<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/NCT04505319</url>
  </required_header>
  <id_info>
    <org_study_id>ReGl/19/Dfc-Res/001</org_study_id>
    <nct_id>NCT04505319</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the Safety and Performance of a Filler in Correction of Mid-face Age-related Volume Deficit</brief_title>
  <official_title>Prospective, Single Center Study for the Clinical Evaluation of the Safety and Performance of a Dermal Filler in Correction of Mid-face Age-related Volume Deficit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Relife S.r.l.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Relife S.r.l.</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>
      Prospective, single center study, on healthy subjects to evaluate the aesthetic improvement&#xD;
      of facial volume, effect on the restoration and/or augmentation in subjects with mid-face&#xD;
      age-related volume deficit after injection of a filler with lidocaine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, non comparative, single center study, on healthy female subjects. The scope is&#xD;
      to evaluate the performance and safety of a dermal filler (definisse core filler plus&#xD;
      lidocaine) to evaluate the aesthetic improvement of facial volume, effect on the restoration&#xD;
      and/or augmentation in subjects with mid-face age-related volume deficit after injection of a&#xD;
      filler with lidocaine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2020</start_date>
  <completion_date type="Actual">April 8, 2022</completion_date>
  <primary_completion_date type="Actual">April 8, 2022</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>prospective,&#xD;
non comparative&#xD;
single centre,&#xD;
on healthy subjects.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global aesthetic improvement one month</measure>
    <time_frame>one month after injection (first visit from Day 0)</time_frame>
    <description>Clinical evaluation of the global aesthetic improvement (GAIS) one month after injection of the investigational medical device in subjects with mid-face age-related volume deficit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global aesthetic improvement during follow up</measure>
    <time_frame>3, 6, 9, 12 and 18 months after injection</time_frame>
    <description>Clinical evaluation of the global aesthetic improvement (GAIS) 3, 6, 9, 12 and 18 months after injection of the investigational medical device in subjects with mid-face age-related volume deficit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical evaluation on restoration and/or augmentation of facial volume</measure>
    <time_frame>from baseline (Day 0) to 1, 3, 6, 9, 12 and 18 months</time_frame>
    <description>Clinical evaluation of the investigational medical device effect on the restoration and/or augmentation of facial volume, with a clinical scale (FVLS) Face Volume Loss Scale, with a score from Grade 1 to Grade 5, when Grade 1 is the better outcome .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need of a touch-up injection</measure>
    <time_frame>after one month of injection (Month 1)</time_frame>
    <description>evaluation if a touch up injection is needed after one month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective evaluation on restoration and/or augmentation of facial volume</measure>
    <time_frame>from baseline (Day 0) to 1, 3, 6, 9, 12 and 18 months</time_frame>
    <description>Objective evaluation of the investigational medical device effect on the restoration and/or augmentation of facial volume, with cheekbone volume variation evaluation by 3D LifeViz® system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>subject satisfaction on Aesthetic improvement</measure>
    <time_frame>at each time point after injection, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months.</time_frame>
    <description>Evaluation of subject satisfaction using a subjective evaluation questionnaire, (GAIS) Global Aesthetic improvement Scale, the scores is from 1 to 5, when 1 is the better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of injector satisfaction on using medical device</measure>
    <time_frame>During the injection Day 0 and 1 one month after the first injection (Month 1)</time_frame>
    <description>Evaluation of injector satisfaction using a subjective evaluation questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluation on skin quality after injection with Dermascan</measure>
