Safety and Effectiveness Evaluation of the Device in Achieving Submental Lift

ThermiGen, LLC72 enrolled

Overview

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.

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).

Interventions

Percutaneous Radiofrequency single treatmentDEVICE

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.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female between the age of 35 and 65 inclusive; * Mild to Moderate Skin Laxity Severity on the submental area defined as: "normal" muscle, "mild to moderate" skin laxity and "mild to moderate" fat; * Desire to improve jawline definitions and/or submental skin lift * Body mass index (BMI) ≤30; * Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation. * Cooperative, reliable, and able to read and comprehend English; * Able to read, understand, sign and date the informed consent document (English only); * Able and willing to comply with the schedule visit(s) and study requirements. Exclusion Criteria: * Excessive subcutaneous fat on the submental area * Use within 24 hours preceding surgery of ibuprofen, acetaminophen, any other analgesics, anti-inflammatory products, or any products including herbals and supplements that could interfere with the clinical assessments of this study (other than drugs used for anesthesia); * History of cosmetic treatments on the face and neck including but not limited to: facial skin tightening procedures within the past year, injectable fillers of any type, Botox on the lower face, ablative resurfacing laser treatment, none ablative, rejuvenative laser or light treatment within the past six months, deep facial peels, dermabrasion, face lift, neck lift, blepharoplasty or brow lift, contour threads or other. * History or current injury to the Head and Neck. * Severe solar elastosis * Clinically significant facial wounds, lesions or acute infections including cystic acne, dermatitis, lupus or other immunodeficiency affecting the dermis * Presence of metal stents or facial implants * Pregnant or planning pregnancy prior to the end of study participation * Current or past history of smoking * History or current diagnosis of cancer of any type * History of uncontrolled cardiovascular disease(i.e. myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other) * Known hypersensitivity to local anesthetic medications * History, or current bleeding disorders (i.e. hemophilia or von Willebrand disease), or anticipated treatment with prescription anticoagulants * Possesses a surgically implanted electronic device (i.e. pacemaker) * History of AIDs/HIV * Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years * Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirement and/or record the necessary study measurements * A family member of the investigator or an employee of the investigator. * Participation in any other investigational study within 30 days prior to consent;

Outcomes

Primary Outcomes

Tissue Lift at the Submental Area Measuring >/= 20 mm2

A \>/= 20 mm\^2 change from baseline at Day 90 as measured quantitatively using 3D photo images (a calculation).

Time frame: Change from baseline at Day 90

Secondary Outcomes

Percent of Participants Rated as Improved or Not Improved as Scored by the Blinded Rater/Reviewer

Overall improvement of submental lift was determined by a blinded rater panel using before and after photos

Time frame: Change from baseline to Days 90 and 180

Physician Global Aesthetic Improvement Scale (P-GAIS)

A subjective assessment of overall improvement measured by the physician using the PGAIS where the physician rates the appearance of the treated area (submental area) with respect to lift compared to baseline photography at the defined time points. The 5-point scale measures from "Very much improved" to "worse".

Time frame: Change from baseline at Days 90 and 180

Subject Global Aesthetic Improvement Scale (S-GAIS)

A subjective assessment of overall improvement measured by the participant using the SGAIS where the participant rates the appearance of the treated area (submental area) with respect to "lift"is measured from. the 5-point scale measures from Very much improved to worse.

Time frame: Change from baseline at Days 90 and 180

Physician Global Satisfaction Questionnaire (P-GSQ)

A subjective assessment of global satisfaction as measured by the physician using the P-GSQ where the physician rates his/her level of satisfaction of the treatment and treated area based on 4 satisfaction questions respective to 1. changes to the treated area, 2. skin texture of the treated area, 3. satisfaction with treatment results and 4. likelihood to recommend the treatment as a treatment option.

Time frame: Change from baseline at Days 90 and 180

Subject Global Satisfaction Questionnaire (S-GSQ)

A subjective assessment of global satisfaction as measured by the participant using the S-GSQ where the participant rates his/her level of satisfaction of the treatment and treated area based on 4 satisfaction questions respective to 1. changes to the treated area, 2. skin texture of the treated area, 3. satisfaction with treatment results and 4. likelihood to recommend the treatment as a treatment option.

Time frame: Change from baseline at Days 90 and 180

Safety and Effectiveness Evaluation of the Device in Achieving Submental Lift

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes