<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/NCT03836638</url>
  </required_header>
  <id_info>
    <org_study_id>USJ-09</org_study_id>
    <nct_id>NCT03836638</nct_id>
  </id_info>
  <brief_title>The Impact of Age on Botulinum Toxin Potency in Facial Rhytides Treatment</brief_title>
  <official_title>The Impact of Age on Botulinum Toxin Potency in Facial Rhytides Treatment: A Prospective Randomized Controlled 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Botulinum toxin is approved by the FDA for the treatment of facial wrinkles. Patients are&#xD;
      usually older than 45 years and their main demand is to treat pre-existing facial wrinkles.&#xD;
      However with the increasing popularity of this technique, younger patients, aged 25 to 35&#xD;
      years, are now seeking botulinum toxin injection as a preventive measure for rhytides. The&#xD;
      usual dose used for the treatment of facial rhytides in a female patient older than 45 years&#xD;
      is 50 units. No consensus exists concerning the dose of botulinum toxin that should be used&#xD;
      in younger patients. Hypothesis: lower dose of botulinum toxin is sufficient to give good and&#xD;
      long lasting results in young patients. The objective of this randomized open-label study is&#xD;
      to evaluate the effect of lower doses of Botulinum toxin on the facial rythides in young&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Botulinum toxin is approved by the FDA for the treatment of facial wrinkles. Patients are&#xD;
      usually older than 45 years and their main demand is to treat pre-existing facial wrinkles.&#xD;
      However with the increasing popularity of this technique, younger patients, aged 25 to 35&#xD;
      years, are now seeking botulinum toxin injection as a preventive measure for rhytides. The&#xD;
      usual dose used for the treatment of facial rhytides in a female patient older than 45 years&#xD;
      is 50 units. No consensus exists concerning the dose of botulinum toxin that should be used&#xD;
      in younger patients. Hypothesis: lower dose of botulinum toxin is sufficient to give good and&#xD;
      long lasting results in young patients.&#xD;
&#xD;
      The objective of this randomized open-label study is to evaluate the effect of lower doses of&#xD;
      Botulinum toxin on the facial rythides in young patients.&#xD;
&#xD;
      In this trial, patients will be divided into 3 groups: Group 1 patients will be 25-35 years&#xD;
      old and will be injected with 30 units of botulinum toxin into the upper face, group 2&#xD;
      patients will be older than 45 and will be injected with the same amount of botulinum toxin&#xD;
      into the upper face and group 3 patients will be older than 45 and will be treated with the&#xD;
      usual 50 units dose (control group). Patients older than 45 will be randomized between groups&#xD;
      2 and 3. Validated photonumeric scales will be used to evaluate the wrinkles at rest and with&#xD;
      muscle contraction at 2, 4, 8, 12, 16, 20, 24 weeks post injection in the 3 groups. The&#xD;
      patient satisfaction rate and the Physician global assessment will also be evaluated in the 3&#xD;
      groups. The scores will be determined by 3 independent blinded raters.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      (1) the low dose will be sufficient to treat the group 1 patients and it will be insufficient&#xD;
      to treat the group 2 patients. (2) The results will last longer in groups 1 and 3 patients&#xD;
      compared to group 2 patients. (3) Group 1 patients treated with low doses of botulinum toxin&#xD;
      will have similar results to the group 3 patients treated with the standard dose of botulinum&#xD;
      toxin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 1, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2020</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>Changes of scores of Validated photonumeric scales: Brow Positioning Scale at rest</measure>
    <time_frame>0, 2, 4, 8, 12, 16, 20, 24 weeks</time_frame>
    <description>0-Youthful, refreshed look and high-arch eyebrow&#xD;
Medium-arch eyebrow&#xD;
Slight arch of the eyebrow&#xD;
Flat arch of the eyebrow, visibility of folds, and tired appearance&#xD;
Flat eyebrow with barely any arch, marked visibility of folds, and very tired appearance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of scores of Validated photonumeric scales: Forehead Lines Scale at rest</measure>
    <time_frame>0, 2, 4, 8, 12, 16, 20, 24 weeks</time_frame>
    <description>0-None&#xD;
Minimal&#xD;
Moderate&#xD;
Deep&#xD;
Extreme</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of scores of Validated photonumeric scales: Forehead Lines Scale with contraction</measure>
    <time_frame>0, 2, 4, 8, 12, 16, 20, 24 weeks</time_frame>
    <description>0-None&#xD;
Minimal&#xD;
Moderate&#xD;
Deep&#xD;
Extreme</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of scores of Validated photonumeric scales: Glabellar Lines Scale at rest</measure>
    <time_frame>0, 2, 4, 8, 12, 16, 20, 24 weeks</time_frame>
    <description>0-No glabella lines&#xD;
Mild glabella lines&#xD;
Moderate glabella lines&#xD;
Severe glabella lines&#xD;
Very severe glabella lines</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of scores of Validated photonumeric scales: Glabellar Lines Scale with contraction</measure>
    <time_frame>0, 2, 4, 8, 12, 16, 20, 24 weeks</time_frame>
    <description>0-No glabella lines&#xD;
Mild glabella lines&#xD;
Moderate glabella lines&#xD;
Severe glabella lines&#xD;
Very severe glabella lines</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of scores of Validated photonumeric scales: Crow Feet Scale at rest</measure>
    <time_frame>0, 2, 4, 8, 12, 16, 20, 24 weeks</time_frame>
    <description>0-No wrinkles&#xD;
Mild wrinkles&#xD;
Moderate wrinkles&#xD;
Severe wrinkles&#xD;
Very severe wrinkles</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of scores of Validated photonumeric scales: Crow Feet Scale with contraction</measure>
    <time_frame>0, 2, 4, 8, 12, 16, 20, 24 weeks</time_frame>
    <description>0-No wrinkles&#xD;
Mild wrinkles&#xD;
Moderate wrinkles&#xD;
Severe wrinkles&#xD;
Very severe wrinkles</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigators Global Aesthetic Improvement Scale</measure>
    <time_frame>0, 2, 4, 8, 12, 16, 20, 24 weeks</time_frame>
    <description>Very Much Improved: optimal cosmetic results&#xD;
Much Improved: marked improvement in appearance from initial condition but not completely optimal&#xD;
Improved: obvious improvement in appearance from initial condition but additional treatments are advised&#xD;
No Change: the appearance is the same as the original condition&#xD;
Worse: the appearance is worse from the original condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>0, 2, 4, 8, 12, 16, 20, 24 weeks</time_frame>
    <description>Very Satisfied&#xD;
Satisfied&#xD;
Dissatisfied&#xD;
Very Dissatisfied.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Aging</condition>
  <condition>Botulinum Toxin</condition>
  <condition>Facial Wrinkles</condition>
  <arm_group>
    <arm_group_label>Low dose young subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1 patients will be 25-35 years old and will be injected with 30 units of botulinum toxin into the upper face</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose older subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 2 patients will be older than 45 and will be injected with 30 units of botulinum toxin into the upper face</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high dose older subjects</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 3 patients will be older than 45 and will be treated with the usual 50 units dose into the upper face (control group)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>30 Units of botulinum toxin</intervention_name>
    <description>30 Units of botulinum toxin to upper face</description>
    <arm_group_label>Low dose older subjects</arm_group_label>
    <arm_group_label>Low dose young subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>50 Units of botulinum toxin</intervention_name>
    <description>50 Units of botulinum toxin to upper face</description>
    <arm_group_label>high dose older subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female patients presenting to our clinic for Facial wrinkle treatment with botulinum&#xD;
             toxin&#xD;
&#xD;
          -  Must be between 25-35 years old to be included in group 1.&#xD;
&#xD;
          -  Must be older than 45 to be included in groups 2 and 3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous periorbital/forehead surgery&#xD;
&#xD;
          -  Patients who plucked the upper eyebrow margin&#xD;
&#xD;
          -  Patients with eyebrow tatoos&#xD;
&#xD;
          -  Patients with upper face botulinum toxin injection in the past 12 months&#xD;
&#xD;
          -  Patients with resorbable upper face fillers injection in the past 12 months&#xD;
&#xD;
          -  Patients with previous permanent upper face fillers injection&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Lactating patients&#xD;
&#xD;
          -  Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert&#xD;
             syndrome)&#xD;
&#xD;
          -  Patients using medication that could potentiate the effect of botulinum (ex:&#xD;
             aminoglycoside antibiotics)&#xD;
&#xD;
          -  Patients with sensitivity to botulinum toxin or human albumin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hotel Dieu De France</name>
      <address>
        <city>Beirut</city>
        <state>Aschrafieh</state>
        <zip>00961</zip>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 24, 2018</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 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>Resident</investigator_title>
  </responsible_party>
  <keyword>Botulinum Toxin</keyword>
  <keyword>Rejuvenation</keyword>
  <keyword>Age</keyword>
  <keyword>Wrinkles</keyword>
  <keyword>Rhytidis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Facies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</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/NCT03836638
org study id: USJ-09
nct id: NCT03836638
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Botulinum toxin is approved by the FDA for the treatment of facial wrinkles. Patients are
      usually older than 45 years and their main demand is to treat pre-existing facial wrinkles.
      However with the increasing popularity of this technique, younger patients, aged 25 to 35
      years, are now seeking botulinum toxin injection as a preventive measure for rhytides. The
      usual dose used for the treatment of facial rhytides in a female patient older than 45 years
      is 50 units. No consensus exists concerning the dose of botulinum toxin that should be used
      in younger patients. Hypothesis: lower dose of botulinum toxin is sufficient to give good and
      long lasting results in young patients. The objective of this randomized open-label study is
      to evaluate the effect of lower doses of Botulinum toxin on the facial rythides in young
      patients.