    <time_frame>from baseline (Day 0) to 3, 6, 9, 12 and 18 months after initial injection</time_frame>
    <description>Objective evaluation of the investigational medical device effect on skin quality using Dermascan instrument</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluation on skin thickness after injection with Dermascan</measure>
    <time_frame>from baseline (Day 0) to 3, 6, 9, 12 and 18 months after initial injection</time_frame>
    <description>Objective evaluation of the investigational medical device effect on skin thickness using Dermascan instrument</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluation onskin biomechanical properties after injection with Cutometer</measure>
    <time_frame>from baseline (Day 0) to 3, 6, 9, 12 and 18 months after initial injection</time_frame>
    <description>Objective evaluation of the investigational medical device effect on skin biomechanical properties measurements using Cutometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of product safety</measure>
    <time_frame>1 month after each injection for ISRs and 21 months for adverse event collection</time_frame>
    <description>Clinical evaluation of the investigational medical device safety with Injection Site Reactions (ISRs) and adverse event collection</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Aesthetics</condition>
  <condition>Intradermal Injections</condition>
  <arm_group>
    <arm_group_label>DEFINISSE CORE FILLER</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cross linked sodium hyaluronate 25 mg/ml with 0,3% lidocaine hydrochloride will be inject during the first visit and a touch up after one month if indicated by the physician.&#xD;
The filler will inject in the face.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DEFINISSE CORE FILLER</intervention_name>
    <description>DEFINISSE CORE FILLER volume will be injected between 4.0 of 5.0 ml on the whole face (at the discretion of the treating physician to achieve an optimal aesthetic result).&#xD;
A touch-up will be possible at the first follow-up visit (after one month) with a amount of product between 4.0 and 5.0 ml on the whole face</description>
    <arm_group_label>DEFINISSE CORE FILLER</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy subject;&#xD;
&#xD;
          2. Sex: female;&#xD;
&#xD;
          3. Age: between 40 and 60 years;&#xD;
&#xD;
          4. BMI between 18 and 25 included.&#xD;
&#xD;
          5. Subject having given freely and expressly his informed consent;&#xD;
&#xD;
          6. Subject with a volume deficit on malar area and requiring a correction using a filler;&#xD;
&#xD;
          7. Subject, psychologically able to understand the study related information and to give&#xD;
             a written informed consent;&#xD;
&#xD;
          8. Subject affiliated to a health social security system;&#xD;
&#xD;
          9. Female of childbearing potential using a medically accepted contraceptive regimen&#xD;
             since at least 12 weeks before the beginning of the study and during all the study&#xD;
             (oral contraceptives, patch contraceptives, injection contraceptives, male condom with&#xD;
             intra-vaginal spermicide, diaphragm or cervical cap with spermicide, vaginal&#xD;
             contraceptive ring, intrauterine device, surgical sterilization (bilateral tubal&#xD;
             ligation), vasectomized partner, or sexual abstinence).&#xD;
&#xD;
         10. Female subjects of childbearing potential must have a negative pregnancy test at the&#xD;
             inclusion;&#xD;
&#xD;
         11. Subject agreeing to keep their usual cleansing / care products on the face during the&#xD;
             whole study period;&#xD;
&#xD;
         12. Whole full teething subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or nursing woman or planning a pregnancy during the study.&#xD;
&#xD;
          2. Subject who had been deprived of their freedom by administrative or legal decision or&#xD;
             who is under guardianship.&#xD;
&#xD;
          3. Subject in a social or sanitary establishment.&#xD;
&#xD;
          4. Subject participating to another research on human beings or being in an exclusion&#xD;
             period for a previous study.&#xD;
&#xD;
          5. Subject having received 4500 euros indemnities for participation in researches&#xD;
             involving human beings in the 12 previous months, including participation in the&#xD;
             present study.&#xD;
&#xD;
          6. Intensive exposure to sunlight or UV-rays within the previous month and foreseen&#xD;
             during the study.&#xD;
&#xD;
          7. Subject with a tattoo, a scar, moles, pigment disorders or anything on the studied&#xD;
             zones which may interfere with the study at the investigator appreciation.&#xD;
&#xD;
          8. Subject with unstable weight or planning to do a dietary regime during the study.&#xD;
&#xD;
          9. Subject with too severe mid-face volume deficit.&#xD;
&#xD;
         10. Subjects without teeth or with dental prostheses&#xD;
&#xD;
         11. Subject with severe, ongoing and uncontrolled diseases such as malignancy or history&#xD;
             of malignancy, type I diabetes, liver failure, renal failure, lung/heart disease,&#xD;
             neoplasia, malignant blood disease, tumor, HIV, epilepsy, porphyria or other major&#xD;
             disease, likely to interfere with the measured parameters or to put the subject to an&#xD;
             undue risk.&#xD;
&#xD;
         12. Subject with known history of or suffering from autoimmune disease and/or immune&#xD;
             deficiency&#xD;
&#xD;
         13. Subject with current cutaneous inflammatory or infectious processes (eg, acne, herpes,&#xD;
             mycosis, papilloma, chronic eczema, atopic dermatitis …), abscess, unhealed wound, or&#xD;
             a cancerous or precancerous lesion on the studied zone.&#xD;
&#xD;
         14. Subject having history of anaphylactic shock or know allergy or hypersensitivity to&#xD;
             hyaluronic acid or to one of the components of the tested device, antiseptic solution,&#xD;
             lidocaine hydrochloride or to amide-type local anaesthetics.&#xD;
&#xD;
         15. Subject predisposed to keloids or hypertrophic scarring.&#xD;
&#xD;
         16. Subject with coagulation and/or homeostasis disorders.&#xD;
&#xD;
         17. Subject with a past history of streptococcal disease, such as acute rheumatic fever or&#xD;
             recurrent sore throats;&#xD;
&#xD;
         18. Subject having received treatment with a laser, a dermabrasion, a surgery, a chemical&#xD;
             peeling, mesotherapy or other ablative procedure on the face within the past 12 months&#xD;
             prior to inclusion;&#xD;
&#xD;
         19. Subject having received injection with a reabsorbable filling product in the face area&#xD;
             within the past 12 months prior to inclusion;&#xD;
&#xD;
         20. Subject having received at any time injection with a slowly reabsorbable filling&#xD;
             product (polylactic acid, calcium hydroxyapatite, combinations of hyaluronic acid (HA)&#xD;
             and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate (TCP), …)&#xD;
             or with a non-resorbable filling product (polyacrylamide, silicone, combination of&#xD;
             methacrylic polymers and collagen, polymer particles, …);&#xD;
&#xD;
         21. Subject having received at any time a treatment with suspension threads in the face;&#xD;
&#xD;
         22. Any medication which may interfere, at the interpretation of the investigator, with&#xD;
             the study objectives in term of efficacy and safety.&#xD;
&#xD;
         23. Subject under medications which may cause lipoatrophy;&#xD;
&#xD;
         24. Subject using medication such as aspirin, NSAIDs (ibuprofen, naproxen, …),&#xD;
             antiplatelet agents, anticoagulants, high-doses vitamin C within 10 days prior to&#xD;
             inclusion or being a chronic user;&#xD;
&#xD;
         25. Subject having received chemotherapy agents, immunosuppressive medications or systemic&#xD;
             corticosteroids within 3 months of enrolment and during the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Siham RHARBAOUI</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eurofins Laboratoire Dermscan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eurofins Laboratoire Dermscan</name>
      <address>
        <city>Villeurbanne</city>
        <zip>69100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>DERMAL FILLER</keyword>
  <keyword>sodium hyaluronate</keyword>
  <keyword>RELIFE</keyword>
  <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/NCT04505319
org study id: ReGl/19/Dfc-Res/001
nct id: NCT04505319
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective, single center study, on healthy subjects to evaluate the aesthetic improvement
      of facial volume, effect on the restoration and/or augmentation in subjects with mid-face
      age-related volume deficit after injection of a filler with lidocaine.
