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

March 20, 2026 updated by: Apyx Medical

Histological Evaluation of Human Skin Biopsies to Assess the Effects of Renuvion APR Treatment as an Adjunct Procedure in Facelift Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Bradenton, Florida, United States, 34208
        • LA Plastic Surgery and Dermatology
      • Sarasota, Florida, United States, 34237
        • Holcomb & Kreithen Plastic Surgery and MedSpa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Procedure with the Renuvion APR System in lower facelift area
Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System.
Device: Renuvion 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of Elasticity (Collagen & Elastin)
Time Frame: 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.
Baseline, Day 180
Analyzing Days of Duration for Bruising, Swelling
Time Frame: 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.
Post-Treatment, Day 1, 7, 14, 45, 90, 180
Percentage of Lower Face Area Healed
Time Frame: 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.
Post-Treatment, Day 1, 7, 14, 45, 90, 180
Bleeding
Time Frame: 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.
During Procedure (Day 0)
The Principal Investigator Will Complete a PGAIS Assessing Overall Aesthetic Improvement in the Treatment Area at Day 180 Post-treatment.
Time Frame: 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.
Day 180
The Subject Will Complete a SGAIS Assessing Overall Aesthetic Improvement in the Treatment Area at Day 180 Post-treatment.
Time Frame: 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.
Day 180
Patient Satisfaction
Time Frame: 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.
Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apyx Medical

Investigators

  • Principal Investigator: David Holcomb, M.D., Holcomb & Kreithen Plastic Surgery and MedSpa
  • Principal Investigator: Melinda Lacerna, M.D., LA Plastic Surgery & Dermatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2023

Primary Completion (Actual)

July 10, 2025

Study Completion (Actual)

July 10, 2025

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APX-21-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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