Skin LaxityNCT06243744

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

A study testing Renuvion APR System in people with Skin Laxity and Tissue Degeneration, run by Apyx Medical at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Skin Laxity, Tissue Degeneration, Tissue Breakdown
What is being tested?: Renuvion APR System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 2 sitesUnited States
Study dates: 30 Nov 2023to 10 Jul 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Show all 10Show fewer

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.

Who cannot join

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.

Show all 14Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

LA Plastic Surgery and Dermatology
Bradenton, Florida, 34208
Holcomb & Kreithen Plastic Surgery and MedSpa
Sarasota, Florida, 34237

Other trials in United States

About this study

Official title: Histological Evaluation of Human Skin Biopsies to Assess the Effects of Renuvion APR Treatment as an Adjunct Procedure in Facelift Surgery

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.

Read the 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.

Conditions: Skin Laxity, Tissue Degeneration, Tissue Breakdown, Collagen Degeneration, Collagen Shrinkage
Being tested: Renuvion APR System
Medical subject headings: Cutis Laxa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Renuvion APR SystemDevice
The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.

Study groups in NCT06243744
Study group	Role	What they receive
Procedure with the Renuvion APR System in lower facelift area	Other	Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System. Receives: Device: Renuvion APR System

What is being measured

The primary outcome is the main question the study is designed to answer.

Analysis of Elasticity (Collagen & Elastin)
To assess Elasticity (collagen \& elastin) evaluation will be based on the qualitative histology in samples at baseline and Day 180 follow-up. Two samples from each time period were analyses - control and treatment area. The H\&E, trichrome, and van Gieson-stained slides were evaluated via light microscopy for any abnormalities and extracellular matrix changes. The results of histopathological assessment were scored using the industry standard 5-point scoring system. 0=Normal, 1=Minimal, 2=Mild, 3=Moderate, 4=Severe.
Measured: Baseline, Day 180
Analyzing Days of Duration for Bruising, Swelling
Analysis days of duration of overall facial bruising and swelling post-treatment through the 180-day visit. The reported data is for the lower face treatment area only; the control area was not evaluated for bruising/swelling.
Measured: Post-Treatment, Day 1, 7, 14, 45, 90, 180
Percentage of Lower Face Area Healed
Percentage of the lower facial treatment area assessed as healed at each post-treatment time frame (Days 1, 7, 14, 45, 90 \& 180) based on investigator clinical evaluation documented in Case Report Forms. The reported data is for the lower face treatment area only; the control untreated mid/upper-face area was not evaluated for healing.
Measured: Post-Treatment, Day 1, 7, 14, 45, 90, 180
Bleeding
Analysis of bleeding during surgery measured in cubic centimeter. The reported data is for the lower face treatment area only; the control area was not evaluated for bleeding.
Measured: During Procedure (Day 0)
The Principal Investigator Will Complete a PGAIS Assessing Overall Aesthetic Improvement in the Treatment Area at Day 180 Post-treatment.
Global Aesthetic Improvement Scale Evaluation (PGAIS) rating by investigator [Very much improved, Much improved, Improved, No change, Worse, Much Worse, Very much Worse]. The reported data is for the lower face treatment area only; the control area was not evaluated for GAIS as it was not treated.
Measured: Day 180
The Subject Will Complete a SGAIS Assessing Overall Aesthetic Improvement in the Treatment Area at Day 180 Post-treatment.
Subject Global Aesthetic Improvement Scale Evaluation (SGAIS) rating by subject [Very much improved, Much improved, Improved, No change, Worse, Much Worse, Very much Worse]. The reported data is for the lower face treatment area only; the control area was not evaluated for GAIS as it was not treated.
Measured: Day 180
Patient Satisfaction
The subject will complete a Patient Satisfaction Questionnaire (PSQ) while referring to their image in a mirror and current post-treatment photos compared to baseline photos to rate how satisfied they are, and if they note any improvement in the treatment area. The reported data is for the lower face treatment area only; the control area was not evaluated for PSQ as it was not treated.
Measured: Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 202310 Jul 2025

First posted6 Feb 2024
Study start30 Nov 2023
Primary completion10 Jul 2025
Study completion10 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Skin LaxityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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.
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06243744
Sponsor's protocol ID: APX-21-04
Status last verified: Mar 2026
First submitted: 18 Dec 2023
Last updated: 24 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Goldberg SN, Gazelle GS, Halpern EF, Rittman WJ, Mueller PR, Rosenthal DI. Radiofrequency tissue ablation: importance of local temperature along the electrode tip exposure in determining lesion shape and size. Acad Radiol. 1996 Mar;3(3):212-8. doi: 10.1016/s1076-6332(96)80443-0.
PubMed 8796667
Thomsen S. Pathologic analysis of photothermal and photomechanical effects of laser-tissue interactions. Photochem Photobiol. 1991 Jun;53(6):825-35. doi: 10.1111/j.1751-1097.1991.tb09897.x.
PubMed 1886941
Ross EV, McKinlay JR, Anderson RR. Why does carbon dioxide resurfacing work? A review. Arch Dermatol. 1999 Apr;135(4):444-54. doi: 10.1001/archderm.135.4.444.
PubMed 10206052
Gardner ES, Reinisch L, Stricklin GP, Ellis DL. In vitro changes in non-facial human skin following CO2 laser resurfacing: a comparison study. Lasers Surg Med. 1996;19(4):379-87. doi: 10.1002/(SICI)1096-9101(1996)19:43.0.CO;2-P.
PubMed 8982996
Doshi SN, Alster TS. Combination radiofrequency and diode laser for treatment of facial rhytides and skin laxity. J Cosmet Laser Ther. 2005 Mar;7(1):11-5. doi: 10.1080/14764170410003075.
PubMed 16020210
Fatemi A, Weiss MA, Weiss RA. Short-term histologic effects of nonablative resurfacing: results with a dynamically cooled millisecond-domain 1320 nm Nd:YAG laser. Dermatol Surg. 2002 Feb;28(2):172-6. doi: 10.1046/j.1524-4725.2002.01112.x.
PubMed 11860431
Mayoral FA. Skin tightening with a combined unipolar and bipolar radiofrequency device. J Drugs Dermatol. 2007 Feb;6(2):212-5.
PubMed 17373181
Alster TS, Doshi SN, Hopping SB. Combination surgical lifting with ablative laser skin resurfacing of facial skin: a retrospective analysis. Dermatol Surg. 2004 Sep;30(9):1191-5. doi: 10.1111/j.1524-4725.2004.30370.x.
PubMed 15355357
Zelickson BD, Kist D, Bernstein E, Brown DB, Ksenzenko S, Burns J, Kilmer S, Mehregan D, Pope K. Histological and ultrastructural evaluation of the effects of a radiofrequency-based nonablative dermal remodeling device: a pilot study. Arch Dermatol. 2004 Feb;140(2):204-9. doi: 10.1001/archderm.140.2.204.
PubMed 14967794
Hsu TS, Kaminer MS. The use of nonablative radiofrequency technology to tighten the lower face and neck. Semin Cutan Med Surg. 2003 Jun;22(2):115-23. doi: 10.1053/sder.2003.50011.
PubMed 12877230
Paul M, Blugerman G, Kreindel M, Mulholland RS. Three-dimensional radiofrequency tissue tightening: a proposed mechanism and applications for body contouring. Aesthetic Plast Surg. 2011 Feb;35(1):87-95. doi: 10.1007/s00266-010-9564-0. Epub 2010 Sep 11.
PubMed 20835826
Hurwitz D, Smith D. Treatment of overweight patients by radiofrequency-assisted liposuction (RFAL) for aesthetic reshaping and skin tightening. Aesthetic Plast Surg. 2012 Feb;36(1):62-71. doi: 10.1007/s00266-011-9783-z. Epub 2011 Jul 13.
PubMed 21751063
Irvine Duncan D. Nonexcisional tissue tightening: creating skin surface area reduction during abdominal liposuction by adding radiofrequency heating. Aesthet Surg J. 2013 Nov 1;33(8):1154-66. doi: 10.1177/1090820X13505862.
PubMed 24335016
Boeni R. Safety of tumescent liposuction under local anesthesia in a series of 4,380 patients. Dermatology. 2011;222(3):278-81. doi: 10.1159/000327375. Epub 2011 May 24.
PubMed 21606638
Nakab L, Hee CK, Guetta O. Improvements in Skin Quality Biological Markers in Skin Explants Using Hyaluronic Acid Filler VYC-12L. Plast Reconstr Surg Glob Open. 2020 Mar 27;8(3):e2723. doi: 10.1097/GOX.0000000000002723. eCollection 2020 Mar.
PubMed 32537370

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Histological Evaluation of Human Skin Biopsies to Assess the Effects of Renuvion APR Treatment as an Adjunct Procedure in Facelift Surgery
ClinicalTrials.gov ID: NCT06243744
Acronym / sponsor ID: APX-21-04
Conditions: Skin Laxity, Tissue Degeneration, Tissue Breakdown, Collagen Degeneration, Collagen Shrinkage
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Apyx MedicalIndustry (pharma, biotech, devices)
Study start: 30 Nov 2023 (actual)
Primary completion: 10 Jul 2025 (actual)
Study completion: 10 Jul 2025 (actual)
First posted: 6 Feb 2024 (actual)
Results: Posted 24 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Procedure with the Renuvion APR System in lower facelift area	Other	Device: Renuvion APR SystemSubjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Renuvion APR SystemThe Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.	Device	Procedure with the Renuvion APR System in lower facelift area

Primary outcome

Analysis of Elasticity (Collagen & Elastin)
Time frame: Baseline, Day 180
To assess Elasticity (collagen \& elastin) evaluation will be based on the qualitative histology in samples at baseline and Day 180 follow-up. Two samples from each time period were analyses - control and treatment area. The H\&E, trichrome, and van Gieson-stained slides were evaluated via light microscopy for any abnormalities and extracellular matrix changes. The results of histopathological assessment were scored using the industry standard 5-point scoring system. 0=Normal, 1=Minimal, 2=Mild, 3=Moderate, 4=Severe.
Analyzing Days of Duration for Bruising, Swelling
Time frame: Post-Treatment, Day 1, 7, 14, 45, 90, 180
Analysis days of duration of overall facial bruising and swelling post-treatment through the 180-day visit. The reported data is for the lower face treatment area only; the control area was not evaluated for bruising/swelling.
Percentage of Lower Face Area Healed
Time frame: Post-Treatment, Day 1, 7, 14, 45, 90, 180
Percentage of the lower facial treatment area assessed as healed at each post-treatment time frame (Days 1, 7, 14, 45, 90 \& 180) based on investigator clinical evaluation documented in Case Report Forms. The reported data is for the lower face treatment area only; the control untreated mid/upper-face area was not evaluated for healing.
Bleeding
Time frame: During Procedure (Day 0)
Analysis of bleeding during surgery measured in cubic centimeter. The reported data is for the lower face treatment area only; the control area was not evaluated for bleeding.
The Principal Investigator Will Complete a PGAIS Assessing Overall Aesthetic Improvement in the Treatment Area at Day 180 Post-treatment.
Time frame: Day 180
Global Aesthetic Improvement Scale Evaluation (PGAIS) rating by investigator [Very much improved, Much improved, Improved, No change, Worse, Much Worse, Very much Worse]. The reported data is for the lower face treatment area only; the control area was not evaluated for GAIS as it was not treated.
The Subject Will Complete a SGAIS Assessing Overall Aesthetic Improvement in the Treatment Area at Day 180 Post-treatment.
Time frame: Day 180
Subject Global Aesthetic Improvement Scale Evaluation (SGAIS) rating by subject [Very much improved, Much improved, Improved, No change, Worse, Much Worse, Very much Worse]. The reported data is for the lower face treatment area only; the control area was not evaluated for GAIS as it was not treated.
Patient Satisfaction
Time frame: Day 180
The subject will complete a Patient Satisfaction Questionnaire (PSQ) while referring to their image in a mirror and current post-treatment photos compared to baseline photos to rate how satisfied they are, and if they note any improvement in the treatment area. The reported data is for the lower face treatment area only; the control area was not evaluated for PSQ as it was not treated.

Results and safety

Results posted to the registry on 24 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Renuvion APR System (Lower Face)	7	6
Untreated Control (Mid/Upper Face)	7	6

Primary outcome: Analysis of Elasticity (Collagen & Elastin)

Time frame: Baseline, Day 180. Mean (Full Range). Unit: units on a scale

Measure	Treatment Area n = 7	Control n = 7
Histological Findings Collagen Deposition Baseline	1.7 (0 to 4)	0.5 (0 to 4)
Histological Findings Collagen Deposition D180	1.5 (0 to 4)	0.5 (0 to 4)
Histological Findings Elastin Density Baseline	2.3 (2 to 3)	2.2 (2 to 3)
Histological Findings Elastin Density D180	3 (2 to 4)	2.3 (2 to 4)

Primary outcome: Analyzing Days of Duration for Bruising, Swelling

Time frame: Post-Treatment, Day 1, 7, 14, 45, 90, 180. Number. Unit: participants

Measure	Procedure With the Renuvion APR System in Lower Facelift Area n = 7
With Brusing D1	6
With Bruising D7	5
With Bruising D14	5
With Bruising D45	0
With Bruising D90	0
With Bruising D180	0
With Swelling D1	7
With Swelling D7	7

Primary outcome: Percentage of Lower Face Area Healed

Time frame: Post-Treatment, Day 1, 7, 14, 45, 90, 180. Mean (Standard Deviation). Unit: percentage of lower facial area healed

Measure	Procedure With the Renuvion APR System in Lower Facelift Area n = 7
D1	17.5 (16.6)
D7	40.0 (28.9)
D14	47.5 (28.9)
D45	70.8 (17.4)
D90	92.1 (6.4)
D180	99.8 (0.4)

Primary outcome: Bleeding

Time frame: During Procedure (Day 0). Count of participants. Unit: Participants

Measure	Procedure With the Renuvion APR System in Lower Facelift Area n = 7
15cc Blood Loss	2
20cc Blood Loss	2
70cc Blood Loss	1
75cc Blood Loss	1
300cc Blood Loss	1

Adverse events

Time frame: Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Procedure With the Renuvion APR System in Lower Facelift Area	0 of 7 (0%)	7 of 7 (100%)	0 of 7
Untreated Control (Upper Face)	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8796667Goldberg SN, Gazelle GS, Halpern EF, Rittman WJ, Mueller PR, Rosenthal DI. Radiofrequency tissue ablation: importance of local temperature along the electrode tip exposure in determining lesion shape and size. Acad Radiol. 1996 Mar;3(3):212-8. doi: 10.1016/s1076-6332(96)80443-0.
Background: PubMed 1886941Thomsen S. Pathologic analysis of photothermal and photomechanical effects of laser-tissue interactions. Photochem Photobiol. 1991 Jun;53(6):825-35. doi: 10.1111/j.1751-1097.1991.tb09897.x.
Background: PubMed 10206052Ross EV, McKinlay JR, Anderson RR. Why does carbon dioxide resurfacing work? A review. Arch Dermatol. 1999 Apr;135(4):444-54. doi: 10.1001/archderm.135.4.444.
Background: PubMed 8982996Gardner ES, Reinisch L, Stricklin GP, Ellis DL. In vitro changes in non-facial human skin following CO2 laser resurfacing: a comparison study. Lasers Surg Med. 1996;19(4):379-87. doi: 10.1002/(SICI)1096-9101(1996)19:43.0.CO;2-P.
Background: PubMed 16020210Doshi SN, Alster TS. Combination radiofrequency and diode laser for treatment of facial rhytides and skin laxity. J Cosmet Laser Ther. 2005 Mar;7(1):11-5. doi: 10.1080/14764170410003075.
Background: PubMed 11860431Fatemi A, Weiss MA, Weiss RA. Short-term histologic effects of nonablative resurfacing: results with a dynamically cooled millisecond-domain 1320 nm Nd:YAG laser. Dermatol Surg. 2002 Feb;28(2):172-6. doi: 10.1046/j.1524-4725.2002.01112.x.
Background: PubMed 17373181Mayoral FA. Skin tightening with a combined unipolar and bipolar radiofrequency device. J Drugs Dermatol. 2007 Feb;6(2):212-5.
Background: PubMed 15355357Alster TS, Doshi SN, Hopping SB. Combination surgical lifting with ablative laser skin resurfacing of facial skin: a retrospective analysis. Dermatol Surg. 2004 Sep;30(9):1191-5. doi: 10.1111/j.1524-4725.2004.30370.x.
Background: PubMed 14967794Zelickson BD, Kist D, Bernstein E, Brown DB, Ksenzenko S, Burns J, Kilmer S, Mehregan D, Pope K. Histological and ultrastructural evaluation of the effects of a radiofrequency-based nonablative dermal remodeling device: a pilot study. Arch Dermatol. 2004 Feb;140(2):204-9. doi: 10.1001/archderm.140.2.204.
Background: PubMed 12877230Hsu TS, Kaminer MS. The use of nonablative radiofrequency technology to tighten the lower face and neck. Semin Cutan Med Surg. 2003 Jun;22(2):115-23. doi: 10.1053/sder.2003.50011.
Background: PubMed 20835826Paul M, Blugerman G, Kreindel M, Mulholland RS. Three-dimensional radiofrequency tissue tightening: a proposed mechanism and applications for body contouring. Aesthetic Plast Surg. 2011 Feb;35(1):87-95. doi: 10.1007/s00266-010-9564-0. Epub 2010 Sep 11.
Background: PubMed 21751063Hurwitz D, Smith D. Treatment of overweight patients by radiofrequency-assisted liposuction (RFAL) for aesthetic reshaping and skin tightening. Aesthetic Plast Surg. 2012 Feb;36(1):62-71. doi: 10.1007/s00266-011-9783-z. Epub 2011 Jul 13.
Ulthera White Paper. Lower Face, Submentum, and NeckLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Holcomb, M.D. principal investigator

Holcomb & Kreithen Plastic Surgery and MedSpa

Melinda Lacerna, M.D. principal investigator

LA Plastic Surgery & Dermatology

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Renuvion APR System in people with Skin Laxity and Tissue Degeneration, run by Apyx Medical at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analysis of Elasticity (Collagen & Elastin) (time frame: Baseline, Day 180). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06243744, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.