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

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Description

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

Start Date
November 30, 2023
Completion Date
December 31, 2024
Enrollment
10
Date Posted
February 6, 2024
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
LA Plastic Surgery and Dermatology
Bradenton, Florida 34208, United States

Holcomb & Kreithen Plastic Surgery and MedSpa
Sarasota, Florida 34237, United States

Eligibility

Minimum Age (years)
18
Maximum Age (years)
75
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.

Study Contact Info

Study Contact Name
Kari A Larson, MBA; Crystal A Snyder, CCRP
Study Contact Phone

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
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.
NCTid (if applicable)
NCT06243744