An interventional study of Renuvion APR System in Skin Laxity, Tissue Degeneration and Tissue Breakdown, sponsored by Apyx Medical. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Apyx Medical · Not applicable, Interventional, and Treatment
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.
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.
Apyx Medical is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System.
Device: Renuvion APR System
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 180
| Milestone | Renuvion APR System (Lower Face) | Untreated Control (Mid/Upper Face) |
|---|---|---|
| Started | 7 | 7 |
| Completed | 6 | 6 |
| Not completed | 1 | 1 |
| Withdrew: Subject missed day 180 visit | 1 | 1 |
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.
| units on a scale | Treatment Area | Control |
|---|---|---|
| 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) |
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.
| participants | Procedure With the Renuvion APR System in Lower Facelift Area |
|---|---|
| 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 |
| With Swelling D14 | 6 |
| With Swelling D45 | 0 |
| With Swelling D90 | 0 |
| With Swelling D180 | 0 |
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.
| percentage of lower facial area healed | Procedure With the Renuvion APR System in Lower Facelift Area |
|---|---|
| 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 |
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.
| Participants | Procedure With the Renuvion APR System in Lower Facelift Area |
|---|---|
| 15cc Blood Loss | 2 |
| 20cc Blood Loss | 2 |
| 70cc Blood Loss | 1 |
| 75cc Blood Loss | 1 |
| 300cc Blood Loss | 1 |
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.
| Participants | Procedure With the Renuvion APR System in Lower Facelift Area |
|---|---|
| Worse, Much Worse, Very Much Worse | 0 |
| No Change | 0 |
| Improved, Much Improved, Very Much Improved | 6 |
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.
| Participants | Procedure With the Renuvion APR System in Lower Facelift Area |
|---|---|
| Worse, Much Worse, Very Much Worse | 0 |
| No Change | 0 |
| Improved, Much Improved, Very Much Improved | 6 |
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.
| participants | Procedure With the Renuvion APR System in Lower Facelift Area |
|---|---|
| Noticed Improvement in the Lower Face | 6 |
| Satisfied with Procedure | 6 |
| Would Recommend to Friends & Family | 6 |
| Noted Improved Skin Dryness | 1 |
| Noted Improved Elasticity | 3 |
| Noted Skin Quality Improved | 2 |
| Noted Skin Appears More Youthful | 5 |
| Noted Improved Skin Radiance | 3 |
Collected over Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Procedure With the Renuvion APR System in Lower Facelift Area | 0/7 (0%) | 0/7 (0%) | 7/7 (100%) |
| Untreated Control (Upper Face) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Event | Procedure With the Renuvion APR System in Lower Facelift Area | Untreated Control (Upper Face) |
|---|---|---|
| Edema (ETE)Skin and subcutaneous tissue disorders | 7/7 | 0/7 |
| Bruise (ETE)Skin and subcutaneous tissue disorders | 6/7 | 0/7 |
| SeromaSkin and subcutaneous tissue disorders | 1/7 | 0/7 |
| Focal Skin BreakdownSkin and subcutaneous tissue disorders | 1/7 | 0/7 |
| Age, Continuous(years) | Procedure With the Renuvion APR System in Lower Facelift Area |
|---|---|
| Mean | 55.4 ± 6.4 |
| Sex: Female, Male(Participants) | Procedure With the Renuvion APR System in Lower Facelift Area |
|---|---|
| Female | 6 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Procedure With the Renuvion APR System in Lower Facelift Area |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Procedure With the Renuvion APR System in Lower Facelift Area |
|---|---|
| United States | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2023 to primary completion in Jul 2025, 19 months.
Results were first posted in Mar 2026, 8 months after primary completion.
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Cutis Laxa
Apyx Medical