Skin Laxity Clinical Trial
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT06140628 -
A 28-day Clinical Study on Facial Skin Rejuvenation
|
N/A | |
| Completed |
NCT01971736 -
Efficacy of Long Pulsed 1064nm Laser for Facial Skin Tightening
|
N/A | |
| Completed |
NCT01713985 -
Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck
|
N/A | |
| Completed |
NCT01708382 -
Feasibility Study: Lifting and Tightening of the Elbows
|
N/A | |
| Completed |
NCT01708252 -
Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment
|
N/A | |
| Completed |
NCT01713998 -
Treatment of the Face and Neck With Lower Ulthera System Energy Settings
|
N/A | |
| Completed |
NCT04296201 -
Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology
|
N/A | |
| Completed |
NCT06000839 -
A Safety and Effectiveness Study of CELLBOOSTER® Lift (Stabilized Booster Complex Using CHAC Technology)
|
N/A | |
| Completed |
NCT06366503 -
Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation
|
N/A | |
| Completed |
NCT05929625 -
Radiofrequency and Ultrasound for Improvement of Skin Laxity and Wrinkles: Efficacy and Safety Evaluation
|
N/A | |
| Terminated |
NCT01713569 -
Feasibility Study: Histological Characterization After Treatment With the Ulthera® System
|
N/A | |
| Completed |
NCT01519934 -
A Retrospective Study to Evaluate the Effectiveness of the Ulthera System
|
N/A | |
| Completed |
NCT05605691 -
Post-Market Lower Eyelid Treatment With Renuvion in Greece
|
N/A | |
| Completed |
NCT04477187 -
Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling
|
N/A | |
| Completed |
NCT05590364 -
Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Back of the Hands
|
N/A | |
| Completed |
NCT04146584 -
Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
|
Phase 2 | |
| Recruiting |
NCT05750901 -
Evaluation of Fractional Ablative Laser Treatment for Skin Conditions
|
N/A | |
| Completed |
NCT04721600 -
Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance
|
N/A | |
| Recruiting |
NCT06157567 -
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
|
N/A | |
| Recruiting |
NCT05847530 -
Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions
|
N/A |