<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/NCT04486794</url>
  </required_header>
  <id_info>
    <org_study_id>2020-Res-TT</org_study_id>
    <nct_id>NCT04486794</nct_id>
  </id_info>
  <brief_title>Restylane® for the Treatment of Tear Trough Deformity</brief_title>
  <official_title>A Clinical Evaluation of the Efficacy and Safety of Hyaluronic Acid (Restylane®) for the Treatment of Tear Trough Deformity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erevna Innovations Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erevna Innovations Inc.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the effectiveness and tolerability of Restylane® for&#xD;
      correction of tear trough deformity, using various injection techniques.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 7, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 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>Crossover Assignment</intervention_model>
    <intervention_model_description>Patients in this current trial will initially be randomized to either needle or cannula injections, or no treatment (control; ratio 3:3:1, respectively). Subjects will proceed from randomization in parallel assignment. Subjects initially randomized to the control group at Baseline will be randomized to either needle or cannula treatment at Visit 3, Month 1 (crossover). Subjects in the crossover group will then be seen at weeks 2 and 4 post last treatment, as per Schedule 1.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>GAIS</measure>
    <time_frame>1 month</time_frame>
    <description>Improvement via the blinded evaluator-assessed Global Aesthetic Improvement Scale (GAIS), at the one-month follow up visit. Improvement will be considered as any point-increase above 0 (no change).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Baseline to end of study (up to week 10)</time_frame>
    <description>Safety measurements will be evaluated by the incidence, seriousness, severity and relationship with the medical device to adverse events reported, at all visits.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Tear Trough Eyelid Deformity</condition>
  <arm_group>
    <arm_group_label>Treatment at baseline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment at Month 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Restylane®</intervention_name>
    <description>Hyaluronic acid</description>
    <arm_group_label>Treatment at Month 1</arm_group_label>
    <arm_group_label>Treatment at baseline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female;&#xD;
&#xD;
          2. Age of 18 years or greater;&#xD;
&#xD;
          3. Indication for treatment of bilateral tear trough deformity;&#xD;
&#xD;
          4. Symmetry of tear trough deformity at baseline;&#xD;
&#xD;
          5. Subjects who understood and signed the Informed Consent Form (ICF) when entering the&#xD;
             study, before performing any investigational procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior (&lt;1 year) or planning to undergo any surgery in the corporal area of interest&#xD;
             for study;&#xD;
&#xD;
          2. Any type of comorbidity or clinical condition that, at investigator's discretion,&#xD;
             could interfere with study assessments;&#xD;
&#xD;
          3. Diabetes mellitus type 1 or type 2;&#xD;
&#xD;
          4. Autoimmune diseases, collagenosis, decompensated endocrine diseases or any disease&#xD;
             that, at investigator's discretion, could interfere with study assessments;&#xD;
&#xD;
          5. Using or have used within 3 months drugs such as corticosteroids, immunosuppressants&#xD;
             or others collagen-production inhibitors;&#xD;
&#xD;
          6. Initiated use of hormones or change in dose of hormonal replacement therapy within 3&#xD;
             months;&#xD;
&#xD;
          7. Pregnant or breastfeeding, or wishes to get pregnant within the next 12 months, or&#xD;
             refuses to use appropriate contraceptive method (in case of women of childbearing&#xD;
             potential);&#xD;
&#xD;
          8. Restylane® should not be used in any person who has hypersensitivity to any of the&#xD;
             components of the product;&#xD;
&#xD;
          9. Active skin inflammation or infection in or near the treatment area;&#xD;
&#xD;
         10. Possessing any of the contraindications for use of Restylane®;&#xD;
&#xD;
         11. Septal fat herniation;&#xD;
&#xD;
         12. Severe elastosis (e.g., dermatochalasis);&#xD;
&#xD;
         13. Use of Vitamin E, gingko biloba, Aspirin or non-steroidal anti-inflammatory drugs&#xD;
             (NSAIDS) within 1 week of treatment.&#xD;
&#xD;
         14. Use of tear trough injections in the last 12 months.&#xD;
&#xD;
         15. Use of anterior midface injections in the last 12 months.&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Andreas Nikolis, FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erevna Innovations Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Erevna Innovations Inc</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3R 3A1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>February 7, 2021</last_update_submitted>
  <last_update_submitted_qc>February 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_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/NCT04486794
org study id: 2020-Res-TT
nct id: NCT04486794
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the effectiveness and tolerability of Restylane® for
      correction of tear trough deformity, using various injection techniques.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Patients in this current trial will initially be randomized to either needle or cannula injections, or no treatment (control; ratio 3:3:1, respectively). Subjects will proceed from randomization in parallel assignment. Subjects initially randomized to the control group at Baseline will be randomized to either needle or cannula treatment at Visit 3, Month 1 (crossover). Subjects in the crossover group will then be seen at weeks 2 and 4 post last treatment, as per Schedule 1.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: GAIS
time frame: 1 month
description: Improvement via the blinded evaluator-assessed Global Aesthetic Improvement Scale (GAIS), at the one-month follow up visit. Improvement will be considered as any point-increase above 0 (no change).
measure: Adverse events
time frame: Baseline to end of study (up to week 10)
description: Safety measurements will be evaluated by the incidence, seriousness, severity and relationship with the medical device to adverse events reported, at all visits.
arm group label: Treatment at baseline
arm group type: Experimental
arm group label: Treatment at Month 1
arm group type: Active Comparator
intervention type: Device
intervention name: Restylane®
description: Hyaluronic acid
arm group label: Treatment at Month 1
arm group label: Treatment at baseline
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andreas Nikolis, FRCSC
role: Principal Investigator
affiliation: Erevna Innovations Inc.
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Congenital Abnormalities
sharing ipd: No