<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/NCT03799484</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-18-0908</org_study_id>
    <nct_id>NCT03799484</nct_id>
  </id_info>
  <brief_title>Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment</brief_title>
  <official_title>Randomized, Single Center, Masked Study Comparing the Efficacy of Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Robert Cizik Eye Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether there is a difference in clinical effect,&#xD;
      duration of effect, level of discomfort and patient satisfaction in patients receiving&#xD;
      topical anesthesia on one side of the forehead and petrolatum ointment on the other prior to&#xD;
      Botulinum Toxin Type A administration for the treatment of forehead rhytides.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, double-masked, comparative study in patients who present&#xD;
      at the Robert Cizik Eye Clinic with horizontal forehead rhytides requiring treatment with&#xD;
      botulinum toxin Type A (Botox ®; Allergan, Irvine, CA, USA).&#xD;
&#xD;
      The objective of this study is to determine whether there is a difference in clinical effect&#xD;
      (weakness/paralysis of the frontalis muscle), duration of effect, level of discomfort and&#xD;
      patient satisfaction in patients receiving topical anesthesia (2.5% lidocaine/2.5 %&#xD;
      prilocaine cream, Impax Laboratories, LLC) on one side of the forehead and petrolatum&#xD;
      ointment on the other prior to BTX-A administration for the treatment of forehead rhytides.&#xD;
&#xD;
        -  Primary outcome variable is change of eyebrow excursion on each side of the forehead&#xD;
           from baseline to each follow-up visit.&#xD;
&#xD;
        -  Secondary outcome variables&#xD;
&#xD;
             -  Duration of effect, defined as the elapsed time from injection to the end of&#xD;
                botulinum, such that return of baseline frontalis function, i.e. within 2 mm of&#xD;
                baseline value&#xD;
&#xD;
             -  Perception of pain immediately after injection at each side&#xD;
&#xD;
             -  Patient satisfaction for each side&#xD;
&#xD;
             -  Patient's perception of difference in efficacy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2019</start_date>
  <completion_date type="Actual">June 14, 2019</completion_date>
  <primary_completion_date type="Actual">June 14, 2019</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, Outcomes Assessor)</masking>
    <masking_description>Randomization will only be known by the principal investigator performing the injections and will not be disclosed to the participants or the brow excursion examiner.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Eyebrow Excursion</measure>
    <time_frame>Baseline</time_frame>
    <description>Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Eyebrow Excursion</measure>
    <time_frame>Week 2</time_frame>
    <description>Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Eyebrow Excursion</measure>
    <time_frame>Week 6</time_frame>
    <description>Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Eyebrow Excursion</measure>
    <time_frame>week 16</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Botulinum Toxin Type A Effect</measure>
    <time_frame>week 16</time_frame>
    <description>Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale</measure>
    <time_frame>Immediately after botox injection</time_frame>
    <description>A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey</measure>
    <time_frame>Week 2</time_frame>
    <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey</measure>
    <time_frame>Week 6</time_frame>
    <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey</measure>
    <time_frame>Week 16</time_frame>
    <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey</measure>
    <time_frame>Week 2</time_frame>
    <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey</measure>
    <time_frame>Week 6</time_frame>
    <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey</measure>
    <time_frame>Week 16</time_frame>
    <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey</measure>
    <time_frame>Week 2</time_frame>
    <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey</measure>
    <time_frame>Week 6</time_frame>
    <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey</measure>
    <time_frame>Week 16</time_frame>
    <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face</measure>
    <time_frame>Week 2</time_frame>
    <description>Participants will be asked if there is a noticeable difference between the 2 sides of their face.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face</measure>
    <time_frame>Week 6</time_frame>
    <description>Participants will be asked if there is a noticeable difference between the 2 sides of their face.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face</measure>
    <time_frame>Week 16</time_frame>
    <description>Participants will be asked if there is a noticeable difference between the 2 sides of their face.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Forehead Rhytides</condition>
  <condition>Forehead Wrinkles</condition>
  <arm_group>
    <arm_group_label>Topical Anesthesia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Petrolatum</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum toxin type A</intervention_name>
    <description>Botulinum toxin type A will be administered to both sides</description>
    <arm_group_label>Petrolatum</arm_group_label>
    <arm_group_label>Topical Anesthesia</arm_group_label>
    <other_name>BTX-A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2.5% lidocaine/2.5% prilocaine</intervention_name>
    <description>2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead</description>
    <arm_group_label>Topical Anesthesia</arm_group_label>
    <other_name>EMLA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>petrolatum ointment</intervention_name>
    <description>petrolatum ointment will be applied to one side of the forehead</description>
    <arm_group_label>Petrolatum</arm_group_label>
    <other_name>Aquaphor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 65 years of age&#xD;
&#xD;
          -  Presence of horizontal forehead rhytides&#xD;
&#xD;
          -  Good eyebrow excursion (greater than or equal to 5 mm)&#xD;
&#xD;
          -  Able to understand and sign an informed consent form that has been approved by the&#xD;
