Rhytides, Wrinkle
Conditions
Brief summary
This is a multi-center, single arm, evaluator-blind prospective study of up to 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides.
Detailed description
This is a multi-center, single arm, evaluator-blind prospective study of up to 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides. All study subjects will be treated with the Renuvion Dermal System. The study population will consist of males and females, 30 years of age or older, requesting a procedure for the purpose of improving facial appearance by reducing facial wrinkles and rhytides. Those subjects who meet eligibility criteria and agree to provide written informed consent will be invited to participate.
Interventions
DEVICERenuvion Dermal System
The Renuvion® Dermal System consists of an electrosurgical generator unit, a handpiece with detachable standoffs, and a supply of helium gas. Radio Frequency (RF) energy is delivered to the handpiece by the electrosurgical generator unit and used to energize an electrode. When helium gas is passed over the energized electrode, a helium plasma is generated which allows for conduction of the RF energy from the electrode to the subject in the form of a precise helium plasma beam.
Sponsors
Apyx Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female subjects ≥30 years of age. 2. Subject is seeking improvement of facial appearance by reducing facial wrinkles and rhytides. 3. Subject with a facial wrinkle score rating of at least 4 on the FWS. 4. Subject with a Fitzpatrick Skin Scale score ≤III. 5. Subjects who are willing and able to take protocol allowed medications prescribed at investigator discretion which may include Keflex or Z-pack as an antibiotic, Acyclovir or Valtrex as an antiviral, Diflucan as an antifungal, Ativan or Valium for anxiety during treatment, Norco or Ultram for pain control during or post-procedure, Gabapentin, Tylenol with Codeine or NSAIDS for post-procedure pain control, and/or Antihistamines for itching during healing. 6. Subjects who are willing to have polycarbonate eye shields placed for study treatment. 7. Subject is willing and able to provide written informed consent. 8. Subject is willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, post-care instructions, and returning for follow-up visits. 9. Subject is willing to maintain baseline skin care regimen during study participation with the exception when protocol specified ointments, moisturizers, and cleansers are required during healing stage (through approximately the 30-day follow-up). Sunblock is required throughout the study starting on approximately day 10. 10. Subject is willing to release rights to study Sponsor for the use of the photos, including in potential publication. 11. Subject is willing to abstain from other facial cosmetic procedures through the 6-month follow-up visit; examples include, but are not limited to, laser or chemical re-surfacing, dermabrasion, neuromodulator and/or filler injections, aesthetic facial surgery, etc.
Exclusion criteria
1. Subject with a Fitzpatrick Skin Scale score ≥IV. 2. Subject is pregnant or lactating. 3. Active HSV-1 or diabetes mellitus. 4. Active cut, wound, or infection on the skin of the face. 5. Subject has used, within 30 days prior to screening or plans to use during study participation, Accutane, Retinol, or any medication that can cause dermal hypersensitivity. 6. Subject has used, within 10 days prior to study treatment, aspirin or NSAIDs. 7. Subject has a history of autoimmune disease (excluding Hashimoto's thyroiditis). 8. Subject with a known bleeding disorder or who is on blood thinning medication that may be at risk for bleeding. 9. Subject has a known adverse reaction to lidocaine and/or epinephrine. 10. Subjects with active skin disease of the facial area or known connective tissue disease. 11. Subjects with known susceptibility to keloid formation or hypertrophic scarring. 12. Subjects with present cancerous or pre-cancerous lesions in the area to be treated. 13. Subject who, for any reason, suspects that they will not be able to complete the prescribed follow-up assessment(s). 14. Subject has had concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety and effectiveness of the study treatment method. 15. Subject is not willing to release rights to study Sponsor for the use of the photos, including in potential publication. 16. Subject is enrolled in another investigational (drug or device) clinical trial that can interfere with this study's assessments. 17. Subject has undergone a facelift procedure within 12 months prior to the screening visit. 18. Subject has received IPL, microneedling, or chemical peels within 3 months prior to the screening visit. 19. Subject has received microneedling with RF or any facial treatment with an energy-based device within 6 months prior to the screening visit. 20. Subject has received facial injections with BOTOX® or other toxins within 6 months prior to the screening visit. 21. Subject has received hyaluronic acid or calcium hydroxylapatite fillers within 4 months prior to the screening visit. 22. Subject who is a family member or employee of the investigator or sponsor. 23. Participation in any other investigational study within 30 days prior to consent. 24. Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Independent Photo Reviewer Fitzpatrick Wrinkle and Elastosis Scale (FWS) | 90-day | The FWS is a clinically validated assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, where the lower the value, the better the outcome. Three Independent Photographic Reviewers were blinded to the study subject's visit (Day 90 follow-up visit) and performed photographic assessments of each subject's wrinkle depth in the treated zones. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Investigator Fitzpatrick Wrinkle and Elastosis Scale | Baseline, 90-day Change, 180-day Change | Magnitude of improvement measured by the mean change in FWS from baseline, 90-day, 180-day visit as determined by Investigators. Scale ranges from 1 (no wrinkles) to 9 (most wrinkles). |
| Subject Global Aesthetic Improvement Scale | 90-day | Subject rated GAIS: Very much improved, much improved, improved, no change, worse, much worse, very much worse |
| Investigator Global Aesthetic Improvement Scale | 90-day | Investigator rated GAIS: Very much improved, much improved, improved, no change, worse, much worse, very much worse |
| Independent Photographic Reviewer Masked Assessment | 90-day | At least 2 out of 3 blinded Independent Photographic Reviewers (IPRs) correctly identify the 90-day image of a subject from the pair of baseline and 90-day images. |
| Pain and Discomfort | Baseline to Day 10 | Evaluation of the change in pain and discomfort after treatment (baseline, within 60 minutes following the procedure) as reported by the subject on a visual analog scale (VAS)experienced in the period up to the 10-day follow-up visit. Any pain or discomfort will be recorded daily by each participant in a diary using an 11-point Visual Analogue Scale (VAS) where 0 is no pain and 10 is most pain. |
| Percentage of Subjects With Achievement of Re-Epithelialization | 10-day, 30-day, 90-day | Achievement of re-epithelialization by facial zone and across all facial zones as reported by the investigator. |
| Comfortable in Public | 10-day | Mean duration until study subject feels comfortable going in public after treatment as reported by the study subject. Willing to go out in public by the 10-day visit. |
| Patient Satisfaction Questionnaire | 90-day | 5 questions pertaining to satisfaction with results, would you recommend to a friend, would you have the procedure done again, any changes noticed, and any improvement in quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Full-face Renuvion Dermal System Treatment Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass. | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Full-face Renuvion Dermal System Treatment |
|---|---|
| Age, Customized Adults 30 yrs of age or older who signed informed consent and who met inclusion/exclusion criteria. | 64.5 years STANDARD_DEVIATION 7 |
| Body Mass Index (BMI) | 25.1 kg/m^2 STANDARD_DEVIATION 4 |
| Fitzpatrick Skin Type Scale (FST) Type I | 4 Participants |
| Fitzpatrick Skin Type Scale (FST) Type II | 38 Participants |
| Fitzpatrick Skin Type Scale (FST) Type III | 13 Participants |
| Fitzpatrick Wrinkle and Elastosis Scale (FWS) Class III: Score 7 | 12 Participants |
| Fitzpatrick Wrinkle and Elastosis Scale (FWS) Class III: Score 8 | 19 Participants |
| Fitzpatrick Wrinkle and Elastosis Scale (FWS) Class III: Score 9 | 9 Participants |
| Fitzpatrick Wrinkle and Elastosis Scale (FWS) Class II: Score 5 | 1 Participants |
| Fitzpatrick Wrinkle and Elastosis Scale (FWS) Class II: Score 6 | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 55 Participants |
| Region of Enrollment United States | 55 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 55 / 55 |
| serious Total, serious adverse events | 1 / 55 |
Outcome results
Primary
Independent Photo Reviewer Fitzpatrick Wrinkle and Elastosis Scale (FWS)
The FWS is a clinically validated assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, where the lower the value, the better the outcome. Three Independent Photographic Reviewers were blinded to the study subject's visit (Day 90 follow-up visit) and performed photographic assessments of each subject's wrinkle depth in the treated zones.
Time frame: 90-day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full-face Renuvion Dermal System Treatment | Independent Photo Reviewer Fitzpatrick Wrinkle and Elastosis Scale (FWS) | 55 Participants |
p-value: <0.0001Fisher Exact
Other Pre-specified
Comfortable in Public
Mean duration until study subject feels comfortable going in public after treatment as reported by the study subject. Willing to go out in public by the 10-day visit.
Time frame: 10-day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full-face Renuvion Dermal System Treatment | Comfortable in Public | 28 Participants |
Other Pre-specified
Independent Photographic Reviewer Masked Assessment
At least 2 out of 3 blinded Independent Photographic Reviewers (IPRs) correctly identify the 90-day image of a subject from the pair of baseline and 90-day images.
Time frame: 90-day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full-face Renuvion Dermal System Treatment | Independent Photographic Reviewer Masked Assessment | 55 Participants |
Other Pre-specified
Investigator Fitzpatrick Wrinkle and Elastosis Scale
Magnitude of improvement measured by the mean change in FWS from baseline, 90-day, 180-day visit as determined by Investigators. Scale ranges from 1 (no wrinkles) to 9 (most wrinkles).
Time frame: Baseline, 90-day Change, 180-day Change
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Full-face Renuvion Dermal System Treatment | Investigator Fitzpatrick Wrinkle and Elastosis Scale | Baseline | 7.4 score on a scale | Standard Deviation 1.1 |
| Full-face Renuvion Dermal System Treatment | Investigator Fitzpatrick Wrinkle and Elastosis Scale | 90 Day Change | -4.4 score on a scale | Standard Deviation 1.8 |
| Full-face Renuvion Dermal System Treatment | Investigator Fitzpatrick Wrinkle and Elastosis Scale | 180 Day Change | -4.4 score on a scale | Standard Deviation 2 |
Other Pre-specified
Investigator Global Aesthetic Improvement Scale
Investigator rated GAIS: Very much improved, much improved, improved, no change, worse, much worse, very much worse
Time frame: 90-day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full-face Renuvion Dermal System Treatment | Investigator Global Aesthetic Improvement Scale | Improved | 2 Participants |
| Full-face Renuvion Dermal System Treatment | Investigator Global Aesthetic Improvement Scale | Worse | 0 Participants |
| Full-face Renuvion Dermal System Treatment | Investigator Global Aesthetic Improvement Scale | Much Worse | 0 Participants |
| Full-face Renuvion Dermal System Treatment | Investigator Global Aesthetic Improvement Scale | Very Much Worse | 0 Participants |
| Full-face Renuvion Dermal System Treatment | Investigator Global Aesthetic Improvement Scale | Very Much Improved | 36 Participants |
| Full-face Renuvion Dermal System Treatment | Investigator Global Aesthetic Improvement Scale | Much Improved | 17 Participants |
Other Pre-specified
Pain and Discomfort
Evaluation of the change in pain and discomfort after treatment (baseline, within 60 minutes following the procedure) as reported by the subject on a visual analog scale (VAS)experienced in the period up to the 10-day follow-up visit. Any pain or discomfort will be recorded daily by each participant in a diary using an 11-point Visual Analogue Scale (VAS) where 0 is no pain and 10 is most pain.
Time frame: Baseline to Day 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Full-face Renuvion Dermal System Treatment | Pain and Discomfort | Baseline | 0.0 score on a scale | Standard Deviation 0 |
| Full-face Renuvion Dermal System Treatment | Pain and Discomfort | Post-Procedure | 3.7 score on a scale | Standard Deviation 2.8 |
| Full-face Renuvion Dermal System Treatment | Pain and Discomfort | 1 Day | 2.4 score on a scale | Standard Deviation 2.6 |
| Full-face Renuvion Dermal System Treatment | Pain and Discomfort | 6 Day | 2.9 score on a scale | Standard Deviation 2.6 |
| Full-face Renuvion Dermal System Treatment | Pain and Discomfort | 10 Day | 1.1 score on a scale | Standard Deviation 1.6 |
Other Pre-specified
Patient Satisfaction Questionnaire
5 questions pertaining to satisfaction with results, would you recommend to a friend, would you have the procedure done again, any changes noticed, and any improvement in quality of life.
Time frame: 90-day
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full-face Renuvion Dermal System Treatment | Patient Satisfaction Questionnaire | Happy With Results of Procedure | 53 Participants |
| Full-face Renuvion Dermal System Treatment | Patient Satisfaction Questionnaire | Which Changes do You See in the Area Treated: None | 0 Participants |
| Full-face Renuvion Dermal System Treatment | Patient Satisfaction Questionnaire | Skin Texture Improvement | 52 Participants |
| Full-face Renuvion Dermal System Treatment | Patient Satisfaction Questionnaire | Skin Tone Improvement | 47 Participants |
| Full-face Renuvion Dermal System Treatment | Patient Satisfaction Questionnaire | Skin Pigmentation Improvement | 36 Participants |
| Full-face Renuvion Dermal System Treatment | Patient Satisfaction Questionnaire | Fine Lines and Wrinkles Improvement | 50 Participants |
| Full-face Renuvion Dermal System Treatment | Patient Satisfaction Questionnaire | Skin Pore Size Improvement | 40 Participants |
| Full-face Renuvion Dermal System Treatment | Patient Satisfaction Questionnaire | Skin Feels Better | 44 Participants |
| Full-face Renuvion Dermal System Treatment | Patient Satisfaction Questionnaire | Skin Feels Tighter | 51 Participants |
| Full-face Renuvion Dermal System Treatment | Patient Satisfaction Questionnaire | Skin Appears Brighter | 38 Participants |
| Full-face Renuvion Dermal System Treatment | Patient Satisfaction Questionnaire | Skin Seems More Youthful | 50 Participants |
| Full-face Renuvion Dermal System Treatment | Patient Satisfaction Questionnaire | Other Changes Noted | 6 Participants |
| Full-face Renuvion Dermal System Treatment | Patient Satisfaction Questionnaire | Would Recommend Procedure to a Friend | 46 Participants |
| Full-face Renuvion Dermal System Treatment | Patient Satisfaction Questionnaire | Would Consider Having the Procedure Performed Again | 35 Participants |
| Full-face Renuvion Dermal System Treatment | Patient Satisfaction Questionnaire | Skin Looks Tighter | 52 Participants |
| Full-face Renuvion Dermal System Treatment | Patient Satisfaction Questionnaire | Skin Looks More Radiant | 41 Participants |
Other Pre-specified
Percentage of Subjects With Achievement of Re-Epithelialization
Achievement of re-epithelialization by facial zone and across all facial zones as reported by the investigator.
Time frame: 10-day, 30-day, 90-day
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full-face Renuvion Dermal System Treatment | Percentage of Subjects With Achievement of Re-Epithelialization | 10 Day | 3 Participants |
| Full-face Renuvion Dermal System Treatment | Percentage of Subjects With Achievement of Re-Epithelialization | 30 Day | 48 Participants |
| Full-face Renuvion Dermal System Treatment | Percentage of Subjects With Achievement of Re-Epithelialization | 90 Day | 55 Participants |
Other Pre-specified
Subject Global Aesthetic Improvement Scale
Subject rated GAIS: Very much improved, much improved, improved, no change, worse, much worse, very much worse
Time frame: 90-day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full-face Renuvion Dermal System Treatment | Subject Global Aesthetic Improvement Scale | No Change | 2 Participants |
| Full-face Renuvion Dermal System Treatment | Subject Global Aesthetic Improvement Scale | Worse | 0 Participants |
| Full-face Renuvion Dermal System Treatment | Subject Global Aesthetic Improvement Scale | Very Much Improved | 27 Participants |
| Full-face Renuvion Dermal System Treatment | Subject Global Aesthetic Improvement Scale | Much Improved | 21 Participants |
| Full-face Renuvion Dermal System Treatment | Subject Global Aesthetic Improvement Scale | Improved | 5 Participants |
| Full-face Renuvion Dermal System Treatment | Subject Global Aesthetic Improvement Scale | Much Worse | 0 Participants |
| Full-face Renuvion Dermal System Treatment | Subject Global Aesthetic Improvement Scale | Very Much Worse | 0 Participants |