An interventional study of Percutaneous Radiofrequency single treatment in Skin Laxity, sponsored by ThermiGen, LLC. Completed at 1 site in United States. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-01.
Sponsored by ThermiGen, LLC · Not applicable, Interventional, and Treatment
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:
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).
147 studies on the registry are indexed under Cutis Laxa; 35 are open to participants now.
This study's enrollment of 72 is above the median of 30 across 129 interventional studies indexed under Cutis Laxa.
Browse Cutis Laxa studies →ThermiGen, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: Thermi Percutaneous Radiofrequency Treatment, Hunsted Infusion on the treatment area, Thermal Camera, Ice packs
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
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
One hundred and twenty-one subjects were screened and 72 were enrolled. study initiation 25Jun2015.
| Milestone | Single Treatment |
|---|---|
| Started | 72 |
| Completed | 67 |
| Not completed | 5 |
A \>/= 20 mm\^2 change from baseline at Day 90 as measured quantitatively using 3D photo images (a calculation).
| percentage of participants | Single Treatment |
|---|---|
| Tissue Lift at the Submental Area Measuring >/= 20 mm2 | 56.9 (46.6 to 66.9) |
Overall improvement of submental lift was determined by a blinded rater panel using before and after photos
| percentage of participants | Single Treatment |
|---|---|
| Improvement Day 90 = Yes | 74.2 (62 to 84.2) |
| Improvement Day 90 = No | 25.8 (15.8 to 38) |
| Improvement Day 180 = Yes | 71.4 (57.8 to 82.7) |
| Improvement Day 180 = No | 28.6 (17.3 to 42.2) |
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".
| percentage of participants | Single Treatment |
|---|---|
| Improvement Day 90 = Yes | 94.2 (85.8 to 98.4) |
| Improvement Day 90 = No | 5.8 (1.6 to 14.2) |
| Improvement Day 180 = Yes | 89.6 (79.7 to 95.7) |
| Improvement Day 180 = No | 10.4 (4.3 to 20.3) |
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.
| percentage of participants | Single Treatment |
|---|---|
| Improvement Day 90 = Yes | 89.9 (80.2 to 95.8) |
| Improvement Day 90 = No | 10.1 (4.2 to 19.8) |
| Improvement Day 180 = Yes | 83.6 (72.5 to 91.5) |
| Improvement Day 180 = No | 16.4 (8.5 to 27.5) |
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.
| percentage of participants | Single Treatment |
|---|---|
| Improvement Day 90 = Yes | 92.8 (83.9 to 97.6) |
| Improvement Day 90 = No | 7.2 (2.4 to 16.1) |
| Improvement Day 180 = Yes | 91 (81.5 to 96.6) |
| Improvement Day 180 = No | 9 (3.4 to 18.5) |
| Satisfaction Day 90 = Yes | 81.2 (69.9 to 89.6) |
| Satisfaction Day 90 = No | 18.8 (10.4 to 30.1) |
| Satisfaction Day 180 = Yes | 71.6 (59.3 to 82) |
| Satisfaction Day 180 = No | 28.4 (18 to 40.7) |
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.
| percentage of participants | Single Treatment |
|---|---|
| Improvement Day 90 = Yes | 88.4 (78.4 to 94.9) |
| Improvement Day 90 = No | 11.6 (5.1 to 21.6) |
| Improvement Day 180 = Yes | 83.6 (72.5 to 91.5) |
| Improvement Day 180 = No | 16.4 (8.5 to 27.5) |
| Satisfaction Day 90 = Yes | 68.1 (55.8 to 78.8) |
| Satisfaction Day 90 = No | 31.9 (21.2 to 44.1) |
| Satisfaction Day 180 = Yes | 65.7 (53.1 to 76.8) |
| Satisfaction Day 180 = No | 34.3 (23.2 to 46.9) |
Collected over Adverse Events were collected from the time the subject signed the informed consent to last subject last visit. Duration was approximately 1.25 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Treatment | 0/72 (0%) | 1/72 (1.4%) | 32/72 (44.4%) |
| Event | Single Treatment |
|---|---|
| Retropharyngeal Swelling/FluidRespiratory, thoracic and mediastinal disorders | 1/72 |
| Event | Single Treatment |
|---|---|
| Application Site HypoaesthesiaGeneral disorders | 22/72 |
| Application Site EdemaGeneral disorders | 16/72 |
| Application Site SwellingGeneral disorders | 8/72 |
| Application Site PainGastrointestinal disorders | 7/72 |
| Age, Continuous(years) | Single Treatment |
|---|---|
| Mean | 52.9 ± 7.0 |
| Sex: Female, Male(Participants) | Single Treatment |
|---|---|
| Female | 64 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Single Treatment |
|---|---|
| Hispanic or Latino | 20 |
| Not Hispanic or Latino | 46 |
| Unknown or Not Reported | 6 |
| Race (NIH/OMB)(Participants) | Single Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 55 |
| More than one race | 1 |
| Unknown or Not Reported | 14 |
| Body Mass Index(kg/m^2) | Single Treatment |
|---|---|
| Mean | 26.1 ± 2.9 |
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