Safety and Effectiveness Evaluation of the Device in Achieving Submental Lift
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|ClinicalTrials.gov Identifier: NCT02832674|
Recruitment Status : Completed
First Posted : July 14, 2016
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Skin Laxity||Device: Percutaneous Radiofrequency single treatment||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single-Center, Single-Treatment, Safety and Effectiveness Evaluation of Percutaneous Radiofrequency in Achieving Submental Lift|
|Actual Study Start Date :||June 25, 2016|
|Actual Primary Completion Date :||February 20, 2017|
|Actual Study Completion Date :||April 8, 2017|
Experimental: Single Treatment
All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'
Device: Percutaneous Radiofrequency single treatment
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.
- Tissue Lift at the Submental Area Measuring >/= 20 mm2 [ Time Frame: Change from baseline at Day 90 ]A >/= 20 mm^2 change from baseline at Day 90 as measured quantitatively using 3D photo images (a calculation).
- Percent of Participants Rated as Improved or Not Improved as Scored by the Blinded Rater/Reviewer [ Time Frame: Change from baseline to Days 90 and 180 ]Overall improvement of submental lift was determined by a blinded rater panel using before and after photos
- Physician Global Aesthetic Improvement Scale (P-GAIS) [ Time Frame: Change from baseline at Days 90 and 180 ]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".
- Subject Global Aesthetic Improvement Scale (S-GAIS) [ Time Frame: Change from baseline at Days 90 and 180 ]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.
- Physician Global Satisfaction Questionnaire (P-GSQ) [ Time Frame: Change from baseline at Days 90 and 180 ]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.
- Subject Global Satisfaction Questionnaire (S-GSQ) [ Time Frame: Change from baseline at Days 90 and 180 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832674
|United States, New Jersey|
|New Jersey Plastic Surgery|
|Montclair, New Jersey, United States, 07042|
|Principal Investigator:||Barry DiBernardo, MD||New Jersey Plastic Surgery|
|Study Director:||Toni Fournier||ThermiGen, LLC|
|Study Chair:||Kevin O'Brien||ThermiGen, LLC|