<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/NCT04477187</url>
  </required_header>
  <id_info>
    <org_study_id>STU-2020-0593</org_study_id>
    <nct_id>NCT04477187</nct_id>
  </id_info>
  <brief_title>Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling</brief_title>
  <official_title>Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of bipolar fractional&#xD;
      radiofrequency treatment via use of the Profound System to achieve skin tightening and&#xD;
      contour change in lax submental (beneath the chin) tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center, unblinded, non-randomized, non-controlled study designed to follow a&#xD;
      total of up to 15 qualified and consenting subjects to receive one bipolar fractional&#xD;
      radiofrequency microneedling treatment under an IRB approved protocol. Up to 15 subjects will&#xD;
      be enrolled and treated at UT Southwestern in the Department of Plastic Surgery. Subjects&#xD;
      will be identified from the clinical practice of Dr. Jeffrey Kenkel, Department of Plastic&#xD;
      Surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">December 22, 2022</completion_date>
  <primary_completion_date type="Actual">June 13, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Volume change in the submental region</measure>
    <time_frame>Baseline - 6 Months (Day 180)</time_frame>
    <description>Improvement will be assessed by change in the surface area assessments of baseline (pre-procedure) and 6 months (post-procedure).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence, severity, and relatedness of adverse events</measure>
    <time_frame>Baseline - 6 Months (Day 180)</time_frame>
    <description>The number and level of severity of adverse events after treatment. An assessment will be made by the PI to determine if the adverse event is related to the study device and/or procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in overall lift: H2 and Stand Up Vectra</measure>
    <time_frame>Baseline - 6 Months (Day 180)</time_frame>
    <description>Blinded evaluators will be asked to evaluate photographs obtained via the H2 3D Imaging System and Stand Up Vectra (Canfield) of the subjects at baseline (pre-treatment) and 6 months (post-treatment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Assessments: Global Aesthetic Improvement Score</measure>
    <time_frame>Baseline - 6 Months (Day 180)</time_frame>
    <description>Blinded reviewers will assessment and score using a 5-point Global Aesthetic Improvement Score (1=Very Much Improved, 5= worse)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects Assessment of Pain: Numerical Pain Rating Scale</measure>
    <time_frame>Through study completion, an average of 6 Months (Day 180)</time_frame>
    <description>The subjects' assessment of pain will be completed using an 11-point Numerical Pain Scale (0= No pain, 10= Extreme pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Non-invasive Measurements: Aquaflux</measure>
    <time_frame>Baseline - 6 Months (Day 180)</time_frame>
    <description>Skin texture and laxity will be assessed using non invasive skin measurements.&#xD;
Biox Aquaflux- will be used to measure transepidermal water loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Non-invasive Measurements: OCT</measure>
    <time_frame>Baseline - 6 Months (Day 180)</time_frame>
    <description>Skin texture and laxity will be assessed using non invasive skin measurements.&#xD;
Optical coherence tomography will be used to topographical and histological images of the skin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Non-invasive Measurements : BTC2000</measure>
    <time_frame>Baseline - 6 Months (Day 180)</time_frame>
    <description>Skin texture and laxity will be assessed using non invasive skin measurements.&#xD;
BTC2000- will be used to measure skin laxity values of the skin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Non-invasive Measurements : BTC2000</measure>
    <time_frame>Baseline - 6 Months (Day 180)</time_frame>
    <description>Skin texture and laxity will be assessed using non invasive skin measurements.&#xD;
BTC2000- will be used to measure elasticity of the skin.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Skin Laxity</condition>
  <arm_group>
    <arm_group_label>Single Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dermal Handpiece</intervention_name>
    <description>Radiofrequency (RF) will travel through the RF generator through the electrodes and into the dermal layer beneath the surface of the skin. The microneedles of the dermal cartridges coupled with the thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.</description>
    <arm_group_label>Single Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female adults between ages 21-70 years of age.&#xD;
&#xD;
          -  Desire skin laxity lift of the submental region.&#xD;
&#xD;
          -  Confirmed BMI ≤ 35.&#xD;
&#xD;
          -  Subjects who can read, understand, and sign the Informed Consent Form.&#xD;
&#xD;
          -  Subjects willing and able to comply with all study requirements.&#xD;
&#xD;
          -  Fitzpatrick skin type I-VI.&#xD;
&#xD;
          -  Submental fat graded by the Investigator as ≥ 1 using the Clinician-Reported Submental&#xD;
             Fat Rating Scale&#xD;
&#xD;
          -  Subject is willing not to undergo any type of aesthetic procedure that could confound&#xD;
             the study device treatment effects until he/she completes the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active localized or systemic infections, that may alter wound healing.&#xD;
&#xD;
          -  Immunocompromised subjects.&#xD;
&#xD;
          -  Subjects with coagulation disorder.&#xD;
&#xD;
          -  History of skin photosensitivity disorders, or use of photosensitizing drugs (e.g.,&#xD;
             tetracycline or sulfa drugs).&#xD;
&#xD;
          -  Pregnant and/or lactating (All female volunteers will be advised about using birth&#xD;
             control during the period of study).&#xD;
&#xD;
          -  Excessive skin laxity on the submental and neck (Submental Skin Laxity Grade: SMSLG 4,&#xD;
             Appendix E), or other anatomical feature for which reduction in SMF which may, in the&#xD;
             judgment of the investigator, result in an aesthetically unacceptable outcome.&#xD;
&#xD;
          -  Scarring in areas to be treated.&#xD;
&#xD;
          -  Tattoos in the treatment areas to be treated.&#xD;
&#xD;
          -  Significant open facial wounds or lesions.&#xD;
&#xD;
          -  Severe or cystic acne in treatment areas.&#xD;
&#xD;
          -  Current active smoker.&#xD;
&#xD;
          -  Use of Accutane (Isotretinoin) within the past 6 months.&#xD;
&#xD;
          -  Use of topical retinoids within 48 hours.&#xD;
&#xD;
          -  Use of prescription anticoagulants.&#xD;
&#xD;
          -  Pacemaker or internal defibrillator.&#xD;
&#xD;
          -  History of skin disorders resulting in abnormal wound healing (i.e. keloids, extreme&#xD;
             dry and fragile skin).&#xD;
&#xD;
          -  Subjects on current oral corticosteroid therapy or within the past 6 months&#xD;
&#xD;
          -  Metal implants in the treatment area.&#xD;
&#xD;
          -  In the opinion of the investigator, subject is unwilling or unable to adhere to all&#xD;
             study requirements, including application and follow-up visits.&#xD;
&#xD;
          -  Subjects with a history of radiation therapy to the treatment area.&#xD;
&#xD;
          -  Subject has a history of allergy to lidocaine or ester-based local anesthetics.&#xD;
&#xD;
          -  Subjects with significant cardiac history or rhythm disturbance who may be unable to&#xD;
             tolerate lidocaine with epinephrine.&#xD;
&#xD;
          -  Subjects with any skin pathology or condition in the treatment area that could&#xD;
             interfere with evaluation or with the use of typical ancillary medical treatments or&#xD;
             care used before, during or after treatments (e.g. psoriasis, rosacea, eczema,&#xD;
             seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions such as&#xD;
             post inflammatory hyperpigmentation).&#xD;
&#xD;
          -  Subjects who are unwilling to shave excessive hair in the treatment area that might&#xD;
             influence or impair evaluation in the opinion of the Investigator.&#xD;
&#xD;
          -  Subjects have undergone skin resurfacing or tightening treatments in the treatment&#xD;
             area over the past year.&#xD;
&#xD;
          -  Subjects have undergone dermatological treatments such as fillers and neurotoxins for&#xD;
             the past 6 months in the treatment area.&#xD;
&#xD;
          -  Subjects have undergone laser and light treatments in the treatment area over the past&#xD;
             3 months.&#xD;
&#xD;
          -  Subjects have undergone superficial peel or microdermabrasion within 4 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Kenkel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UT Southwestern Medical Center- Dept of Plastic Surgery</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>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Jeffrey M. Kenkel</investigator_full_name>
    <investigator_title>Professor and Chair Department of Plastic Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cutis Laxa</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>June 5, 2023</submitted>
    <returned>June 27, 2023</returned>
    <submitted>July 27, 2023</submitted>
    <returned>August 15, 2023</returned>
    <submitted>September 11, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04477187
org study id: STU-2020-0593
nct id: NCT04477187
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The purpose of this study is to evaluate the safety and efficacy of bipolar fractional
      radiofrequency treatment via use of the Profound System to achieve skin tightening and
      contour change in lax submental (beneath the chin) tissue.
