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Renuvion for Loose Skin

N/A
Waitlist Available
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
Must not have
Subjects presenting with ASA Physical Status Classification System Classes III or higher
Active systemic or local skin disease that may alter wound healing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment, day 1, 7, 14, 45, 90, 180
Awards & highlights
No Placebo-Only Group

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My health is severely impacted by my disease.
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I have a skin condition that could affect healing.
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I have cancerous or pre-cancerous spots where treatment is planned.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~60

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
~0 spots leftby Nov 2024
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