Ehrenraich Mimi, Wolff Ety, Grumer Suzy Roffe, Lozano Olalla Calvo, Vargas Reyna, Belenky Inna
Mimi Ehrenraich Aesthetic Clinics, Haifa, Israel.
Wolff Aesthetics Center, Herzliya, Israel.
J Cosmet Dermatol. 2025 Apr;24(4):e70127. doi: 10.1111/jocd.70127.
The aging process reflects decreased tissue elasticity and a rearrangement of subcutaneous volume, resulting in superficial wrinkles and three-dimensional changes in skin topography. Radiofrequency (RF)-based approaches have become increasingly adopted in recent decades due to their relatively short downtime and significantly reduced risk of adverse effects.
The aim of this study was to evaluate the safety and efficacy of the V-FC handpiece through a multicenter retrospective study as well as ex vivo and in vivo analyses.
The V-FC handpiece was used once a week for a treatment course of 3-6 sessions. The clinical evaluation of 33 patients included demographics, BMI, assessment of skin laxity, and rate of improvement. An ex vivo study with porcine tissue assessed the penetration depth of RF, while device performance was evaluated in an in vivo animal histological analysis.
No significant adverse effects were recorded during the treatment course or at short- and long-term follow-ups (1, 3, and 52 months). The average skin laxity grade baseline was 34% lower at the end of the treatment course, with the average rate of improvement assessed as moderate. The ex vivo minimal and maximal penetration depths were 3.2-11.3 mm (±10%). The in vivo histopathological analysis showed no signs of acute heat injury at any treatment setting, including the maximum RF power. Additionally, staining showed a power-related progressive proliferation of fibroblasts, elastin fibers, and neocollagenesis, which was significantly higher 4 weeks after treatment.
The new RF device demonstrates an effective treatment for facial contouring with a proven short- and long-term high safety profile.
衰老过程反映出组织弹性下降和皮下容积重新分布，导致皮肤出现浅表皱纹和三维地形变化。近几十年来，基于射频（RF）的方法因其停机时间相对较短且不良反应风险显著降低而越来越多地被采用。
本研究旨在通过多中心回顾性研究以及体外和体内分析来评估V-FC手持件的安全性和有效性。
V-FC手持件每周使用一次，疗程为3至6次。对33例患者的临床评估包括人口统计学、体重指数、皮肤松弛度评估和改善率。用猪组织进行的体外研究评估了射频的穿透深度，同时在体内动物组织学分析中评估了设备性能。
在治疗过程中以及短期和长期随访（1、3和52个月）期间均未记录到明显的不良反应。治疗疗程结束时，平均皮肤松弛度等级基线降低了34%，改善率评估为中等。体外最小和最大穿透深度为3.2至11.3毫米（±10%）。体内组织病理学分析显示，在任何治疗设置下，包括最大射频功率，均未出现急性热损伤迹象。此外，染色显示成纤维细胞、弹性纤维和新胶原形成与功率相关的渐进性增殖，治疗后4周显著更高。
这种新型射频设备对面部轮廓塑造显示出有效的治疗效果，已证实具有短期和长期的高安全性。
