<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/NCT04488939</url>
  </required_header>
  <id_info>
    <org_study_id>2020-Gal-SBV</org_study_id>
    <nct_id>NCT04488939</nct_id>
  </id_info>
  <brief_title>Restylane® Skinboosters™ Vital in the décolletage Region</brief_title>
  <official_title>A Prospective, Open-label Evaluation of Restylane® Skinboosters™ Vital in the décolletage Region</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>
      Restylane® Skinboosters™ Vital (SBV) is a smooth formulation without particles, which helps&#xD;
      it distribute evenly and smoothly under the skin to aid in rejuvenation. This feature makes&#xD;
      RSV particularly well suited for more superficial injections, such as at the level of the&#xD;
      dermis.&#xD;
&#xD;
      SBV smooths fine lines and wrinkles and is intended to improve skin smoothness and&#xD;
      appearance, as well as the elasticity and hydration of the skin in the face and dorsal hands.&#xD;
      However, many clinicians have used SBV in other regions of the body. Given these attributes,&#xD;
      SBV are particularly well suited for photo aged skin. A region that is susceptible to&#xD;
      photo-ageing and may therefore benefit from the use of SBV is the décolletage. Photodamaged&#xD;
      skin of the chest is characterized by atrophy, skin laxity, fine lines and wrinkles,&#xD;
      dehydration and tactile roughness. Therefore, SBV may help to improve these signs of aging in&#xD;
      the décolletage region.&#xD;
&#xD;
      Study Aim: To investigate the effectiveness and tolerability of SBV for rejuvenation of the&#xD;
      décolletage region.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Galderma Décolletage Scale</measure>
    <time_frame>Visit 4, Week 12</time_frame>
    <description>Proportion of subjects achieving at least a one-point improvement on the Galderma Décolletage Scale (GDS), one month following the treatment regime (i.e., Visit 4; Week 12; one month after completing three treatments, each spaced one month apart). Scores: 0 (none) to 4 (severe)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Galderma Décolletage Scale</measure>
    <time_frame>Visit 5 and 6 (Weeks 16 and 20)</time_frame>
    <description>Proportion of subjects achieving at least a one-point improvement on the Galderma Décolletage Scale , at Visits 5 and 6 (i.e., 2- and 3-months post treatment regime). Scores: 0 (non) to 4 (severe)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Decolletage Rejuvenation</condition>
  <arm_group>
    <arm_group_label>Bilateral treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Restylane® Skinboosters™ Vital (SBV)</intervention_name>
    <description>Hyaluronic acid</description>
    <arm_group_label>Bilateral treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A score &gt; 2 on the GDS, as assessed by the treating physician at Baseline.&#xD;
&#xD;
          2. Females aged &gt; 25 and &lt; 70&#xD;
&#xD;
          3. Ability to adequately understand the verbal explanations and the written subject&#xD;
             information provided in local language and ability and willingness to give consent to&#xD;
             participate in the study.&#xD;
&#xD;
          4. Signed and dated informed consent to participate in the study and unrestricted use of&#xD;
             décolletage images for marketing purpose.&#xD;
&#xD;
          5. If female of childbearing potential: a negative urine pregnancy test before all&#xD;
             treatments is required.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current Pregnancy or lactation [sexually active women of childbearing age must agree&#xD;
             to use medically acceptable methods of contraception for the duration of this study&#xD;
             (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];&#xD;
&#xD;
          2. Patients meeting any official Restylane contra-indications;&#xD;
&#xD;
          3. Inability to comply with follow-up and abstain from other treatments in the region of&#xD;
             interest during the study period;&#xD;
&#xD;
          4. Heavy smokers, classified as smoking more than 12 cigarettes per day;&#xD;
&#xD;
          5. History of severe or multiple allergies manifested by anaphylaxis;&#xD;
&#xD;
          6. Previous tissue revitalization therapy in the treatment area within 6 months before&#xD;
             treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy,&#xD;
             chemical peeling, or dermabrasion;&#xD;
&#xD;
          7. Subjects presenting with known allergy to hyaluronic acid (HA) filler or amide local&#xD;
