Renuvion for Loose Skin

Recruiting at 1 trial location

Overseen By Crystal A Snyder, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Apyx Medical

Must not be taking: NSAIDs

Disqualifiers: Pregnancy, Autoimmune disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

David Holcomb, M.D.

Principal Investigator

Holcomb & Kreithen Plastic Surgery and MedSpa

Melinda Lacerna, M.D.

Principal Investigator

LA Plastic Surgery & Dermatology

Eligibility Criteria

This trial is for men and women aged 18-75 planning to have a lower facelift surgery. It's designed to assess the effects of the Renuvion APR System on skin quality, specifically elasticity and hydration, as well as estimating biological skin age.

Inclusion Criteria

I am in good or mild systemic disease health according to the ASA classification.

I plan to have a lower facelift, possibly including a neck lift, at the specified location.

I am willing to use birth control during the study.

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a lower facelift surgery and treatment with the Renuvion APR System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of skin elasticity, hydration, and biological age estimation

180 days

Multiple visits (Day 1, 7, 14, 45, 90, 180)

Treatment Details

Interventions

• Renuvion APR System

Trial Overview The study tests the Renuvion APR System's impact on improving skin conditions like Cutis Laxa and Collagen Degeneration by measuring changes in collagen density, elastin levels, hydration factors, and DNA methylation after its use during facelift surgery.

Participant Groups

Group I: Procedure with the Renuvion APR System in lower facelift area Experimental Treatment 1 Intervention

Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System.

Who Is Running the Clinical Trial?

Apyx Medical

Lead Sponsor

Trials

10

Recruited

360+