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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renuvion APR System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Holcomb, M.D. | Holcomb & Kreithen Plastic Surgery and MedSpa | Principal Investigator |
| Melinda Lacerna, M.D. | LA Plastic Surgery & Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LA Plastic Surgery and Dermatology | Bradenton | Florida | 34208 | United States | ||
| Holcomb & Kreithen Plastic Surgery and MedSpa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8796667 | Background | 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. | |
| 1886941 | Background | 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. |
| Label | URL |
|---|---|
| Ulthera White Paper. Lower Face, Submentum, and Neck | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Renuvion APR System (Lower Face) | Lower facial region treated with the Renuvion APR System during lower facelift surgery. Treatment was applied to the neck, submentum, and lower facial skin flap. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2024 |
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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.
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| 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. | 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. | Day 180 |
| Sarasota |
| Florida |
| 34237 |
| United States |
| 10206052 | Background | 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. |
| 8982996 | Background | 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. |
| 16020210 | Background | 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. |
| 11860431 | Background | 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. |
| 17373181 | Background | Mayoral FA. Skin tightening with a combined unipolar and bipolar radiofrequency device. J Drugs Dermatol. 2007 Feb;6(2):212-5. |
| 15355357 | Background | 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. |
| 14967794 | Background | 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. |
| 12877230 | Background | 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. |
| 20835826 | Background | 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. |
| 21751063 | Background | 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. |
| 24335016 | Background | 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. |
| 21606638 | Background | 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. |
| 32537370 | Background | 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. |
| 31688753 | Background | van Dongen JA, Langeveld M, van de Lande LS, Harmsen MC, Stevens HP, van der Lei B. The Effects of Facial Lipografting on Skin Quality: A Systematic Review. Plast Reconstr Surg. 2019 Nov;144(5):784e-797e. doi: 10.1097/PRS.0000000000006147. |
| 12786700 | Background | Narins RS, Brandt F, Leyden J, Lorenc ZP, Rubin M, Smith S. A randomized, double-blind, multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Dermatol Surg. 2003 Jun;29(6):588-95. doi: 10.1046/j.1524-4725.2003.29150.x. |
| 32660606 | Background | Boroni M, Zonari A, Reis de Oliveira C, Alkatib K, Ochoa Cruz EA, Brace LE, Lott de Carvalho J. Highly accurate skin-specific methylome analysis algorithm as a platform to screen and validate therapeutics for healthy aging. Clin Epigenetics. 2020 Jul 13;12(1):105. doi: 10.1186/s13148-020-00899-1. |
| 29218661 | Background | Fuchshuber P, Schwaitzberg S, Jones D, Jones SB, Feldman L, Munro M, Robinson T, Purcell-Jackson G, Mikami D, Madani A, Brunt M, Dunkin B, Gugliemi C, Groah L, Lim R, Mischna J, Voyles CR. The SAGES Fundamental Use of Surgical Energy program (FUSE): history, development, and purpose. Surg Endosc. 2018 Jun;32(6):2583-2602. doi: 10.1007/s00464-017-5933-y. Epub 2017 Dec 7. |
| FG001 | Untreated Control (Mid/Upper Face) | Mid and upper facial regions that did not receive Renuvion treatment and served as within-subject controls. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Procedure With the Renuvion APR System in Lower Facelift Area | Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System. Baseline Characteristics are reported once due to the split body design. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | units on a scale | Baseline, Day 180 |
|
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| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Number | participants | Post-Treatment, Day 1, 7, 14, 45, 90, 180 |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of lower facial area healed | Post-Treatment, Day 1, 7, 14, 45, 90, 180 |
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| Primary | 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. | Posted | Count of Participants | Participants | During Procedure (Day 0) |
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| Primary | 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. | Posted | Count of Participants | Participants | Day 180 |
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| Primary | 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. | Posted | Count of Participants | Participants | Day 180 |
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| Primary | 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. | Posted | Number | participants | Day 180 |
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Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Procedure With the Renuvion APR System in Lower Facelift Area | Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System. 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. | 0 | 7 | 0 | 7 | 7 | 7 |
| EG001 | Untreated Control (Upper Face) | The upper face area served as the untreated control. | 0 | 7 | 0 | 7 | 0 | 7 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruise (ETE) | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Edema (ETE) | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Seroma | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Focal Skin Breakdown | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kari Larson, Sr. Director, Clinical Affairs | Apyx Medical | 800-537-2790 | kari.larson@apyxmedical.com |
| Dec 5, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| Unknown or Not Reported |
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| Histological Findings Elastin Density Baseline |
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| Histological Findings Elastin Density D180 |
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