<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/NCT03284047</url>
  </required_header>
  <id_info>
    <org_study_id>STU00205065</org_study_id>
    <nct_id>NCT03284047</nct_id>
  </id_info>
  <brief_title>Botox for Gummy Smile</brief_title>
  <official_title>Evaluation of Different Doses of Botulinum Toxin Type A for the Treatment of Gummy Smile</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</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>
      This is a two part study to measure and observe the efficacy of botulinum toxin A for the&#xD;
      treatment of gummy smiles.&#xD;
&#xD;
      Part A will randomly compare three different doses of botulinum toxin type A&#xD;
      (abobotulinumtoxin A) for the treatment of upper anterior gummy smile with larger gingival&#xD;
      exposure (&gt; 4 mm).&#xD;
&#xD;
      Part B will assign one of two doses of botulinum toxin type A for participants with smaller&#xD;
      gingival exposure (&lt; 4 mm).&#xD;
&#xD;
      Follow-up visits with photography will occur 4 and 12 weeks after their treatment. Subjects&#xD;
      currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will&#xD;
      be considered for enrollment.&#xD;
&#xD;
      This study is a pilot study designed to determine feasibility of this procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study never started.&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 24, 2019</start_date>
  <completion_date type="Anticipated">April 24, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 24, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of the upper gum exposure at 4 weeks and 12 weeks.</measure>
    <time_frame>[Baseline, 4 weeks,12 weeks]</time_frame>
    <description>Reduction in millimeters in the upper gum exposure of subjects after botulinum toxin type A (abobotulinumtoxin A) treatment.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Gingival Exposure</condition>
  <arm_group>
    <arm_group_label>2.5 U dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with more than 4 mm of upper anterior gingival exposure measured from the central incisor tooth will be randomly assigned (1:1:1) to receive different doses of botulinum toxin type A (abobotulinumtoxin A) on the levator labii superioris alaeque nasi as follows:&#xD;
2.5 U&#xD;
5 U&#xD;
7.5 U</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 U dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with more than 4 mm of upper anterior gingival exposure measured from the central incisor tooth will be randomly assigned (1:1:1) to receive different doses of botulinum toxin type A (abobotulinumtoxin A) on the levator labii superioris alaeque nasi as follows:&#xD;
2.5 U&#xD;
5 U&#xD;
7.5 U</description>
  </arm_group>
  <arm_group>
    <arm_group_label>7.5 U dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with more than 4 mm of upper anterior gingival exposure measured from the central incisor tooth will be randomly assigned (1:1:1) to receive different doses of botulinum toxin type A (abobotulinumtoxin A) on the levator labii superioris alaeque nasi as follows:&#xD;
2.5 U&#xD;
5 U&#xD;
7.5 U</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum toxin type A</intervention_name>
    <description>Participants will be randomized to one of three botulinum toxin type A doses.</description>
    <arm_group_label>2.5 U dose</arm_group_label>
    <arm_group_label>5 U dose</arm_group_label>
    <arm_group_label>7.5 U dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent&#xD;
&#xD;
          2. Males or females ≥ 18 years old&#xD;
&#xD;
          3. Anterior gingival exposure during smiling larger than 4 mm measured from the central&#xD;
             incisor tooth (part A), or 2-4 mm (part B).&#xD;
&#xD;
          4. Subjects of childbearing potential who present a negative urine pregnancy test at&#xD;
             baseline and use an effective contraceptive method.&#xD;
&#xD;
          5. Subjects are in good health as judged by the investigator.&#xD;
&#xD;
          6. Subjects who are willing and have the ability to understand and provide informed&#xD;
             consent for participation in the study and are able to communicate with the&#xD;
             investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant women or women intending to become pregnant in the next 8 months after the&#xD;
             screening for eligibility&#xD;
&#xD;
          2. Subjects participating in other clinical trials&#xD;
&#xD;
          3. Any prior surgery affecting the area of study&#xD;
&#xD;
          4. Subjects with neoplastic, muscular or neurological disease&#xD;
&#xD;
          5. Subjects who have received botulinum toxin treatment for gummy smile in the previous&#xD;
             12 months before the inclusion date&#xD;
&#xD;
          6. Subjects who have received Botulinum toxin treatment for any other cosmetic indication&#xD;
             in the previous 6 months before the inclusion date&#xD;
&#xD;
          7. Subjects using aminoglycosides and penicillamine antibiotics, quinine or calcium&#xD;
             channel blockers&#xD;
&#xD;
          8. Subjects with inflammation or active infection in the area to be injected&#xD;
&#xD;
          9. Subjects with history of sensitivity to the components of the formulation.&#xD;
&#xD;
         10. Uncooperative patients or patients with neurological disorders who are incapable of&#xD;
             following directions or who are predictably unwilling to return for follow-up&#xD;
             examinations.&#xD;
&#xD;
         11. Subjects who are unable to understand the protocol or give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Murad Alam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University Department of Dermatology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>December 2, 2021</last_update_submitted>
  <last_update_submitted_qc>December 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Murad Alam</investigator_full_name>
    <investigator_title>Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03284047
org study id: STU00205065
nct id: NCT03284047
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a two part study to measure and observe the efficacy of botulinum toxin A for the
      treatment of gummy smiles.

      Part A will randomly compare three different doses of botulinum toxin type A
      (abobotulinumtoxin A) for the treatment of upper anterior gummy smile with larger gingival
      exposure (> 4 mm).

      Part B will assign one of two doses of botulinum toxin type A for participants with smaller
      gingival exposure (< 4 mm).

      Follow-up visits with photography will occur 4 and 12 weeks after their treatment. Subjects
      currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will
      be considered for enrollment.

      This study is a pilot study designed to determine feasibility of this procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Reduction of the upper gum exposure at 4 weeks and 12 weeks.
time frame: [Baseline, 4 weeks,12 weeks]
description: Reduction in millimeters in the upper gum exposure of subjects after botulinum toxin type A (abobotulinumtoxin A) treatment.
arm group label: 2.5 U dose
arm group type: Experimental
description: Participants with more than 4 mm of upper anterior gingival exposure measured from the central incisor tooth will be randomly assigned (1:1:1) to receive different doses of botulinum toxin type A (abobotulinumtoxin A) on the levator labii superioris alaeque nasi as follows:
2.5 U
5 U
7.5 U
arm group label: 5 U dose
arm group type: Experimental
description: Participants with more than 4 mm of upper anterior gingival exposure measured from the central incisor tooth will be randomly assigned (1:1:1) to receive different doses of botulinum toxin type A (abobotulinumtoxin A) on the levator labii superioris alaeque nasi as follows:
2.5 U
5 U
7.5 U
arm group label: 7.5 U dose
arm group type: Experimental
description: Participants with more than 4 mm of upper anterior gingival exposure measured from the central incisor tooth will be randomly assigned (1:1:1) to receive different doses of botulinum toxin type A (abobotulinumtoxin A) on the levator labii superioris alaeque nasi as follows:
2.5 U
5 U
7.5 U
intervention type: Drug
intervention name: Botulinum toxin type A
description: Participants will be randomized to one of three botulinum toxin type A doses.
arm group label: 2.5 U dose
arm group label: 5 U dose
arm group label: 7.5 U dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Murad Alam, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Murad Alam
investigator title: Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
sharing ipd: No