscle Action Potentials (ECMAP)</title>
          <description>Amplitude of the evoked compound muscle action potentials in the frontalis muscle on stimulation of the facial nerve performed at baseline and visit 2 using surface electrodes on the forehead and electrical stimulation of the facial nerve according to standard neurophysiologic procedures.&#xD;
The amplitude of the ECMAP was performed by an experienced neurologist using an electromyography device (Teca Sapphire; Teca Corp).</description>
          <population>Per protocol.</population>
          <units>microvolts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1108.17" spread="364.76"/>
                    <measurement group_id="O2" value="1079.11" spread="266.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="202.89" spread="258.44"/>
                    <measurement group_id="O2" value="165.39" spread="232.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Abobotulinumtoxin A</title>
          <description>Patients were randomized to the side of the forehead (left or right) in which the products were administered.</description>
        </group>
        <group group_id="E2">
          <title>Onabotulinumtoxin A</title>
          <description>Patients were randomized to the side of the forehead (left or right) in which the products were administered.</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="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <description>Erythema after injection procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Bleeding</sub_title>
                <description>Minimal bleeding after injection procedure</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </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>Scientific Coordinator</name_or_title>
      <organization>Brazilian Center for Studies in Dermatology</organization>
      <phone>+55 51 30262633</phone>
      <email>cientifico@cbed.org.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/NCT01732809
org study id: 11-2011
nct id: NCT01732809
lead sponsor: 
has dmc: No
The purpose of this study is to assess the fields of anhydrotic effect (FAE) of
      abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units),
      comparing both sweat gland and muscle activity.
This is a prospective, single-center, randomized, double-blind study. All participants were
      recruited from a research center in Porto Alegre, Brazil, and provided written informed
      consent. The purpose of this study is to assess the fields of anhydrotic effect (FAE) of
      abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units),
      comparing both sweat gland and muscle activities. Nineteen patients were enrolled and
      evaluations were performed at baseline and 28 days after treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Horizontal Diameter of the Fields of Anhidrotic Effect
time frame: 28 days
description: The Horizontal Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.
measure: Vertical Diameter of the Fields of Anhidrotic Effect
time frame: 28 days
description: The Vertical Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.
measure: Area of the Fields of Anhidrotic Effect
time frame: 28 days
description: The area of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.
measure: Wrinkle Severity Scale (WSS) at Maximum Contraction
time frame: Baseline and 28 days
description: It is a 4-point validated scale for forehead lines:
0 - None
- Mild
- Moderate
- Severe
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines.
Wrinkle scales are used to grade the muscular effects of botulinum toxin.
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline.
measure: Wrinkle Severity Scale (WSS) at Rest
time frame: Baseline and 28 days
description: It its a 4-point validated scale for forehead lines:
0 - None
- Mild
- Moderate
- Severe
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines.
Wrinkle scales are used to grade the muscular effects of botulinum toxin.
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline.
measure: Evoked Compound Muscle Action Potentials (ECMAP)
time frame: Baseline and 28 days
description: Amplitude of the evoked compound muscle action potentials in the frontalis muscle on stimulation of the facial nerve performed at baseline and visit 2 using surface electrodes on the forehead and electrical stimulation of the facial nerve according to standard neurophysiologic procedures.
The amplitude of the ECMAP was performed by an experienced neurologist using an electromyography device (Teca Sapphire; Teca Corp).
arm group label: abobotulinumtoxin A
arm group type: Active Comparator
description: Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received abobotulinumtoxin A in one of the sides of the forehead.
arm group label: onabotulinumtoxin A
arm group type: Active Comparator
description: Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received onabotulinumtoxin A in one of the sides of the forehead.
intervention type: Drug
intervention name: AbobotulinumtoxinA (ABO)
description: Isovolumetric (0.02 mL) doses of 2 units of abobotulinumtoxinA injected on one side of the forehead.
arm group label: abobotulinumtoxin A
other name: Dysport®
intervention type: Drug
intervention name: OnabotulinumtoxinA (ONA)
description: Isovolumetric (0.02 mL) doses of 2 units of onabotulinumtoxinA injected on the other side of the forehead.
arm group label: onabotulinumtoxin A
other name: Botox®
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Doris M Hexsel, MD
role: Principal Investigator
affiliation: Brazilian Center for Studies in Dermatology
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, Type A
mesh term: abobotulinumtoxinA
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 