Lax Skin
Conditions
Keywords
Submental, Neck
Brief summary
This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure with the Renuvion APR Device to improve the appearance of lax tissue in the neck and submental region.
Detailed description
This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure to improve the appearance of lax tissue in the neck and submental region. All study subjects will be treated with the Renuvion APR Device. Phase I (n=17) of this study will be conducted primarily to provide safety data, however, effectiveness data will also be collected at the above stated timepoints through 6 months post-procedure. Phase II (n=65) of this study is the expansion of the study to a pivotal study.
Interventions
DEVICERenuvion APR Device
The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
Sponsors
Apyx Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female subjects 35-65 years of age (inclusive). 2. Healthy as determined by the investigator examining the subject. 3. Seeking improvement of the appearance of lax tissue in the neck and submental region. 4. Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation. 5. Willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, and returning for follow-up visits. 6. Willing to release rights for the use of study photos, including in potential publication. 7. Understands and accepts the obligation not to have significant weight loss or weight gain (≥8 pounds) post the treatment, and for the duration of participation in the study. 8. Willing to abstain from the use of blood thinners (including, but not limited to, Coumadin, NSAIDS, Ibuprofen, vitamin K, other) for 2 weeks (14 days) prior to the procedure. 9. Willing to abstain from smoking, vaping, or the use of e-cigarettes for 1 year prior to and for the entire duration of participation in the study. 10. Willing to abstain from the use of marijuana for 2 weeks prior to and for the duration of participation in the study. 11. Able to read, understand, sign and date the informed consent document (English only).
Exclusion criteria
1. Pregnant or lactating. 2. Pregnancy within 12 months prior to screening. 3. 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). 4. Allergy to tumescent anesthetic (lidocaine/epinephrine). 5. Excessive subcutaneous fat in the treatment area (as determined by the treating investigator). 6. Active systemic or local skin disease that may alter wound healing. 7. Significant or uncontrolled medical condition that, in the opinion of the investigator, participation in the study may compromise the patient's health. 8. Severe solar elastosis. 9. History of autoimmune disease (excluding Hashimoto's thyroiditis). 10. Known hypersensitivity or adverse reaction to anesthetics. 11. Known susceptibility to keloid formation or hypertrophic scarring. 12. Cancerous or pre-cancerous lesions in the area to be treated. 13. History or current diagnosis of cancer of any type (excluding skin cancer). 14. History of uncontrolled cardiovascular disease (i.e. myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other). 15. History, or current bleeding disorders (i.e. hemophilia or von Willebrand disease), or anticipated treatment with prescription anticoagulants. 16. Possesses a surgically implanted electronic device (i.e. pacemaker). 17. History of AIDs/HIV. 18. Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years. 19. Chronic hypoxia or dependence on supplemental oxygen. 20. Participation in any other investigational study within 30 days prior to consent. 21. Any surgical or transdermal neck/submental aesthetic procedures or plans to undergo any other aesthetic procedure during study participation. Such procedures include, but are not limited to, submentoplasty, liposuction, ultrasound, cryolipolysis, radiofrequency, and laser. 22. History of or current injury to the head and neck or any area of the body being treated as a part of this study. 23. Presence of more than mild platysmal banding as per the Geister, et al Validated Assessment Scale for Platysmal Bands. 24. Subject requiring removal of adipose tissue prior index procedure. 25. A family member of the investigator or sponsor; an employee of the investigator or sponsor. 26. Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Day 180 Number of Participants With Improvement Measured By Independent Photographic Review | 180-Day | Improvement in the appearance of lax tissue in the neck and submental region at 6 months as determined by qualitative 2D photography assessment by blinded Independent Photographic Reviewers. Three experienced, blinded photographic reviewers performed a qualitative analysis/review of the pre-treatment and post-treatment sets of images of each subject in a blinded and randomized order. Each blinded reviewer chose which image was the post-treatment image. Success was correct post-treatment image selection by at least 2 of the 3 reviewers. The percentage of subjects with a correct post-treatment image selection was calculated. |
| Subject Reported Pain - None to Moderate | Day 7 | The primary safety endpoint is the level of pain and discomfort after treatment as reported by the subject on an 11-point Numeric Rating Scale (NRS) through the 7-day follow-up visit where 0 is no pain and 10 is the most pain. Pain scores are classified as scores of 0 being no pain, 1 - 5 is minor pain, 6 - 7 is moderate pain, and 8 - 10 is severe pain. The primary safety objective is to demonstrate that the proportion of subjects with none-to- moderate pain exceeds the performance goal (PG). The performance goal is 55%. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Investigator Modified Global Aesthetics Improvement Scale (GAIS) | 90-Day | Investigator Modified GAIS:Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse |
| Investigator Modified Global Aesthetic Improvement Scale (GAIS) | 180-Day | Investigator Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse |
| Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | 180-Day | At 180 days post procedure, the subject's satisfaction with the procedure was assessed using a Patient Satisfaction Questionnaire. Questions were YES or NO questions pertaining to satisfaction with study treatment, observations of improvement, and considerations for recommendation. |
| Quantitative Improvement in Overall Lift of the Neck and Submental Area | 180-Day | Quantitative improvement in overall lift of the neck and submental area as determine by quantitative assessment based on 2D photography with Canfield Vectra system analysis. Fixed landmarks on the subject's face were used. |
| Day 90 Number of Participants With Improvement Measured By Independent Photographic Review | 90-Day | Change in the appearance of lax tissue in the neck and submental region at 90-days as determined by qualitative 2D photography assessment by blinded Independent Photographic Reviewers. Three experienced, blinded photographic reviewers performed a qualitative analysis/review of the pre-treatment and post-treatment sets of images of each subject in a blinded and randomized order. Each blinded reviewer chose which image was the post-treatment image. Success was correct post-treatment image selection by at least 2 of the 3 reviewers. The percentage of subjects with a correct post-treatment image selection was calculated. |
| Average Pain at Day 7 Reported by Subject | 7-Day | Level of pain and discomfort after treatment as reported by the subject on a 11-point Numeric Rating Scale where 0 is No Pain and 10 is Worst Possible Pain |
| Median Pain Reported by Subject at Day 7 | 7-Day | Level of pain and discomfort after treatment as reported by the subject on a 11-point Numeric Rating Scale where 0 is No Pain and 10 is Worst Possible Pain |
| Average Pain Reported by Subject at Day 30 | 30-Day | Level of pain and discomfort after treatment as reported by the subject on a 11-point Numeric Rating Scale where 0 is No Pain and 10 is Worst Possible Pain |
| Median Pain Reported by Subject at Day 30 | 30-Day | Level of pain and discomfort after treatment as reported by the subject on a 11-point Numeric Rating Scale where 0 is No Pain and 10 is Worst Possible Pain |
| Quantitative Improvement in Submental Volume | 180-Day | Quantitative improvement in submental volume at 180 days as determined by quantitative assessment based on 3D photography with Canfield Vectra system analysis. |
| Subject Modified Global Aesthetic Improvement Scale (GAIS) | 90-Day | Subject Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sub-Dermal Neck Renuvion APR Device - Study Phase I All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma. | 17 |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma. | 65 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Sub-Dermal Neck Renuvion APR Device - Study Phase I | Sub-Dermal Neck Renuvion APR Device - Study Phase II | Total |
|---|---|---|---|
| Age, Customized Average Age | 58.5 years STANDARD_DEVIATION 4 | 55.9 years STANDARD_DEVIATION 6.3 | 56.4 years STANDARD_DEVIATION 5.9 |
| Age, Customized Median Age | 59 years | 57.0 years | 57.0 years |
| Body Mass Index (BMI) | 25.5 kg/m^2 | 24.7 kg/m^2 | 25.5 kg/m^2 STANDARD_DEVIATION 4.7 |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Other: Greek Spanish | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 14 Participants | 61 Participants | 75 Participants |
| Region of Enrollment United States | 17 participants | 65 participants | 82 participants |
| Sex: Female, Male Female | 16 Participants | 59 Participants | 75 Participants |
| Sex: Female, Male Male | 1 Participants | 6 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 17 |
| other Total, other adverse events | 62 / 65 | 16 / 17 |
| serious Total, serious adverse events | 3 / 65 | 0 / 17 |
Outcome results
Primary
Day 180 Number of Participants With Improvement Measured By Independent Photographic Review
Improvement in the appearance of lax tissue in the neck and submental region at 6 months as determined by qualitative 2D photography assessment by blinded Independent Photographic Reviewers. Three experienced, blinded photographic reviewers performed a qualitative analysis/review of the pre-treatment and post-treatment sets of images of each subject in a blinded and randomized order. Each blinded reviewer chose which image was the post-treatment image. Success was correct post-treatment image selection by at least 2 of the 3 reviewers. The percentage of subjects with a correct post-treatment image selection was calculated.
Time frame: 180-Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Day 180 Number of Participants With Improvement Measured By Independent Photographic Review | 6 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Day 180 Number of Participants With Improvement Measured By Independent Photographic Review | 52 Participants |
p-value: <0.0001Fisher Exact
Primary
Subject Reported Pain - None to Moderate
The primary safety endpoint is the level of pain and discomfort after treatment as reported by the subject on an 11-point Numeric Rating Scale (NRS) through the 7-day follow-up visit where 0 is no pain and 10 is the most pain. Pain scores are classified as scores of 0 being no pain, 1 - 5 is minor pain, 6 - 7 is moderate pain, and 8 - 10 is severe pain. The primary safety objective is to demonstrate that the proportion of subjects with none-to- moderate pain exceeds the performance goal (PG). The performance goal is 55%.
Time frame: Day 7
Population: Phase I: 17 total participants started Phase I. 4 participants missed their Day 7 follow-up visit due to COVID-19 office closures and/or restrictions. Therefore, Day 7 data for Subject Reported Pain was only analyzed for 13 participants.~Phase II: 65 participants started Phase 2. 1 participant exited the study prior to Day 7 follow-up visit. Therefore, Day 7 data for Subject Reported Pain was only analyzed for 64 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Subject Reported Pain - None to Moderate | 13 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Subject Reported Pain - None to Moderate | 62 Participants |
Other Pre-specified
Average Pain at Day 7 Reported by Subject
Level of pain and discomfort after treatment as reported by the subject on a 11-point Numeric Rating Scale where 0 is No Pain and 10 is Worst Possible Pain
Time frame: 7-Day
Population: Phase I: 17 total participants started Phase I. 4 participants missed their D7 follow-up visit due to COVID-19 office closures and/or restrictions. Therefore, D7 Average Pain data was only available for 13 participants.~Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D7 visit . Therefore, Day 7 Average Pain data was only available for 64 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Average Pain at Day 7 Reported by Subject | 1.23 score on a scale | Standard Deviation 1.24 |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Average Pain at Day 7 Reported by Subject | 0.6 score on a scale | Standard Deviation 1.2 |
p-value: <0.0001Fisher Exact
Other Pre-specified
Average Pain Reported by Subject at Day 30
Level of pain and discomfort after treatment as reported by the subject on a 11-point Numeric Rating Scale where 0 is No Pain and 10 is Worst Possible Pain
Time frame: 30-Day
Population: Phase I: 17 total participants started Phase I. 2 participants missed their D30 follow-up visit due to COVID-19 office closures and/or restrictions. Therefore, D30 Average Pain data was only available for 15 participants.~Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D30 visit and1 participant was lost to follow-up prior to D30 visit. Therefore, Day 30 Average Pain data was only available for 63 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Average Pain Reported by Subject at Day 30 | 1.33 score on a scale | Standard Deviation 2.66 |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Average Pain Reported by Subject at Day 30 | 0.2 score on a scale | Standard Deviation 0.5 |
Other Pre-specified
Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure
At 180 days post procedure, the subject's satisfaction with the procedure was assessed using a Patient Satisfaction Questionnaire. Questions were YES or NO questions pertaining to satisfaction with study treatment, observations of improvement, and considerations for recommendation.
