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临床试验/NCT07590843
NCT07590843已完成不适用

Efficacy and Safety of a Novel Monopolar Radiofrequency Device for Mid and Lower Face Rejuvenation: A Retrospective Pre-Post Comparative Study

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Clinician-Assessed Improvement in Standardized Clinical Photographs

研究概览

简要总结

The aim of this study is to evaluate the efficacy and safety of mid- and lower-face lifting and contouring treatments using the novel monopolar radiofrequency device, NeoSculpt.

详细描述

Aging of the face progresses through complex structural changes, including a decrease in skin elasticity, collagen loss, changes in subcutaneous fat distribution, and relaxation of the superficial musculoaponeurotic system (SMAS). These changes are particularly prominent in the mid and lower face, which has led to the widespread use of non-invasive energy-based lifting and contouring procedures in cosmetic and dermatology clinical practices.

Traditional laser and high-output radiofrequency (RF) based lifting treatments generally deliver brief high-temperature energy (over 70°C) to tissues, inducing protein denaturation and coagulation, followed by collagen remodeling through the wound healing process to achieve long-term effects. Although these treatments can induce relatively rapid clinical changes, side effects such as pain during the procedure, as well as erythema, edema, and blisters, which are associated with thermal damage, have been reported.

To address these limitations, there has been increasing interest in low-temperature-maintaining RF treatments that minimize tissue degeneration while inducing biological responses. In particular, RF stimulation in the range of 43-45°C is known to be a temperature range that does not induce tissue coagulation and is believed to trigger reactions related to cellular metabolic activation and programmed cell death (apoptosis), rather than necrosis-based damage with accompanying acute inflammatory responses. This approach has advantages, including relatively less pain, shorter recovery times, and the possibility of repeated treatments.

Recent studies have also reported that TRPV1 receptors, activated by thermal stimulation above 43°C, may be associated not only with pain transmission but also with the activation of fibroblasts, regulation of collagen and extracellular matrix (ECM) synthesis, and regulation of adipocyte metabolism. Some experimental studies have observed an increase in fibroblast proliferation and ECM production when RF energy was applied to maintain a temperature range of 43-45°C for a certain period. However, this evidence has been largely limited to studies focusing on the skin layer, and there is still limited systematic human research on the clinical efficacy and safety of RF treatments that simultaneously stimulate both the skin and subcutaneous fat layers.

NeoSculpt is a monopolar RF system designed with a multi-channel handpiece structure using different frequencies (1 MHz and 2 MHz) to deliver energy progressively to the dermal-SMAS interface and subcutaneous fat layers. Through a low-temperature-maintaining RF protocol, it is expected to achieve mid- and lower-face lifting and contouring effects. However, objective data regarding the efficacy, safety, and clinical changes associated with the use of this device in actual clinical settings are not yet sufficiently accumulated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Adult patients who have undergone mid- and lower-face lifting and contouring treatments using NeoSculpt RF
  • Cases where pre- and post-treatment evaluation data are available after completing 3 sessions

排除标准

  • Missing key evaluation data
  • Cases where follow-up observations were not conducted after treatment

研究组 & 干预措施

20 patients

This study is an observational, retrospective cohort study. Considering the number of patients available at a single institution and the feasibility of the study, a total of 20 participants were selected. This is considered the minimum number of subjects required to perform the pre-post comparative analysis planned in this study and to assess the clinical trends and safety of mid- and lower-face lifting and contouring treatments. In this study, personally identifiable information (such as name, resident registration number, etc.) will not be collected, and research data will be anonymized and analyzed using a study ID number. All data will be managed by the principal investigator, and use for purposes other than the research is restricted.

干预措施: NeoSculpt (Device)

结局指标

主要结局

Clinician-Assessed Improvement in Standardized Clinical Photographs

时间窗: baseline, 1month, 2month, 3month, 6month

Two blinded dermatologists independently evaluate standardized clinical photographs taken before and after treatment. Improvement is rated on a 5-point scale (0 = no improvement, 1 = minimal improvement \[1-25%\], 2 = moderate improvement \[26-50%\], 3 = marked improvement \[51-75%\], 4 = excellent improvement \[\>75%\]). Higher scores indicate greater improvement.

Change in Mid- and Lower-Face Volume Measured by 3D Photographic System

时间窗: Baseline, Month 1, Month 2, Month 3, Month 6

Facial volume in the mid-cheek, jawline, and nasolabial fold regions is measured using a 3D photographic system. Change from baseline is reported in cubic millimeters (mm³).

Change in Skin Layer Collagen Thickness Measured by Ultrasound

时间窗: Baseline, Month 1, Month 2, Month 3, Month 6

Collagen thickness of the dermal layer is measured using high-frequency ultrasound imaging. Change from baseline is reported in millimeters (mm).

Change in SMAS-Adjacent Adipose Tissue Thickness Measured by Ultrasound

时间窗: Baseline, Month 1, Month 2, Month 3, Month 6

Thickness of adipose tissue adjacent to the superficial musculoaponeurotic system (SMAS) is measured using high-frequency ultrasound imaging. Change from baseline is reported in millimeters (mm).

Investigator Global Assessment (IGA) Score for Overall Facial Improvement

时间窗: Baseline, Month 1, Month 2, Month 3, Month 6

Three independent, blinded dermatologists evaluate overall facial improvement using the Investigator Global Assessment (IGA) scale. Scores range from 0 to 4 (0 = no improvement, 1 = minimal improvement \[1-25%\], 2 = moderate improvement \[26-50%\], 3 = marked improvement \[51-75%\], 4 = excellent improvement \[\>75%\]). Higher scores indicate greater improvement. The mean score across three evaluators is reported.

Incidence of Treatment-Emergent Adverse Events

时间窗: baseline, 1month, 2month, 3month, 6month

* Description: The number and percentage of participants experiencing adverse events following treatment, including but not limited to erythema, edema, blistering, and burns. Adverse events are recorded at each follow-up visit and categorized by type and severity. * Unit of Measure: Number of participants with adverse events

Duration and Resolution of Adverse Events

时间窗: Month 1, Month 2, Month 3, Month 6

Description: For participants who experience adverse events, the duration (in days) from onset to resolution is recorded. Clinical course and any management performed are documented at each follow-up visit. Unit of Measure: Days

次要结局

  • Patient-Reported Pain Score During Treatment(Month 1, Month 2, Month 3)
  • Patient-Reported Overall Satisfaction Score(Month 1, Month 2, Month 3, Month 6)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bo Ri Kim

Clinical Professor

Seoul National University Bundang Hospital

研究点 (1)

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