             Committee for the Protection of Human Subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous injection of botulinum toxin in the intended treatment area for the study&#xD;
             within the last 4 months&#xD;
&#xD;
          -  Known allergy to botulinum toxin&#xD;
&#xD;
          -  Known history of sensitivity to local anesthetics of the amide type&#xD;
&#xD;
          -  Existing disorder of neuromuscular transmission&#xD;
&#xD;
          -  Usage of medication with effect on neuromuscular function&#xD;
&#xD;
          -  Women of childbearing potential (who are not postmenopausal for at least 1 year or&#xD;
             surgically sterile), who are pregnant or nursing or intend to become pregnant during&#xD;
             the time of the study&#xD;
&#xD;
          -  Significant brow asymmetry (&gt; 5mm)&#xD;
&#xD;
          -  Unable to follow-up for the duration of the study (16 weeks)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karina Richani-Reverol, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Robert Cizik Eye Clinic</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Scott AB. Botulinum toxin injection into extraocular muscles as an alternative to strabismus surgery. J Pediatr Ophthalmol Strabismus. 1980 Jan-Feb;17(1):21-5. doi: 10.3928/0191-3913-19800101-06.</citation>
    <PMID>7365644</PMID>
  </reference>
  <reference>
    <citation>Carruthers A, Carruthers J. Clinical indications and injection technique for the cosmetic use of botulinum A exotoxin. Dermatol Surg. 1998 Nov;24(11):1189-94. doi: 10.1111/j.1524-4725.1998.tb04097.x.</citation>
    <PMID>9834738</PMID>
  </reference>
  <reference>
    <citation>Carter SR, Seiff SR. Cosmetic botulinum toxin injections. Int Ophthalmol Clin. 1997 Summer;37(3):69-79. doi: 10.1097/00004397-199703730-00006. No abstract available.</citation>
    <PMID>9279643</PMID>
  </reference>
  <reference>
    <citation>Charles PD. Botulinum neurotoxin serotype A: a clinical update on non-cosmetic uses. Am J Health Syst Pharm. 2004 Nov 15;61(22 Suppl 6):S11-23. doi: 10.1093/ajhp/61.suppl_6.S11.</citation>
    <PMID>15598005</PMID>
  </reference>
  <reference>
    <citation>Carruthers A, Carruthers J. Aesthetic indications for botulinum toxin injections. Plast Reconstr Surg. 1995 Feb;95(2):427-8. doi: 10.1097/00006534-199502000-00049. No abstract available.</citation>
    <PMID>7824641</PMID>
  </reference>
  <reference>
    <citation>Clark RP, Berris CE. Botulinum toxin: a treatment for facial asymmetry caused by facial nerve paralysis. Plast Reconstr Surg. 1989 Aug;84(2):353-5.</citation>
    <PMID>2748749</PMID>
  </reference>
  <reference>
    <citation>Sami MS, Soparkar CN, Patrinely JR, Hollier LM, Hollier LH. Efficacy of botulinum toxin type a after topical anesthesia. Ophthalmic Plast Reconstr Surg. 2006 Nov-Dec;22(6):448-52. doi: 10.1097/01.iop.0000248989.33572.3c.</citation>
    <PMID>17117100</PMID>
  </reference>
  <reference>
    <citation>Gordin EA, Luginbuhl AL, Ortlip T, Heffelfinger RN, Krein H. Subcutaneous vs intramuscular botulinum toxin: split-face randomized study. JAMA Facial Plast Surg. 2014 May-Jun;16(3):193-8. doi: 10.1001/jamafacial.2013.2458.</citation>
    <PMID>24699554</PMID>
  </reference>
  <reference>
    <citation>Li Y, Dong W, Wang M, Xu N. Investigation of the Efficacy and Safety of Topical Vibration Anesthesia to Reduce Pain From Cosmetic Botulinum Toxin A Injections in Chinese Patients: A Multicenter, Randomized, Self-Controlled Study. Dermatol Surg. 2017 Dec;43 Suppl 3:S329-S335. doi: 10.1097/DSS.0000000000001349.</citation>
    <PMID>29016544</PMID>
  </reference>
  <reference>
    <citation>Shi LL, Sargen MR, Chen SC, Arbiser JL, Pollack BP. Effective local anesthesia for onabotulinumtoxin A injections to treat hyperhidrosis associated with traumatic amputation. Dermatol Online J. 2016 Jun 15;22(6):13030/qt38b203d0.</citation>
    <PMID>27617615</PMID>
  </reference>
  <reference>
    <citation>Baumann LS, Grunebaum L, Elsaie ML, Murdock J, Jablonka E, Figueras K, Bell M. Safety and efficacy of a rapid-acting topical 4% lidocaine gel in a unique drug delivery system. J Drugs Dermatol. 2010 Dec;9(12):1500-4.</citation>
    <PMID>21120257</PMID>
  </reference>
  <reference>
    <citation>Weiss RA, Lavin PT. Reduction of pain and anxiety prior to botulinum toxin injections with a new topical anesthetic method. Ophthalmic Plast Reconstr Surg. 2009 May-Jun;25(3):173-7. doi: 10.1097/IOP.0b013e3181a145ca.</citation>
    <PMID>19454924</PMID>
  </reference>
  <reference>
    <citation>Alam M, Bolotin D, Carruthers J, Hexsel D, Lawrence N, Minkis K, Ross EV. Consensus statement regarding storage and reuse of previously reconstituted neuromodulators. Dermatol Surg. 2015 Mar;41(3):321-6. doi: 10.1097/DSS.0000000000000303.</citation>
    <PMID>25705950</PMID>
  </reference>
  <reference>
    <citation>Carruthers J, Fagien S, Matarasso SL; Botox Consensus Group. Consensus recommendations on the use of botulinum toxin type a in facial aesthetics. Plast Reconstr Surg. 2004 Nov;114(6 Suppl):1S-22S. doi: 10.1097/01.PRS.0000144795.76040.D3.</citation>
    <PMID>15507786</PMID>
  </reference>
  <reference>
    <citation>Ito H, Ito H, Nakano S, Kusaka H. Low-dose subcutaneous injection of botulinum toxin type A for facial synkinesis and hyperlacrimation. Acta Neurol Scand. 2007 Apr;115(4):271-4. doi: 10.1111/j.1600-0404.2006.00746.x.</citation>
    <PMID>17376126</PMID>
  </reference>
  <reference>
    <citation>Tzou CH, Giovanoli P, Ploner M, Frey M. Are there ethnic differences of facial movements between Europeans and Asians? Br J Plast Surg. 2005 Mar;58(2):183-95. doi: 10.1016/j.bjps.2004.10.014.</citation>
    <PMID>15710113</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <results_first_submitted>June 1, 2020</results_first_submitted>
  <results_first_submitted_qc>June 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 18, 2020</results_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Karina Richani-Reverol</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Rhytides</keyword>
  <keyword>Forehead Wrinkles</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Prilocaine</mesh_term>
    <mesh_term>Petrolatum</mesh_term>
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03799484/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>All Participants</title>
          <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </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>All Participants</title>
          <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="35.5" spread="6.7"/>
