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Completed

NCT Number: NCT06243744

Histological Evaluation of Human Skin Bx to Assess the Effects of APR Tx 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.

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Key information

Conditions

Skin Laxity Collagen Degeneration Collagen Shrinkage Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Tissue Breakdown Tissue Degeneration

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LA Plastic Surgery and Dermatology, Bradenton, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renuvion APR System

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Apyx Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2024
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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