This is a single-center, unblinded, non-randomized, non-controlled study designed to follow a
      total of up to 15 qualified and consenting subjects to receive one bipolar fractional
      radiofrequency microneedling treatment under an IRB approved protocol. Up to 15 subjects will
      be enrolled and treated at UT Southwestern in the Department of Plastic Surgery. Subjects
      will be identified from the clinical practice of Dr. Jeffrey Kenkel, Department of Plastic
      Surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Volume change in the submental region
time frame: Baseline - 6 Months (Day 180)
description: Improvement will be assessed by change in the surface area assessments of baseline (pre-procedure) and 6 months (post-procedure).
measure: Incidence, severity, and relatedness of adverse events
time frame: Baseline - 6 Months (Day 180)
description: The number and level of severity of adverse events after treatment. An assessment will be made by the PI to determine if the adverse event is related to the study device and/or procedure.
measure: Improvement in overall lift: H2 and Stand Up Vectra
time frame: Baseline - 6 Months (Day 180)
description: Blinded evaluators will be asked to evaluate photographs obtained via the H2 3D Imaging System and Stand Up Vectra (Canfield) of the subjects at baseline (pre-treatment) and 6 months (post-treatment).
measure: Improvement in Assessments: Global Aesthetic Improvement Score
time frame: Baseline - 6 Months (Day 180)
description: Blinded reviewers will assessment and score using a 5-point Global Aesthetic Improvement Score (1=Very Much Improved, 5= worse)
measure: Subjects Assessment of Pain: Numerical Pain Rating Scale
time frame: Through study completion, an average of 6 Months (Day 180)
description: The subjects' assessment of pain will be completed using an 11-point Numerical Pain Scale (0= No pain, 10= Extreme pain)
measure: Improvement in Non-invasive Measurements: Aquaflux
time frame: Baseline - 6 Months (Day 180)
description: Skin texture and laxity will be assessed using non invasive skin measurements.
Biox Aquaflux- will be used to measure transepidermal water loss.
measure: Improvement in Non-invasive Measurements: OCT
time frame: Baseline - 6 Months (Day 180)
description: Skin texture and laxity will be assessed using non invasive skin measurements.
Optical coherence tomography will be used to topographical and histological images of the skin.
measure: Improvement in Non-invasive Measurements : BTC2000
time frame: Baseline - 6 Months (Day 180)
description: Skin texture and laxity will be assessed using non invasive skin measurements.
BTC2000- will be used to measure skin laxity values of the skin.
measure: Improvement in Non-invasive Measurements : BTC2000
time frame: Baseline - 6 Months (Day 180)
description: Skin texture and laxity will be assessed using non invasive skin measurements.
BTC2000- will be used to measure elasticity of the skin.
arm group label: Single Group
arm group type: Experimental
description: All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece.
intervention type: Device
intervention name: Dermal Handpiece
description: Radiofrequency (RF) will travel through the RF generator through the electrodes and into the dermal layer beneath the surface of the skin. The microneedles of the dermal cartridges coupled with the thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.
arm group label: Single Group
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffrey Kenkel, MD
role: Principal Investigator
affiliation: UT Southwestern
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Jeffrey M. Kenkel
investigator title: Professor and Chair Department of Plastic Surgery
mesh term: Cutis Laxa
submitted: June 5, 2023
returned: June 27, 2023
submitted: July 27, 2023
returned: August 15, 2023
submitted: September 11, 2023