                  </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="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Distance between both lateral canthi</title>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="98.29" spread="3.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Eyebrow Excursion</title>
        <description>Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topical Anesthesia</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection&#xD;
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides&#xD;
2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead</description>
          </group>
          <group group_id="O2">
            <title>Petrolatum</title>
            <description>Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection&#xD;
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides&#xD;
petrolatum ointment: petrolatum ointment will be applied to one side of the forehead</description>
          </group>
        </group_list>
        <measure>
          <title>Eyebrow Excursion</title>
          <description>Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.</description>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>side of forehead (either left or right)</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>side of forehead (either left or right)</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.57" spread="3.3"/>
                    <measurement group_id="O2" value="10.57" spread="3.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Eyebrow Excursion</title>
        <description>Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topical Anesthesia</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection&#xD;
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides&#xD;
2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead</description>
          </group>
          <group group_id="O2">
            <title>Petrolatum</title>
            <description>Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection&#xD;
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides&#xD;
petrolatum ointment: petrolatum ointment will be applied to one side of the forehead</description>
          </group>
        </group_list>
        <measure>
          <title>Eyebrow Excursion</title>
          <description>Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.</description>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>side of forehead (either left or right)</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>side of forehead (either left or right)</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.46" spread="2.76"/>
                    <measurement group_id="O2" value="3.43" spread="2.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Eyebrow Excursion</title>
        <description>Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.</description>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topical Anesthesia</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection&#xD;
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides&#xD;
2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead</description>
          </group>
          <group group_id="O2">
            <title>Petrolatum</title>
            <description>Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection&#xD;
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides&#xD;
petrolatum ointment: petrolatum ointment will be applied to one side of the forehead</description>
          </group>
        </group_list>
        <measure>
          <title>Eyebrow Excursion</title>
          <description>Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.</description>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>side of forehead (either left or right)</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>side of forehead (either left or right)</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.96" spread="2.62"/>
                    <measurement group_id="O2" value="5.68" spread="2.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Eyebrow Excursion</title>
        <time_frame>week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topical Anesthesia</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection&#xD;
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides&#xD;
2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead</description>
          </group>
          <group group_id="O2">
            <title>Petrolatum</title>
            <description>Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection&#xD;
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides&#xD;
petrolatum ointment: petrolatum ointment will be applied to one side of the forehead</description>
          </group>
        </group_list>
        <measure>
          <title>Eyebrow Excursion</title>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>side of forehead (either left or right)</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>side of forehead (either left or right)</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.21" spread="2.89"/>
                    <measurement group_id="O2" value="8.07" spread="2.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Botulinum Toxin Type A Effect</title>
        <description>Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value.</description>
        <time_frame>week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topical Anesthesia</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection&#xD;
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides&#xD;
2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead</description>
          </group>
          <group group_id="O2">
            <title>Petrolatum</title>
            <description>Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection&#xD;
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides&#xD;
petrolatum ointment: petrolatum ointment will be applied to one side of the forehead</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Botulinum Toxin Type A Effect</title>
          <description>Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value.</description>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <units_analyzed>side of forehead (either left or right)</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>side of forehead (either left or right)</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.2857" spread="1.2317"/>
                    <measurement group_id="O2" value="15.2857" spread="0.7301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale</title>
        <description>A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome.</description>
        <time_frame>Immediately after botox injection</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topical Anesthesia</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection&#xD;
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides&#xD;
2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead</description>
          </group>
          <group group_id="O2">
            <title>Petrolatum</title>
            <description>Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection&#xD;
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides&#xD;
petrolatum ointment: petrolatum ointment will be applied to one side of the forehead</description>
          </group>
        </group_list>
        <measure>
          <title>Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale</title>
          <description>A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>side of forehead (either left or right)</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>side of forehead (either left or right)</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.43" spread="1.55"/>
                    <measurement group_id="O2" value="3.96" spread="1.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey</title>
        <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey</title>
          <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>very satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neutral</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey</title>
        <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey</title>
          <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>very satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neutral</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey</title>
        <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
        <time_frame>Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey</title>
          <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>very satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neutral</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey</title>
        <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey</title>
          <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>very satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neutral</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey</title>
        <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey</title>
          <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>very satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neutral</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey</title>
        <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
        <time_frame>Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey</title>
          <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>very satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neutral</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey</title>
        <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey</title>
          <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>very satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neutral</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey</title>
        <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey</title>
          <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>very satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neutral</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey</title>
        <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
        <time_frame>Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey</title>
          <description>The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>very satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neutral</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face</title>
        <description>Participants will be asked if there is a noticeable difference between the 2 sides of their face.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face</title>
          <description>Participants will be asked if there is a noticeable difference between the 2 sides of their face.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face</title>
        <description>Participants will be asked if there is a noticeable difference between the 2 sides of their face.</description>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face</title>
          <description>Participants will be asked if there is a noticeable difference between the 2 sides of their face.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face</title>
        <description>Participants will be asked if there is a noticeable difference between the 2 sides of their face.</description>
        <time_frame>Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face</title>
          <description>Participants will be asked if there is a noticeable difference between the 2 sides of their face.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>16 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Topical Anesthesia</title>
          <description>2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection&#xD;
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides&#xD;
2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead</description>
        </group>
        <group group_id="E2">
          <title>Petrolatum</title>
          <description>Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection&#xD;
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides&#xD;
petrolatum ointment: petrolatum ointment will be applied to one side of the forehead</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Karina Richani-Reverol, MD</name_or_title>
      <organization>The University of Texas Health Science Center at Houston</organization>
      <phone>(713) 559-5200</phone>
      <email>Karina.RichaniReverol@uth.tmc.edu</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/NCT03799484
org study id: HSC-MS-18-0908
nct id: NCT03799484
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to determine whether there is a difference in clinical effect,
      duration of effect, level of discomfort and patient satisfaction in patients receiving
      topical anesthesia on one side of the forehead and petrolatum ointment on the other prior to
      Botulinum Toxin Type A administration for the treatment of forehead rhytides.
