Histological Evaluation of Human Skin Bx to Assess the Effects of APR Tx as an Adjunct Procedure in Facelift Surgery
NCT ID: NCT06243744
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2023-11-30
2025-07-10
Brief Summary
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Participants will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
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.
TREATMENT
NONE
Study Groups
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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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Apyx Medical
INDUSTRY
Responsible Party
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Principal Investigators
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David Holcomb, M.D.
Role: PRINCIPAL_INVESTIGATOR
Holcomb & Kreithen Plastic Surgery and MedSpa
Melinda Lacerna, M.D.
Role: PRINCIPAL_INVESTIGATOR
LA Plastic Surgery & Dermatology
Locations
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LA Plastic Surgery and Dermatology
Bradenton, Florida, United States
Holcomb & Kreithen Plastic Surgery and MedSpa
Sarasota, Florida, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Mayoral FA. Skin tightening with a combined unipolar and bipolar radiofrequency device. J Drugs Dermatol. 2007 Feb;6(2):212-5.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Ulthera White Paper. Lower Face, Submentum, and Neck
Other Identifiers
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APX-21-04
Identifier Type: -
Identifier Source: org_study_id
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