Botulinum toxin is approved by the FDA for the treatment of facial wrinkles. Patients are
      usually older than 45 years and their main demand is to treat pre-existing facial wrinkles.
      However with the increasing popularity of this technique, younger patients, aged 25 to 35
      years, are now seeking botulinum toxin injection as a preventive measure for rhytides. The
      usual dose used for the treatment of facial rhytides in a female patient older than 45 years
      is 50 units. No consensus exists concerning the dose of botulinum toxin that should be used
      in younger patients. Hypothesis: lower dose of botulinum toxin is sufficient to give good and
      long lasting results in young patients.

      The objective of this randomized open-label study is to evaluate the effect of lower doses of
      Botulinum toxin on the facial rythides in young patients.

      In this trial, patients will be divided into 3 groups: Group 1 patients will be 25-35 years
      old and will be injected with 30 units of botulinum toxin into the upper face, group 2
      patients will be older than 45 and will be injected with the same amount of botulinum toxin
      into the upper face and group 3 patients will be older than 45 and will be treated with the
      usual 50 units dose (control group). Patients older than 45 will be randomized between groups
      2 and 3. Validated photonumeric scales will be used to evaluate the wrinkles at rest and with
      muscle contraction at 2, 4, 8, 12, 16, 20, 24 weeks post injection in the 3 groups. The
      patient satisfaction rate and the Physician global assessment will also be evaluated in the 3
      groups. The scores will be determined by 3 independent blinded raters.

      Hypothesis:

      (1) the low dose will be sufficient to treat the group 1 patients and it will be insufficient
      to treat the group 2 patients. (2) The results will last longer in groups 1 and 3 patients
      compared to group 2 patients. (3) Group 1 patients treated with low doses of botulinum toxin
      will have similar results to the group 3 patients treated with the standard dose of botulinum
      toxin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes of scores of Validated photonumeric scales: Brow Positioning Scale at rest
time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
description: 0-Youthful, refreshed look and high-arch eyebrow
Medium-arch eyebrow
Slight arch of the eyebrow
Flat arch of the eyebrow, visibility of folds, and tired appearance
Flat eyebrow with barely any arch, marked visibility of folds, and very tired appearance.
measure: Changes of scores of Validated photonumeric scales: Forehead Lines Scale at rest
time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
description: 0-None
Minimal
Moderate
Deep
Extreme
measure: Changes of scores of Validated photonumeric scales: Forehead Lines Scale with contraction
time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
description: 0-None
Minimal
Moderate
Deep
Extreme
measure: Changes of scores of Validated photonumeric scales: Glabellar Lines Scale at rest
time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
description: 0-No glabella lines
Mild glabella lines
Moderate glabella lines
Severe glabella lines
Very severe glabella lines
measure: Changes of scores of Validated photonumeric scales: Glabellar Lines Scale with contraction
time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
description: 0-No glabella lines
Mild glabella lines
Moderate glabella lines
Severe glabella lines
Very severe glabella lines
measure: Changes of scores of Validated photonumeric scales: Crow Feet Scale at rest
time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
description: 0-No wrinkles
Mild wrinkles
Moderate wrinkles
Severe wrinkles
Very severe wrinkles
measure: Changes of scores of Validated photonumeric scales: Crow Feet Scale with contraction
time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
description: 0-No wrinkles
Mild wrinkles
Moderate wrinkles
Severe wrinkles
Very severe wrinkles
measure: Investigators Global Aesthetic Improvement Scale
time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
description: Very Much Improved: optimal cosmetic results
Much Improved: marked improvement in appearance from initial condition but not completely optimal
Improved: obvious improvement in appearance from initial condition but additional treatments are advised
No Change: the appearance is the same as the original condition
Worse: the appearance is worse from the original condition
measure: Patient satisfaction
time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
description: Very Satisfied
Satisfied
Dissatisfied
Very Dissatisfied.
arm group label: Low dose young subjects
arm group type: Experimental
description: Group 1 patients will be 25-35 years old and will be injected with 30 units of botulinum toxin into the upper face
arm group label: Low dose older subjects
arm group type: Experimental
description: Group 2 patients will be older than 45 and will be injected with 30 units of botulinum toxin into the upper face
arm group label: high dose older subjects
arm group type: Active Comparator
description: Group 3 patients will be older than 45 and will be treated with the usual 50 units dose into the upper face (control group)
intervention type: Drug
intervention name: 30 Units of botulinum toxin
description: 30 Units of botulinum toxin to upper face
arm group label: Low dose older subjects
arm group label: Low dose young subjects
intervention type: Drug
intervention name: 50 Units of botulinum toxin
description: 50 Units of botulinum toxin to upper face
arm group label: high dose older subjects
criteria: 
gender: All
minimum age: 25 Years
maximum age: N/A
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: Resident
mesh term: Facies
mesh term: Botulinum Toxins
sharing ipd: No