This is a prospective, randomized, double-masked, comparative study in patients who present
      at the Robert Cizik Eye Clinic with horizontal forehead rhytides requiring treatment with
      botulinum toxin Type A (Botox ®; Allergan, Irvine, CA, USA).

      The objective of this study is to determine whether there is a difference in clinical effect
      (weakness/paralysis of the frontalis muscle), duration of effect, level of discomfort and
      patient satisfaction in patients receiving topical anesthesia (2.5% lidocaine/2.5 %
      prilocaine cream, Impax Laboratories, LLC) on one side of the forehead and petrolatum
      ointment on the other prior to BTX-A administration for the treatment of forehead rhytides.

        -  Primary outcome variable is change of eyebrow excursion on each side of the forehead
           from baseline to each follow-up visit.

        -  Secondary outcome variables

             -  Duration of effect, defined as the elapsed time from injection to the end of
                botulinum, such that return of baseline frontalis function, i.e. within 2 mm of
                baseline value

             -  Perception of pain immediately after injection at each side

             -  Patient satisfaction for each side

             -  Patient's perception of difference in efficacy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
masking description: Randomization will only be known by the principal investigator performing the injections and will not be disclosed to the participants or the brow excursion examiner.
measure: Eyebrow Excursion
time frame: Baseline
description: Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.
measure: Eyebrow Excursion
time frame: Week 2
description: Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.
measure: Eyebrow Excursion
time frame: Week 6
description: Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.
measure: Eyebrow Excursion
time frame: week 16
measure: Duration of Botulinum Toxin Type A Effect
time frame: week 16
description: Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value.
measure: Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale
time frame: Immediately after botox injection
description: A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome.
measure: Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey
time frame: Week 2
description: The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.
measure: Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey
time frame: Week 6
description: The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.
measure: Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey
time frame: Week 16
description: The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.
measure: Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey
time frame: Week 2
description: The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.
measure: Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey
time frame: Week 6
description: The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.
measure: Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey
time frame: Week 16
description: The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.
measure: Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey
time frame: Week 2
description: The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.
measure: Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey
time frame: Week 6
description: The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.
measure: Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey
time frame: Week 16
description: The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.
measure: Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face
time frame: Week 2
description: Participants will be asked if there is a noticeable difference between the 2 sides of their face.
measure: Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face
time frame: Week 6
description: Participants will be asked if there is a noticeable difference between the 2 sides of their face.
measure: Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face
time frame: Week 16
description: Participants will be asked if there is a noticeable difference between the 2 sides of their face.
arm group label: Topical Anesthesia
arm group type: Other
description: 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection
arm group label: Petrolatum
arm group type: Other
description: Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection
intervention type: Drug
intervention name: Botulinum toxin type A
description: Botulinum toxin type A will be administered to both sides
arm group label: Petrolatum
arm group label: Topical Anesthesia
other name: BTX-A
intervention type: Drug
intervention name: 2.5% lidocaine/2.5% prilocaine
description: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead
arm group label: Topical Anesthesia
other name: EMLA
intervention type: Device
intervention name: petrolatum ointment
description: petrolatum ointment will be applied to one side of the forehead
arm group label: Petrolatum
other name: Aquaphor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Karina Richani-Reverol, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
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PMID: 15710113
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Karina Richani-Reverol
investigator title: Clinical Assistant Professor
mesh term: Lidocaine
mesh term: Prilocaine
mesh term: Petrolatum
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
sharing ipd: No
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