             anesthetics.&#xD;
&#xD;
          8. Subjects presenting with porphyria.&#xD;
&#xD;
          9. Subjects with active disease, such as inflammation, infection or tumors, in or near&#xD;
             the intended treatment site.&#xD;
&#xD;
         10. Subjects with bleeding disorders or in subjects who are taking thrombolytics or&#xD;
             anticoagulants.&#xD;
&#xD;
         11. Subjects using immunosuppressants.&#xD;
&#xD;
         12. History of other décolletage treatment/procedure in the previous 6 months below the&#xD;
             level of the neck that, in the treating investigator's opinion, would interfere with&#xD;
             the study injections and/or study assessments or exposes the subject to undue risk by&#xD;
             study participation.&#xD;
&#xD;
         13. Tattoos, piercings or visible markings that in the treating investigator's opinion,&#xD;
             may interfere with results or assessments [excessive sun damage, tan lines, dark&#xD;
             spots, moles, scars (hypertrophic, keloid), tan lines].&#xD;
&#xD;
         14. Cancer or precancer in the treatment area, e.g. actinic keratosis;&#xD;
&#xD;
         15. History of bleeding disorders or treatment with thrombolytics, anticoagulants, or&#xD;
             inhibitors of platelet aggregation (e.g. Aspirin or other non-steroid&#xD;
             anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment;&#xD;
&#xD;
         16. Patients using immunosuppressants;&#xD;
&#xD;
         17. Patients with a tendency to form hypertrophic scars or any other healing disorders;&#xD;
&#xD;
         18. Patients with known hypersensitivity to lidocaine or agents structurally related to&#xD;
             amide type local anesthetics (e.g., certain anti-arrhythmics);&#xD;
&#xD;
         19. Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic&#xD;
             function or severe renal dysfunction.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</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>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 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>
  <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/NCT04488939
org study id: 2020-Gal-SBV
nct id: NCT04488939
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Restylane® Skinboosters™ Vital (SBV) is a smooth formulation without particles, which helps
      it distribute evenly and smoothly under the skin to aid in rejuvenation. This feature makes
      RSV particularly well suited for more superficial injections, such as at the level of the
      dermis.

      SBV smooths fine lines and wrinkles and is intended to improve skin smoothness and
      appearance, as well as the elasticity and hydration of the skin in the face and dorsal hands.
      However, many clinicians have used SBV in other regions of the body. Given these attributes,
      SBV are particularly well suited for photo aged skin. A region that is susceptible to
      photo-ageing and may therefore benefit from the use of SBV is the décolletage. Photodamaged
      skin of the chest is characterized by atrophy, skin laxity, fine lines and wrinkles,
      dehydration and tactile roughness. Therefore, SBV may help to improve these signs of aging in
      the décolletage region.

      Study Aim: To investigate the effectiveness and tolerability of SBV for rejuvenation of the
      décolletage region.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Galderma Décolletage Scale
time frame: Visit 4, Week 12
description: Proportion of subjects achieving at least a one-point improvement on the Galderma Décolletage Scale (GDS), one month following the treatment regime (i.e., Visit 4; Week 12; one month after completing three treatments, each spaced one month apart). Scores: 0 (none) to 4 (severe)
measure: Galderma Décolletage Scale
time frame: Visit 5 and 6 (Weeks 16 and 20)
description: Proportion of subjects achieving at least a one-point improvement on the Galderma Décolletage Scale , at Visits 5 and 6 (i.e., 2- and 3-months post treatment regime). Scores: 0 (non) to 4 (severe)
arm group label: Bilateral treatment
arm group type: Experimental
intervention type: Device
intervention name: Restylane® Skinboosters™ Vital (SBV)
description: Hyaluronic acid
arm group label: Bilateral treatment
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andreas Nikolis, FRCSC
role: Principal Investigator
affiliation: Erevna Innovations Inc.
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No