<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/NCT03756168</url>
  </required_header>
  <id_info>
    <org_study_id>CS0518</org_study_id>
    <nct_id>NCT03756168</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser (Flanks)</brief_title>
  <official_title>Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser for Non-invasive Fat Reduction of the Flanks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Venus Concept</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Venus Concept</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this clinical study is to assess the safety and efficacy of using a 1060 nm&#xD;
      diode laser for non-invasive fat reduction of the flanks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Open-label, baseline-controlled, evaluator-blind, multi-center study evaluating a 1060 nm&#xD;
      diode laser for non-invasive fat reduction of the flanks. The study will enroll up to 50&#xD;
      subjects requesting non-invasive lipolysis of the flanks. Each subject will receive a single&#xD;
      study treatment. Subjects will be followed at six weeks and twelve weeks post-treatment.&#xD;
      Twelve week outcome will be compared to baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2018</start_date>
  <completion_date type="Actual">July 2, 2019</completion_date>
  <primary_completion_date type="Actual">July 2, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Photographic evaluation</measure>
    <time_frame>week 12</time_frame>
    <description>Photographic evaluation by indepependant blinded reviewers with correct identification of pre-treatment baseline images when compared to post-treatment images taken at twelve weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fat thickness</measure>
    <time_frame>week 12</time_frame>
    <description>to determine the change in thickness of the adipose layer as measured by ultrasound at 12 weeks post treatment as compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in abdominal circumference</measure>
    <time_frame>week 12</time_frame>
    <description>to determine the change in the abdominal circumference at 12 weeks post treatment as compare to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject satisfaction: Likert subject satisfaction scale</measure>
    <time_frame>week 12</time_frame>
    <description>to assess subject satisfaction with treatment at 12 weeks using the 5 point Likert subject satisfaction scale. 5 points ranging from 5 which is very satisfied to 1which is very unsatisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Safety: Subjects experiencing a treatment related adverse event</measure>
    <time_frame>week 12</time_frame>
    <description>Subjects experiencing a treatment related adverse event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comfort: Wong Baker Faces Scale</measure>
    <time_frame>week 1</time_frame>
    <description>Subject assessment of discomfort and pain post treatment as measured by the Wong Baker Faces Scale. Pain tolerance is asked of the subject measuring on a scale from 0-10 (10 worst pain ever to 0 which is no pain at all)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Fat Atrophy</condition>
  <arm_group>
    <arm_group_label>Treatment subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single group of subjects with will have the treatment of a 1060 nm diode laser administered to them</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>1060nm Diode laser</intervention_name>
    <description>Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.</description>
    <arm_group_label>Treatment subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  able to read, understand and voluntarily provide written informed consent&#xD;
&#xD;
          -  healthy male or female &gt; 18 years of age seeking treatment for unwanted fat in the&#xD;
             abdomen&#xD;
&#xD;
          -  BMI score is less then 30&#xD;
&#xD;
          -  agree to not making any major changes in their diet or lifestyle during the course of&#xD;
             the study&#xD;
&#xD;
          -  able and willing to comply with the treatment / follow up schedule and requirements&#xD;
&#xD;
          -  women of child-bearing age are required to be using a reliable method of birth control&#xD;
             at least 3 months prior to study enrolment and for the duration of the study, have a&#xD;
             negative urine pregnancy test baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant in the last 3 months intending to become pregnant, postpartum or nursing in&#xD;
             the last 6 months&#xD;
&#xD;
          -  any previous liposuction / lipo-sculpture or any type of surgical procedure in the&#xD;
             treatment area in the past 12 months&#xD;
&#xD;
          -  history of immunosuppression / immune deficiency disorders including AIDS and HIV&#xD;
             infection, or use of immunosuppressive medications, 6 month prior to and during the&#xD;
             course of the study&#xD;
&#xD;
          -  History of hyperlipidemia, diabetes, hepatitis, blood coagulopathy or excessive&#xD;
             bleeding&#xD;
&#xD;
          -  Use of antiplatelet medications (81 mg of acetylsalicylic acid daily is permitted),&#xD;
             anticoagulants, thrombocytes or any-inflammatory medications within 2 weeks of&#xD;
             treatment&#xD;
&#xD;
          -  Having a history of skin cancer or any other cancer in the area to be treated,&#xD;
             including presence of malignant or pre-malignant pigmented lesions&#xD;
&#xD;
          -  Having a permanent implant in the treatment area such as a metal plate or injected&#xD;
             chemical substance such as silicone pr parenteral gold therapy (gold sodium&#xD;
             thiomalate)&#xD;
&#xD;
          -  Use of medications, herbs or food supplements and vitamins known to induce&#xD;
             photosensitivity to light exposure at the wavelength used history of photosensitivity&#xD;
             disorder&#xD;
&#xD;
          -  Suffering from significant skin conditions in the treatment area or inflammatory skin&#xD;
             conditions including but not limited to open lacerations, abrasions, herpes sores,&#xD;
             cold sores, active infections&#xD;
&#xD;
          -  Tattoos in the treatment area&#xD;
&#xD;
          -  Poor quality skin (laxity)&#xD;
&#xD;
          -  Abdominal wall, muscular abnormality or hernia on physical examination&#xD;
&#xD;
          -  Unstable weight within the last 6 months (+ or - 3% weight change in the prior six&#xD;
             months)&#xD;
&#xD;
          -  Participation in another clinical study involving the same anatomical areas within the&#xD;
             last 6 months&#xD;
&#xD;
          -  History of keloid and hypertrophic scar formation or poor wound healing in the&#xD;
             treatment area&#xD;
&#xD;
          -  As per the investigators discretion any physician or mental condition which may make&#xD;
             it unsafe for the subject to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Suzanne Kilmer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Skin and Laser Centre of Northern California</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffery Kenkel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laser and Skin Surgery Center of Northern California</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Centre</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Decorato JW, Chen B, Sierra R. Subcutaneous adipose tissue response to a non-invasive hyperthermic treatment using a 1,060 nm laser. Lasers Surg Med. 2017 Jul;49(5):480-489. doi: 10.1002/lsm.22625. Epub 2017 Jan 19.</citation>
    <PMID>28103642</PMID>
  </results_reference>
  <results_reference>
    <citation>Katz B, Doherty S. Safety and Efficacy of a Noninvasive 1,060-nm Diode Laser for Fat Reduction of the Flanks. Dermatol Surg. 2018 Mar;44(3):388-396. doi: 10.1097/DSS.0000000000001298.</citation>
    <PMID>28902034</PMID>
  </results_reference>
  <results_reference>
    <citation>McBean JC, Katz BE. Laser lipolysis: an update. J Clin Aesthet Dermatol. 2011 Jul;4(7):25-34. No abstract available.</citation>
    <PMID>21779417</PMID>
  </results_reference>
  <results_reference>
    <citation>Schilling L, Saedi N, Weiss R. 1060 nm Diode Hyperthermic Laser Lipolysis:The Latest in Non-Invasive Body Contouring. J Drugs Dermatol. 2017 Jan 1;16(1):48-52.</citation>
    <PMID>28095532</PMID>
  </results_reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>October 29, 2020</last_update_submitted>
  <last_update_submitted_qc>October 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2020</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>Atrophy</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/NCT03756168
org study id: CS0518
nct id: NCT03756168
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The objective of this clinical study is to assess the safety and efficacy of using a 1060 nm
      diode laser for non-invasive fat reduction of the flanks.
Open-label, baseline-controlled, evaluator-blind, multi-center study evaluating a 1060 nm
      diode laser for non-invasive fat reduction of the flanks. The study will enroll up to 50
      subjects requesting non-invasive lipolysis of the flanks. Each subject will receive a single
      study treatment. Subjects will be followed at six weeks and twelve weeks post-treatment.
      Twelve week outcome will be compared to baseline.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Photographic evaluation
time frame: week 12
description: Photographic evaluation by indepependant blinded reviewers with correct identification of pre-treatment baseline images when compared to post-treatment images taken at twelve weeks
measure: Fat thickness
time frame: week 12
description: to determine the change in thickness of the adipose layer as measured by ultrasound at 12 weeks post treatment as compared to baseline
measure: Change in abdominal circumference
time frame: week 12
description: to determine the change in the abdominal circumference at 12 weeks post treatment as compare to baseline
measure: Subject satisfaction: Likert subject satisfaction scale
time frame: week 12
description: to assess subject satisfaction with treatment at 12 weeks using the 5 point Likert subject satisfaction scale. 5 points ranging from 5 which is very satisfied to 1which is very unsatisfied
measure: Subject Safety: Subjects experiencing a treatment related adverse event
time frame: week 12
description: Subjects experiencing a treatment related adverse event
measure: Comfort: Wong Baker Faces Scale
time frame: week 1
description: Subject assessment of discomfort and pain post treatment as measured by the Wong Baker Faces Scale. Pain tolerance is asked of the subject measuring on a scale from 0-10 (10 worst pain ever to 0 which is no pain at all)
arm group label: Treatment subjects
arm group type: Experimental
description: Single group of subjects with will have the treatment of a 1060 nm diode laser administered to them
intervention type: Device
intervention name: 1060nm Diode laser
description: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.
arm group label: Treatment subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Suzanne Kilmer, MD
role: Principal Investigator
affiliation: Skin and Laser Centre of Northern California
last name: Jeffery Kenkel, MD
role: Principal Investigator
affiliation: UT Southwestern
facility: 
facility: 
country: United States
citation: Decorato JW, Chen B, Sierra R. Subcutaneous adipose tissue response to a non-invasive hyperthermic treatment using a 1,060 nm laser. Lasers Surg Med. 2017 Jul;49(5):480-489. doi: 10.1002/lsm.22625. Epub 2017 Jan 19.
PMID: 28103642
citation: Katz B, Doherty S. Safety and Efficacy of a Noninvasive 1,060-nm Diode Laser for Fat Reduction of the Flanks. Dermatol Surg. 2018 Mar;44(3):388-396. doi: 10.1097/DSS.0000000000001298.
PMID: 28902034
citation: McBean JC, Katz BE. Laser lipolysis: an update. J Clin Aesthet Dermatol. 2011 Jul;4(7):25-34. No abstract available.
PMID: 21779417
citation: Schilling L, Saedi N, Weiss R. 1060 nm Diode Hyperthermic Laser Lipolysis:The Latest in Non-Invasive Body Contouring. J Drugs Dermatol. 2017 Jan 1;16(1):48-52.
PMID: 28095532
responsible party type: Sponsor
mesh term: Atrophy
sharing ipd: No