Prospective, non comparative, single center study, on healthy female subjects. The scope is
      to evaluate the performance and safety of a dermal filler (definisse core filler plus
      lidocaine) to evaluate the aesthetic improvement of facial volume, effect on the restoration
      and/or augmentation in subjects with mid-face age-related volume deficit after injection of a
      filler with lidocaine.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: prospective,
non comparative
single centre,
on healthy subjects.
primary purpose: Treatment
masking: None (Open Label)
measure: Global aesthetic improvement one month
time frame: one month after injection (first visit from Day 0)
description: Clinical evaluation of the global aesthetic improvement (GAIS) one month after injection of the investigational medical device in subjects with mid-face age-related volume deficit.
measure: Global aesthetic improvement during follow up
time frame: 3, 6, 9, 12 and 18 months after injection
description: Clinical evaluation of the global aesthetic improvement (GAIS) 3, 6, 9, 12 and 18 months after injection of the investigational medical device in subjects with mid-face age-related volume deficit.
measure: Clinical evaluation on restoration and/or augmentation of facial volume
time frame: from baseline (Day 0) to 1, 3, 6, 9, 12 and 18 months
description: Clinical evaluation of the investigational medical device effect on the restoration and/or augmentation of facial volume, with a clinical scale (FVLS) Face Volume Loss Scale, with a score from Grade 1 to Grade 5, when Grade 1 is the better outcome .
measure: Need of a touch-up injection
time frame: after one month of injection (Month 1)
description: evaluation if a touch up injection is needed after one month
measure: Objective evaluation on restoration and/or augmentation of facial volume
time frame: from baseline (Day 0) to 1, 3, 6, 9, 12 and 18 months
description: Objective evaluation of the investigational medical device effect on the restoration and/or augmentation of facial volume, with cheekbone volume variation evaluation by 3D LifeViz® system
measure: subject satisfaction on Aesthetic improvement
time frame: at each time point after injection, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months.
description: Evaluation of subject satisfaction using a subjective evaluation questionnaire, (GAIS) Global Aesthetic improvement Scale, the scores is from 1 to 5, when 1 is the better outcome.
measure: Evaluation of injector satisfaction on using medical device
time frame: During the injection Day 0 and 1 one month after the first injection (Month 1)
description: Evaluation of injector satisfaction using a subjective evaluation questionnaire
measure: evaluation on skin quality after injection with Dermascan
time frame: from baseline (Day 0) to 3, 6, 9, 12 and 18 months after initial injection
description: Objective evaluation of the investigational medical device effect on skin quality using Dermascan instrument
measure: evaluation on skin thickness after injection with Dermascan
time frame: from baseline (Day 0) to 3, 6, 9, 12 and 18 months after initial injection
description: Objective evaluation of the investigational medical device effect on skin thickness using Dermascan instrument
measure: evaluation onskin biomechanical properties after injection with Cutometer
time frame: from baseline (Day 0) to 3, 6, 9, 12 and 18 months after initial injection
description: Objective evaluation of the investigational medical device effect on skin biomechanical properties measurements using Cutometer
measure: Evaluation of product safety
time frame: 1 month after each injection for ISRs and 21 months for adverse event collection
description: Clinical evaluation of the investigational medical device safety with Injection Site Reactions (ISRs) and adverse event collection
arm group label: DEFINISSE CORE FILLER
arm group type: Experimental
description: Cross linked sodium hyaluronate 25 mg/ml with 0,3% lidocaine hydrochloride will be inject during the first visit and a touch up after one month if indicated by the physician.
The filler will inject in the face.
intervention type: Device
intervention name: DEFINISSE CORE FILLER
description: DEFINISSE CORE FILLER volume will be injected between 4.0 of 5.0 ml on the whole face (at the discretion of the treating physician to achieve an optimal aesthetic result).
A touch-up will be possible at the first follow-up visit (after one month) with a amount of product between 4.0 and 5.0 ml on the whole face
arm group label: DEFINISSE CORE FILLER
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Siham RHARBAOUI
role: Principal Investigator
affiliation: Eurofins Laboratoire Dermscan
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No