Clinical trial NCT06243744: Histological Evaluation of Human Skin Bx to Assess the Effects of APR Tx as an Adjunct Procedure in Facelift Surgery
Official title: Histological Evaluation of Human Skin Biopsies to Assess the Effects of Renuvion APR Treatment as an Adjunct Procedure in Facelift Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Skin Laxity
Tissue Degeneration
Tissue Breakdown
Collagen Degeneration
Collagen Shrinkage
Lead sponsor: Apyx Medical
Sponsor class: INDUSTRY
First posted: 2024-02-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Analysis of Elasticity (collagen density, elastin, & fibrillin-1)
timeFrame: Baseline, Day 180
measure: Analysis of Hydration (aquaporin-3, acidic glycosaminoglycans (GAGs), hyaluronic acid (HA))
timeFrame: Baseline, Day 180
measure: Analysis of Adverse Events
timeFrame: Treatment, Day 1, 7, 14, 45, 90, 180
measure: Analyzing days of duration for Bruising, Swelling
timeFrame: Post-Treatment, Day 1, 7, 14, 45, 90, 180
measure: Days to healed percentage
timeFrame: Post-Treatment, Day 1, 7, 14, 45, 90, 180
measure: Bleeding
timeFrame: During Procedure (Day 0)
measure: The Principal Investigator will complete a PGAIS assessing overall aesthetic improvement in the treatment area at day 45, 90, and 180 post-treatment.
timeFrame: Day 45, 90 and180
measure: The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area at day 45, 90, and 180 post-treatment.
timeFrame: Day 45, 90 and180
measure: Patient Satisfaction
timeFrame: Day 180
measure: Estimated biological age by DNA methylation.
timeFrame: Baseline, Day 180
Secondary outcomes:
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: LA Plastic Surgery and Dermatology
state: Florida
city: Sarasota
country: United States
facility: Holcomb & Kreithen Plastic Surgery and MedSpa
state: Florida
Study officials:
affiliation: Holcomb & Kreithen Plastic Surgery and MedSpa
name: David Holcomb, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: LA Plastic Surgery & Dermatology
name: Melinda Lacerna, M.D.
role: PRINCIPAL_INVESTIGATOR
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