<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/NCT03816046</url>
  </required_header>
  <id_info>
    <org_study_id>usj-05</org_study_id>
    <nct_id>NCT03816046</nct_id>
  </id_info>
  <brief_title>Hyperhydrosis Treatment Using Botulinum Toxin</brief_title>
  <official_title>The Quadrant vs the Six Injection Technique in Primary Focal Hyperhidrosis Using Botulinum Toxin: a Cross-over Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St Joseph University, Beirut, Lebanon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St Joseph University, Beirut, Lebanon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to describe two safe and reproducible techniques for the&#xD;
      treatment of hyperhidrosis using botulinum toxin. The same patient will receive two different&#xD;
      injection technique in each armpit and will be evaluated subjectively and objectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The abobotulinumtoxinA (ABO) will be used in all patients. The ABO will be prepared by adding&#xD;
      4 cc of normal saline to a 500-unit Dysport© (Ipsen Ltd, Berks, UK) vial Preinjection patient&#xD;
      pictures will be taken showing the technique used for each armpit.&#xD;
&#xD;
      Injection technique:&#xD;
&#xD;
        1. Technique 1 The Quadrant technique: 5 vertical lines and 5 horizontal lines will be draw&#xD;
           on the hair bearing area of the armpit amounting to 25 injection points being more&#xD;
           concentrated on the center. Each injection consists of 5Units of abobotulinum&#xD;
&#xD;
        2. Technique 2 the six injection technique: will consist on 6 injections in the hair&#xD;
           bearing area equally spaced with each consisting of 8units&#xD;
&#xD;
      Follow up will be done at 15 days for post injection pictures with iodine starch test A total&#xD;
      of 15 male patients will be recruited. And the injection for each armpit in a given patient&#xD;
      is randomized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</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>Crossover Assignment</intervention_model>
    <intervention_model_description>describe two safe and reproducible techniques for the treatment of hyperhidrosis using botulinum toxin. The same patient will receive two different injection technique in each armpit and will be evaluated subjectively and objectively.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>the objective assessment with iodine starch test</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>objective iodine startch</measure>
    <time_frame>3weeks</time_frame>
    <description>Objective assessment will be done using the iodine starch after a 5 min jumping jack on the post injection visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>subjective: patient satisfaction</measure>
    <time_frame>3 weeks</time_frame>
    <description>Patient satisfaction will be determined by a questionnaire completed at 3 weeks post-treatment. Subjects will indicate how satisfied they are on a 4-point scale (1-4) as follow:&#xD;
Very Satisfied&#xD;
Satisfied&#xD;
Dissatisfied&#xD;
Very Dissatisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>subjective: pain on injection</measure>
    <time_frame>day 0</time_frame>
    <description>A verbal scale from 1-10 will be addressed for every patient and every armpit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Hyperhidrosis</condition>
  <arm_group>
    <arm_group_label>Technique 1 The Quadrant technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: 25 Botulinum Toxin injections. 5 vertical lines and 5 horizontal lines will be draw on the hair bearing area of the armpit amounting to 25 injection points being more concentrated on the center. Each injection consists of 5Units of abobotulinum</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Technique 2 the six injection technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: 6 Botulinum Toxin injections. will consist on 6 injections in the hair bearing area equally spaced with each consisting of 8units</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>botulinum toxin A</intervention_name>
    <description>injection in hair bearing area of armpits</description>
    <arm_group_label>Technique 1 The Quadrant technique</arm_group_label>
    <arm_group_label>Technique 2 the six injection technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Consecutive 15 male patients presenting to our clinic for primary localized hyperhidrosis&#xD;
        will be included in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient that has received a botulinum injection in the past year&#xD;
&#xD;
        Patient that had a liposuction in the armpit or laser for the hair&#xD;
&#xD;
        Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert&#xD;
        syndrome) Patients using medication that could potentiate the effect of botulinum (ex:&#xD;
        aminoglycoside antibiotics) Patients with sensitivity to botulinum toxin or human albumin&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hotel Dieu de France</name>
      <address>
        <city>Beirut</city>
        <zip>0000</zip>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>June 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 20, 2019</last_update_submitted>
  <last_update_submitted_qc>January 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St Joseph University, Beirut, Lebanon</investigator_affiliation>
    <investigator_full_name>samer jabbour</investigator_full_name>
    <investigator_title>M.D</investigator_title>
  </responsible_party>
  <keyword>botulinum toxim</keyword>
  <keyword>abobotulinum</keyword>
  <keyword>hyperhydrosis</keyword>
  <keyword>injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperhidrosis</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>
  <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/NCT03816046
org study id: usj-05
nct id: NCT03816046
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The purpose of this study is to describe two safe and reproducible techniques for the
      treatment of hyperhidrosis using botulinum toxin. The same patient will receive two different
      injection technique in each armpit and will be evaluated subjectively and objectively.
The abobotulinumtoxinA (ABO) will be used in all patients. The ABO will be prepared by adding
      4 cc of normal saline to a 500-unit Dysport© (Ipsen Ltd, Berks, UK) vial Preinjection patient
      pictures will be taken showing the technique used for each armpit.

      Injection technique:

        1. Technique 1 The Quadrant technique: 5 vertical lines and 5 horizontal lines will be draw
           on the hair bearing area of the armpit amounting to 25 injection points being more
           concentrated on the center. Each injection consists of 5Units of abobotulinum

        2. Technique 2 the six injection technique: will consist on 6 injections in the hair
           bearing area equally spaced with each consisting of 8units

      Follow up will be done at 15 days for post injection pictures with iodine starch test A total
      of 15 male patients will be recruited. And the injection for each armpit in a given patient
      is randomized.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: describe two safe and reproducible techniques for the treatment of hyperhidrosis using botulinum toxin. The same patient will receive two different injection technique in each armpit and will be evaluated subjectively and objectively.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: the objective assessment with iodine starch test
measure: objective iodine startch
time frame: 3weeks
description: Objective assessment will be done using the iodine starch after a 5 min jumping jack on the post injection visit.
measure: subjective: patient satisfaction
time frame: 3 weeks
description: Patient satisfaction will be determined by a questionnaire completed at 3 weeks post-treatment. Subjects will indicate how satisfied they are on a 4-point scale (1-4) as follow:
Very Satisfied
Satisfied
Dissatisfied
Very Dissatisfied.
measure: subjective: pain on injection
time frame: day 0
description: A verbal scale from 1-10 will be addressed for every patient and every armpit
arm group label: Technique 1 The Quadrant technique
arm group type: Experimental
description: Intervention: 25 Botulinum Toxin injections. 5 vertical lines and 5 horizontal lines will be draw on the hair bearing area of the armpit amounting to 25 injection points being more concentrated on the center. Each injection consists of 5Units of abobotulinum
arm group label: Technique 2 the six injection technique
arm group type: Experimental
description: Intervention: 6 Botulinum Toxin injections. will consist on 6 injections in the hair bearing area equally spaced with each consisting of 8units
intervention type: Drug
intervention name: botulinum toxin A
description: injection in hair bearing area of armpits
arm group label: Technique 1 The Quadrant technique
arm group label: Technique 2 the six injection technique
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Lebanon
responsible party type: Principal Investigator
investigator affiliation: St Joseph University, Beirut, Lebanon
investigator full name: samer jabbour
investigator title: M.D
mesh term: Hyperhidrosis
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
sharing ipd: No