Histological Evaluation of Human Skin Bx to Assess the Effects of APR Tx as an Adjunct Procedure in Facelift Surgery

Apyx Medical7 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Analysis of Elasticity (collagen density, elastin, & fibrillin-1)

To assess Elasticity (collagen density, elastin, \& fibrillin-1) evaluation will be based on the qualitative microscopic observation of the stained sections comparing baseline samples to follow-up samples. Histology and immunohistochemistry (IHC) part of the study will be assessed semi-quantitatively. Thus, there will not be units of measurement e.g., weight and height for these evaluations. Semi-quantitative scoring for any microscopic changes (H\&E staining) and enhancing collagen production (e.g., trichrome staining). Four-point Severity Scale Semi-Quantitative Grading of Changes in Histology Samples Description - Definition Normal - Tissue is considered to be normal Minimal - The amount of change present barely exceeds normal limits. Mild (Slight) - The amount of change is easily identified but limited severity. Moderate - The amount of change is prominent, but significant potential for increased severity. Severe - The degree of change is as complete as possible

Time frame: Baseline, Day 180

Analysis of Hydration (aquaporin-3, acidic glycosaminoglycans (GAGs), hyaluronic acid (HA))

To assess Hydration (aquaporin-3, GAGs, HA), evaluation will be based on the qualitative microscopic observation of the stained sections comparing baseline samples to follow-up samples. Histology and immunohistochemistry (IHC) part of the study will be assessed semi-quantitatively. Thus, there will not be units of measurement e.g., weight and height for these kinds of evaluations. Semi-quantitative scoring for any microscopic changes (H\&E staining) and enhancing collagen production (e.g., trichrome staining). Four-point Severity Scale Semi-Quantitative Grading of Changes in Histology Samples Description - Definition Normal - Tissue is considered to be normal Minimal - The amount of change present barely exceeds normal limits. Mild (Slight) - The amount of change is easily identified but limited severity. Moderate - The amount of change is prominent, but significant potential for increased severity. Severe - The degree of change is as complete as possible

Time frame: Baseline, Day 180

Analysis of Adverse Events

Analysis of adverse events through the 180-day post-treatment visit.

Time frame: Treatment, Day 1, 7, 14, 45, 90, 180

Analyzing days of duration for Bruising, Swelling

Analysis days of duration of bruising and swelling post-treatment through the 180-day visit.

Time frame: Post-Treatment, Day 1, 7, 14, 45, 90, 180

Days to healed percentage

Analysis average number of days to healed profile post-procedure through the 180-day post-treatment visit through Case Report Forms through percentage healed at each follow-up.

Time frame: Post-Treatment, Day 1, 7, 14, 45, 90, 180

Bleeding

Analysis of bleeding during surgery measured in cubic centimeter.

Time frame: During Procedure (Day 0)

The Principal Investigator will complete a PGAIS assessing overall aesthetic improvement in the treatment area at day 45, 90, and 180 post-treatment.

Global Aesthetic Improvement Scale Evaluation (PGAIS) rating by investigator \[Very much improved, Much improved, Improved, No change, Worse, Much Worse, Very much Worse\]

Time frame: Day 45, 90 and180

The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area at day 45, 90, and 180 post-treatment.

Subject Global Aesthetic Improvement Scale Evaluation (SGAIS) rating by subject \[Very much improved, Much improved, Improved, No change, Worse, Much Worse, Very much Worse\]

Time frame: Day 45, 90 and180

Patient Satisfaction

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.

Time frame: Day 180

Estimated biological age by DNA methylation.

DNA methylation (DNAm) will be used to measure the tissue samples to estimate the biological age of the skin. A highly accurate skin-specific age algorithm will analyze these modifications related to human skin health and molecular aging - quantifying the skin health/skin age of the tissue beyond the chronological age of the subject. Hallmarks of aging include genomic instability, telomere attrition, epigenetic alterations, loss of proteostasis, deregulated nutrient sensing, mitochondrial dysfunction, cellular senescence, stem cell exhaustion, and altered intercellular communication.

Time frame: Baseline, Day 180

Histological Evaluation of Human Skin Bx to Assess the Effects of APR Tx as an Adjunct Procedure in Facelift Surgery

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes