Safety and Effectiveness Evaluation of the Device in Achieving Submental Lift
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      A prospective evaluation of the ThermiRF device in treating skin laxity under the chin and
      neck. Seventy male and female subjects between the age of 35 and 65 (inclusive) will be
      enrolled in this trial. The first 30 subjects will have a total of 6 study visits while the
      remainder will have a total of 5 study visits.

      All subjects will have a single treatment administered. The first 30 subjects will have an
      extra visit at Day 60 intended to allow collection of photo images post treatment to be used
      for the validation of three blinded raters.

      Photo images will be collected using 2D standard photography and 3D using the Vectra system.
      The architecture of the skin in the affected area will be measured using the Cutometer, a
      suction like instrument that measures elasticity. Sensory and safety will be measured using a
      0-10 point numerical rating scale (NRS) and collection of safety reports. The study duration
      is approximately 6 months.
    

Detailed description: 
      This is an open-label, single-center, single-treatment prospective evaluation of the ThermiRF
      device in the treatment of submental skin laxity. The purpose of this prospective study is to
      determine the effectiveness and safety of the ThermiRF device in achieving overall submental
      lift.

      In this study, "Lift" is defined as a ≥ 20 mm2 lift of the submental area after the ThermiRF
      treatment.

      A total of 70 male and female healthy volunteers between the age of 35 and 65 will be
      considered for this study. Subjects who sign the informed consent form and meet all entry
      criteria will be enrolled in this study and will be assigned a unique number/code to preserve
      confidentiality.

      A total of six study visits are planned as described below:

        -  Visit 1: Screening visit - (Day 1)

        -  Visit 2: Single Treatment visit

        -  Visit 3: Day 30 safety assessment (± 7 to 14 days)

        -  Visit 4: Day 60 safety and Image capture for validation exercise (± 7 to 14 days)

        -  Visit 5: Day 90 safety and effectiveness follow-up visit (± 7 to 14 days)

        -  Visit 6: Day 180 safety and effectiveness follow-up visit - (± 7 to 14 days)

      Photo images (2D and 3D) will be collected at Visits 1, Visit 4 (on first 30 subjects only),
      and at Visits 5 and 6 using a standard camera (2D) and the Vectra system (3D). The purpose of
      the photos are to quantitatively and qualitative evaluate treatment effectiveness using
      objective and subjective assessments to measure physical changes to the skin's microstructure
      and aesthetic skin features over time.

      A skin elasticity assessment using the Cutomer will be collected at Visits 1 (screening), 5
      (Day 90) and 6 (Day 180) to assess if any biomechanical changes of the skin occurred as a
      result of the ThermiRF treatment.

      Safety assessments will be collected using the Numerical Rating Scale (NRS) a 10-point scale,
      and adverse events reports (observed or reported).

      The overall study duration is approximately 12 months (i.e., 5-6 month recruitment period and
      6 month study visits).
    

Intervention name(s): Percutaneous Radiofrequency single treatment
Intervention type(s): Device
Intervention description(s): Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold.
Other intervention name(s): Thermi Percutaneous Radiofrequency Treatment; Hunsted Infusion on the treatment area; Thermal Camera; Ice packs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment