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Procedure with the Renuvion APR System in lower facelift area for Collagen Atrophy

N/A

Recruiting

Led By David Holcomb, M.D.

Research Sponsored by Apyx Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ASA Physical Status Classification System Class I and Class II subjects

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment, day 1, 7, 14, 45, 90, 180

Awards & highlights

Study Summary

This trial aims to study the effects of Renuvion on skin quality and aging in individuals aged 18 to 75 undergoing lower facelift surgery. The study will measure changes in skin elasticity

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical risks associated with surgical procedures such as infection, scarring, tissue necrosis or adverse reactions to the Renuvion APR treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment, day 1, 7, 14, 45, 90, 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~treatment, day 1, 7, 14, 45, 90, 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment, day 1, 7, 14, 45, 90, 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Analysis of Adverse Events

Analysis of Elasticity (collagen density, elastin, & fibrillin-1)

Analysis of Hydration (aquaporin-3, acidic glycosaminoglycans (GAGs), hyaluronic acid (HA))

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Procedure with the Renuvion APR System in lower facelift areaExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Renuvion APR System

2021

N/A

~30

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Apyx MedicalLead Sponsor

9 Previous Clinical Trials

348 Total Patients Enrolled

David Holcomb, M.D.Principal InvestigatorHolcomb & Kreithen Plastic Surgery and MedSpa

Melinda Lacerna, M.D.Principal InvestigatorLA Plastic Surgery & Dermatology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current cumulative count of individuals participating in this clinical investigation?

"Indeed, data from clinicaltrials.gov confirms that this current medical trial is actively seeking volunteers. The trial was initially published on November 30th, 2023 and underwent the last update on February 5th, 2024. Recruitment aims to enroll a total of 10 participants distributed across two distinct sites."

Answered by AI

Is it possible for me to participate in this ongoing medical study?

"To be considered for enrollment in this research study, individuals should exhibit lax skin and fall within the age range of 18 to 75 years. The trial aims to include approximately 10 participants."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"As per clinicaltrials.gov, this research study is actively seeking volunteers. The trial was initially listed on 11/30/2023 and last modified on 2/5/2024."

Answered by AI