Time frame: 180-Day
Population: Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D180 visit and 2 participants was lost to follow-up prior to D180 Follow-up visit. Therefore, Day 180 Patient Satisfaction Questionnaire data was only available for 62 participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to Reduction in Jowls | NA Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to Reduction of Lines & Wrinkles in the Treatment Area | NA Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to More Jawline Definition | NA Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to Other Changes | NA Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to Improvement in Skin Texture in Treatment Area | NA Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to Would Recommend Procedure to a Friend | 12 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to Happy With Results of Procedure | 12 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to Would Consider Having the Procedure on Another Body Area | 11 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to Reduction in the Area Under the Chin | NA Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to Would Consider Having the Procedure on Another Body Area | 47 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to Reduction in Jowls | 20 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to Happy With Results of Procedure | 47 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to Improvement in Skin Texture in Treatment Area | 20 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to Reduction in the Area Under the Chin | 41 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to Reduction of Lines & Wrinkles in the Treatment Area | 21 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to Other Changes | 10 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to Would Recommend Procedure to a Friend | 46 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | Number of Subjects that Answered YES to More Jawline Definition | 39 Participants |
Other Pre-specified
Day 90 Number of Participants With Improvement Measured By Independent Photographic Review
Change in the appearance of lax tissue in the neck and submental region at 90-days as determined by qualitative 2D photography assessment by blinded Independent Photographic Reviewers. Three experienced, blinded photographic reviewers performed a qualitative analysis/review of the pre-treatment and post-treatment sets of images of each subject in a blinded and randomized order. Each blinded reviewer chose which image was the post-treatment image. Success was correct post-treatment image selection by at least 2 of the 3 reviewers. The percentage of subjects with a correct post-treatment image selection was calculated.
Time frame: 90-Day
Population: Phase I: 17 total participants started Phase I. 7 participants missed their D90 images due to COVID-19 office closures and/or restrictions. Therefore, D90 Independent Photographic Review data was only available for 10 participants.~Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D90 visit and 1 participant was lost to follow-up prior to D90 Follow-up visit. Therefore, Day 90 Independent Photographic Review data was only available for 63 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Day 90 Number of Participants With Improvement Measured By Independent Photographic Review | 8 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Day 90 Number of Participants With Improvement Measured By Independent Photographic Review | 48 Participants |
p-value: <0.0004Fisher Exact
Other Pre-specified
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Investigator Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time frame: 180-Day
Population: Phase-II discrepancy is due to 1 subject exited due to an AE during treatment and 2 subject lost to follow-up prior to Day 180 visit. Which brought the numbers to: Phase-II 62
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | No Change | 3 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | Much Improved | 6 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | Improved | 5 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | Much Worse | 0 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | Worse | 1 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | Very Much Worse | 0 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | Very Much Improved | 2 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | Very Much Worse | 0 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | Very Much Improved | 8 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | Improved | 27 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | No Change | 6 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | Worse | 2 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | Much Improved | 19 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | Much Worse | 0 Participants |
Other Pre-specified
Investigator Modified Global Aesthetics Improvement Scale (GAIS)
Investigator Modified GAIS:Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time frame: 90-Day
Population: Phase I: 17 total participants started Phase I. 2 participants completed virtual visits and 1 participant missed their D90 visit due to COVID-19 office closures and/or restrictions. Therefore, D90 Investigator GAIS data was only available for 14 participants.~Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D90 visit and 1 participant was lost to follow-up prior to D90 visit. Therefore, Day 90 Investigator GAIS data was only available for 63 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Investigator Modified Global Aesthetics Improvement Scale (GAIS) | Improved | 8 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Investigator Modified Global Aesthetics Improvement Scale (GAIS) | No Change | 2 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Investigator Modified Global Aesthetics Improvement Scale (GAIS) | Worse | 1 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Investigator Modified Global Aesthetics Improvement Scale (GAIS) | Much Worse | 0 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Investigator Modified Global Aesthetics Improvement Scale (GAIS) | Very Much Worse | 0 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Investigator Modified Global Aesthetics Improvement Scale (GAIS) | Very Much Improved | 0 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Investigator Modified Global Aesthetics Improvement Scale (GAIS) | Much Improved | 3 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Investigator Modified Global Aesthetics Improvement Scale (GAIS) | Improved | 33 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Investigator Modified Global Aesthetics Improvement Scale (GAIS) | Very Much Worse | 0 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Investigator Modified Global Aesthetics Improvement Scale (GAIS) | No Change | 3 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Investigator Modified Global Aesthetics Improvement Scale (GAIS) | Much Improved | 19 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Investigator Modified Global Aesthetics Improvement Scale (GAIS) | Worse | 0 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Investigator Modified Global Aesthetics Improvement Scale (GAIS) | Very Much Improved | 8 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Investigator Modified Global Aesthetics Improvement Scale (GAIS) | Much Worse | 0 Participants |
Other Pre-specified
Median Pain Reported by Subject at Day 30
Level of pain and discomfort after treatment as reported by the subject on a 11-point Numeric Rating Scale where 0 is No Pain and 10 is Worst Possible Pain
Time frame: 30-Day
Population: Phase I: 17 total participants started Phase I. 2 participants missed their D30 follow-up visit due to COVID-19 office closures and/or restrictions. Therefore, D30 Median Pain data was only available for 15 participants.~Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D30 visit and1 participant was lost to follow-up prior to D30 visit. Therefore, Day 30 Median Pain data was only available for 63 participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Median Pain Reported by Subject at Day 30 | 0 score on a scale |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Median Pain Reported by Subject at Day 30 | 0.0 score on a scale |
Other Pre-specified
Median Pain Reported by Subject at Day 7
Level of pain and discomfort after treatment as reported by the subject on a 11-point Numeric Rating Scale where 0 is No Pain and 10 is Worst Possible Pain
Time frame: 7-Day
Population: Phase I: 17 total participants started Phase I. 4 participants missed their D7 follow-up visit due to COVID-19 office closures and/or restrictions. Therefore, D7 Median Pain data was only available for 13 participants.~Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D7 visit . Therefore, Day 7 Median Pain data was only available for 64 participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Median Pain Reported by Subject at Day 7 | 1.0 score on a scale |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Median Pain Reported by Subject at Day 7 | 0.0 score on a scale |
Other Pre-specified
Quantitative Improvement in Overall Lift of the Neck and Submental Area
Quantitative improvement in overall lift of the neck and submental area as determine by quantitative assessment based on 2D photography with Canfield Vectra system analysis. Fixed landmarks on the subject's face were used.
Time frame: 180-Day
Population: Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D180 visit, 1 participant completed a virtual visit, and 2 participants were lost to follow-up prior to D180 Follow-up visit. Therefore, Day 180 Quantitative Improvement data was only available for 61 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Quantitative Improvement in Overall Lift of the Neck and Submental Area | 38 Participants |
Other Pre-specified
Quantitative Improvement in Submental Volume
Quantitative improvement in submental volume at 180 days as determined by quantitative assessment based on 3D photography with Canfield Vectra system analysis.
Time frame: 180-Day
Population: Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D180 visit, 2 participants were lost to follow-up prior to D180 visit, 1 participant completed a virtual visit for D180 and did not have photographs for volume assessment, and 1 subject had poor image quality that resulted in the inability to assess volume change. Therefore, Day 180 Quantitative Improvement in Submental Volume was only available for 60 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Quantitative Improvement in Submental Volume | 41 Participants |
Other Pre-specified
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Subject Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time frame: 90-Day
Population: Phase I: 17 total participants started Phase I. 1 participant missed their D90 Modified GAIS due to COVID-19 office closures and/or restrictions. Therefore, D90 Subject Modified GAIS data was only available for 16 participants.~Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D90 visit and 1 participant was lost to follow-up prior to D90 Follow-up visit. Therefore, Day 90 Subject Modified GAIS data was only available for 63 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Improved | 5 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Worse | 0 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Very Much Improved | 0 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Much Worse | 0 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Much Improved | 7 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Very Much Worse | 1 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Subject Modified Global Aesthetic Improvement Scale (GAIS) | No Change | 3 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Very Much Worse | 0 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Much Improved | 18 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Improved | 33 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Subject Modified Global Aesthetic Improvement Scale (GAIS) | No Change | 3 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Worse | 1 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Much Worse | 1 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Very Much Improved | 7 Participants |
Other Pre-specified
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Subject Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time frame: 180-Day
Population: Phase-II discrepancy is due to 1 subject exited due to an AE during treatment and 2 subject lost to follow-up prior to Day 180 visit. Which brought the numbers to: Phase-II 62
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Very Much Improved | 4 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Worse | 1 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Subject Modified Global Aesthetic Improvement Scale (GAIS) | No Change | 3 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Much Worse | 0 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Much Improved | 5 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Very Much Worse | 1 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase I | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Improved | 3 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Very Much Worse | 0 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Improved | 24 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Subject Modified Global Aesthetic Improvement Scale (GAIS) | No Change | 7 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Very Much Improved | 12 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Much Improved | 17 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Worse | 2 Participants |
| Sub-Dermal Neck Renuvion APR Device - Study Phase II | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Much Worse | 0 Participants |