Collagen Degeneration, Collagen Shrinkage, Skin Laxity, Tissue Breakdown, Tissue Degeneration
Conditions
Brief summary
The goal of this prospective, single-arm clinical study is to gather quantifiable data on Renuvion's impact on skin elasticity and hydration, indicators of skin quality and estimate the biological skin age using DNA methylation in males and females between 18 and 75 years of age who plan to receive a lower facelift surgery. The main purpose is to quantify the effect of the Renuvion device on skin elasticity (collagen density, elastin, fibrillin-1), hydration (aquaporin-3, acidic glycosaminoglycans, HA), and DNA methylation to estimate the biological age of the skin. Participants will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System.
Detailed description
The purpose of this study is to gather quantifiable data on Renuvion's impact on skin elasticity and hydration, indicators of skin quality and estimate the biological skin age using DNA methylation. This study is a prospective, single-arm clinical study to be conducted at up to three clinical sites in the US. Up to 10 subjects will be enrolled and treated if they meet the inclusion/exclusion criteria and provide written informed consent. Enrolled subjects meeting all entrance criteria and confirmed eligible for study treatment will be asked to participate. Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System. The mid/upper-face area will not be treated with Renuvion and the lower face/neck area will be treated with Renuvion. Treatment will consist of subdermal coagulation of soft tissue using the Renuvion APR handpiece.
Interventions
DEVICERenuvion APR System
The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
Sponsors
Apyx Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective single-arm, study of up to 10 study subjects undergoing a lower facelift surgery and treatment with the Renuvion APR System. The study will be conducted at up to three (3) investigational centers in the United States. Two biopsy tissue samples will be taken during the facelift procedure prior to use of the Renuvion APR System and then at the Day 180 visit. Tissue samples will be assessed via microscopy, histology, and immunohistochemistry for biological markers of elasticity (collagen density, elastin, fibrillin-1) and hydration (\[aquaporin-3, acidic glycosaminoglycans (GAGs), HA\]). Additionally, DNA methylation will be measured in tissue samples to estimate the biological age of the skin. Follow-up will occur 1 day, 2 days (optional), 7 days, 14 days, 45 days, 90 days, and 180 days post-procedure with images and skin quality measurements taken as described.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects, ages 18 - 75 years old. * ASA Physical Status Classification System Class I and Class II subjects. * Planning to undergo a lower facelift procedure, with or without a neck lift, at the investigator's site. * Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation. * Absence of physical conditions unacceptable to the investigator. * Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation. * Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits. * Willing to release rights for the use of study photos, including in publication. * Able to read, understand, sign, and date the informed consent. * Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit.
Exclusion criteria
* Subjects presenting with ASA Physical Status Classification System Classes III or higher. * Pregnant, lactating, or plans to become pregnant during study participation. * Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine). * Known hypersensitivity or allergy to ibuprofen or other NSAIDS. * Active systemic or local skin disease that may alter wound healing. * Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health. * History of autoimmune disease (excluding Hashimoto's thyroiditis). * Known susceptibility to keloid formation or hypertrophic scarring. * Cancerous or pre-cancerous lesions in the area to be treated. * Possesses a surgically implanted electronic device (i.e. pacemaker). * Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years. * Participation in any other investigational study within 30 days prior to consent and throughout study participation. * Subject who, in the opinion of the investigator, is not an appropriate candidate for the study. * Subject who has had a prior facelift, neck lift, or Renuvion treatment in the face/neck area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of Elasticity (Collagen & Elastin) | Baseline, Day 180 | To assess Elasticity (collagen \& elastin) evaluation will be based on the qualitative histology in samples at baseline and Day 180 follow-up. Two samples from each time period were analyses - control and treatment area. The H\&E, trichrome, and van Gieson-stained slides were evaluated via light microscopy for any abnormalities and extracellular matrix changes. The results of histopathological assessment were scored using the industry standard 5-point scoring system. 0=Normal, 1=Minimal, 2=Mild, 3=Moderate, 4=Severe. |
| Analyzing Days of Duration for Bruising, Swelling | Post-Treatment, Day 1, 7, 14, 45, 90, 180 | Analysis days of duration of overall facial bruising and swelling post-treatment through the 180-day visit. The reported data is for the lower face treatment area only; the control area was not evaluated for bruising/swelling. |
| Percentage of Lower Face Area Healed | Post-Treatment, Day 1, 7, 14, 45, 90, 180 | Percentage of the lower facial treatment area assessed as healed at each post-treatment time frame (Days 1, 7, 14, 45, 90 \& 180) based on investigator clinical evaluation documented in Case Report Forms. The reported data is for the lower face treatment area only; the control untreated mid/upper-face area was not evaluated for healing. |
| Bleeding | During Procedure (Day 0) | Analysis of bleeding during surgery measured in cubic centimeter. The reported data is for the lower face treatment area only; the control area was not evaluated for bleeding. |
| The Principal Investigator Will Complete a PGAIS Assessing Overall Aesthetic Improvement in the Treatment Area at Day 180 Post-treatment. | Day 180 | Global Aesthetic Improvement Scale Evaluation (PGAIS) rating by investigator \[Very much improved, Much improved, Improved, No change, Worse, Much Worse, Very much Worse\]. The reported data is for the lower face treatment area only; the control area was not evaluated for GAIS as it was not treated. |
| The Subject Will Complete a SGAIS Assessing Overall Aesthetic Improvement in the Treatment Area at Day 180 Post-treatment. | Day 180 | Subject Global Aesthetic Improvement Scale Evaluation (SGAIS) rating by subject \[Very much improved, Much improved, Improved, No change, Worse, Much Worse, Very much Worse\]. The reported data is for the lower face treatment area only; the control area was not evaluated for GAIS as it was not treated. |
| Patient Satisfaction | Day 180 | The subject will complete a Patient Satisfaction Questionnaire (PSQ) while referring to their image in a mirror and current post-treatment photos compared to baseline photos to rate how satisfied they are, and if they note any improvement in the treatment area. The reported data is for the lower face treatment area only; the control area was not evaluated for PSQ as it was not treated. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Holcomb, M.D.
Holcomb & Kreithen Plastic Surgery and MedSpa
PRINCIPAL_INVESTIGATORMelinda Lacerna, M.D.
LA Plastic Surgery & Dermatology
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 7 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
None listed