<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/NCT02216838</url>
  </required_header>
  <id_info>
    <org_study_id>STU97514</org_study_id>
    <nct_id>NCT02216838</nct_id>
  </id_info>
  <brief_title>Treatment of Facial Flushing With Botulinum Toxin A Injections</brief_title>
  <official_title>Treatment of Facial Flushing With Botulinum Toxin A Injections: A Split-Face, Double-blinded, Randomized Control Trial</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out if botulinum toxin A (botox®) can be used to treat&#xD;
      facial flushing.&#xD;
&#xD;
      This study is a pilot study designed to determine feasibility of these procedures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Spectrophotometer measurement</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Facial Flushing</condition>
  <arm_group>
    <arm_group_label>botulinum toxin A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This study is randomized, which means the subject will be randomly assigned (like a flip of a coin) to receive botox on the right or left side of the face and saline injections on the other side. Only one side of the face will receive botox injections.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This study is randomized, which means the subject will be randomly assigned (like a flip of a coin) to receive botox on the right or left side of the face and saline injections on the other side. Only one side of the face will receive botox injections.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>botulinum toxin A</intervention_name>
    <description>A total of 10U will be injected at 1cm increments by the blinded dermatologist into the respective randomized side.</description>
    <arm_group_label>botulinum toxin A</arm_group_label>
    <other_name>Botox</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline Control</intervention_name>
    <description>A total of 0.5cc benzyl alcohol containing saline will be injected at 1cm increments by the blinded dermatologist into the respective randomized side</description>
    <arm_group_label>Saline Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients 18-65 years of age with persistent facial flushing&#xD;
&#xD;
          2. Willing and have the ability to understand and provide informed consent for&#xD;
             participation in the study and are able to communicate with the study staff.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable to understand the protocol or give informed consent&#xD;
&#xD;
          2. Younger than 18 or older than 65 years of age&#xD;
&#xD;
          3. Females who are pregnant or lactating&#xD;
&#xD;
          4. Known hypersensitivity to BTX-A&#xD;
&#xD;
          5. Subjects using medications that interfere with neuromuscular functions (such as&#xD;
             aminoglycoside antibiotics)&#xD;
&#xD;
          6. Subjects who have a history of congestive heart failure, carcinoid syndrome,&#xD;
             mastocystosis, or renal cell carcinoma&#xD;
&#xD;
          7. Botulinum toxin injections in the past 6 months&#xD;
&#xD;
          8. Ablative laser procedure in the past 6 months&#xD;
&#xD;
          9. Radiofrequency device treatment in the past 6 months&#xD;
&#xD;
         10. Ultrasound device treatment in the past 6 months&#xD;
&#xD;
         11. Medium to deep chemical peel in the past 6 months&#xD;
&#xD;
         12. Temporary soft tissue augmentation material in the area to be treated in the past year&#xD;
&#xD;
         13. Semi-permanent soft tissue augmentation material in the area to be treated in the past&#xD;
             2 years&#xD;
&#xD;
         14. Permanent soft tissue augmentation material in the area to be treated&#xD;
&#xD;
         15. Is planning to receive within the next 6 months, any cosmetic procedure (such as any&#xD;
             chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures,&#xD;
             filler injections, radiofrequency procedures, dermabrasion, ultrasound and face&#xD;
             lifting procedures) in the forehead or glabellar region.&#xD;
&#xD;
         16. Is planning to use tretinoin or retinoic acid in the next 6 months&#xD;
&#xD;
         17. Has an active infection in the forehead or glabellar region (excluding mild acne)&#xD;
&#xD;
         18. Is allergic to cow's milk protein&#xD;
&#xD;
         19. Is allergic to albumin&#xD;
&#xD;
         20. Is currently using anticoagulation therapy&#xD;
&#xD;
         21. Has a history of bleeding disorders&#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>Murad Alam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine, 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>February 2023</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>February 17, 2023</last_update_submitted>
  <last_update_submitted_qc>February 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Facies</mesh_term>
    <mesh_term>Flushing</mesh_term>
  </condition_browse>
  <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>
  <!-- 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/NCT02216838
org study id: STU97514
nct id: NCT02216838
lead sponsor: 
has dmc: Yes
The purpose of this study is to find out if botulinum toxin A (botox®) can be used to treat
      facial flushing.

      This study is a pilot study designed to determine feasibility of these procedures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Spectrophotometer measurement
time frame: Baseline and 8 weeks
description: Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit
arm group label: botulinum toxin A
arm group type: Experimental
description: This study is randomized, which means the subject will be randomly assigned (like a flip of a coin) to receive botox on the right or left side of the face and saline injections on the other side. Only one side of the face will receive botox injections.
arm group label: Saline Control
arm group type: Placebo Comparator
description: This study is randomized, which means the subject will be randomly assigned (like a flip of a coin) to receive botox on the right or left side of the face and saline injections on the other side. Only one side of the face will receive botox injections.
intervention type: Drug
intervention name: botulinum toxin A
description: A total of 10U will be injected at 1cm increments by the blinded dermatologist into the respective randomized side.
arm group label: botulinum toxin A
other name: Botox
intervention type: Other
intervention name: Saline Control
description: A total of 0.5cc benzyl alcohol containing saline will be injected at 1cm increments by the blinded dermatologist into the respective randomized side
arm group label: Saline Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
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: Facies
mesh term: Flushing
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA