Shapiro Steven D, Eros Yoav, Abrahami Yoav, Leviav Amos
Gardens Dermatology, Cosmetic Surgery Center, Palm Beach Gardens, FL, USA.
Lasers Surg Med. 2012 Aug;44(6):453-8. doi: 10.1002/lsm.22044. Epub 2012 Jun 29.
Patient demand for non-surgical, non-invasive, and no-downtime wrinkle reduction treatment procedures has grown dramatically over the past decade as new treatments and technologies have been introduced. This study was performed in order to evaluate the safety and efficacy of the TriPollar radiofrequency (RF) technology and intended for wrinkle reduction treatment.
Thirty-seven Subjects were recruited in two sites and were treated for the reduction of facial wrinkles and rhytides and followed for 3 months after the last treatment. The safety of using the TriPollar system was established by the physicians' assessments and observations of adverse events after each treatment. To evaluate treatment efficacy, pre- and post-treatment photos were assessed using a blinded evaluation by two uninvolved physicians.
No unexpected adverse side effects were detected or reported. All subjects participating in the study reported no pain or mild pain during the treatments. The photographic analysis of pre- and post-treatment by the two blinded physicians revealed improvement (downgrade of at least 1 score according to the Fitzpatrick scale) in 94% (according to first reviewer) and 97% (according to second reviewer) of study subjects. All patients (100%) were satisfied from treatment results to a different extent.
The results of this study clearly indicate that the TriPollar system offers a non-invasive, effective, safe and virtually painless wrinkle and rhytides reduction treatment.
在过去十年中，随着新的治疗方法和技术的出现，患者对非手术、非侵入性且无停工期的皱纹减少治疗程序的需求急剧增长。本研究旨在评估TriPollar射频（RF）技术用于减少皱纹治疗的安全性和有效性。
在两个地点招募了37名受试者，对其进行面部皱纹和皱纹减少治疗，并在最后一次治疗后随访3个月。通过医生对每次治疗后不良事件的评估和观察来确定使用TriPollar系统的安全性。为了评估治疗效果，由两名不相关的医生进行盲法评估，对治疗前后的照片进行评估。
未检测到或报告意外的不良副作用。所有参与研究的受试者在治疗期间均报告无疼痛或轻度疼痛。两位盲法医生对治疗前后照片的分析显示，94%（根据第一位审阅者）和97%（根据第二位审阅者）的研究受试者有改善（根据菲茨帕特里克量表至少降低1分）。所有患者（100%）在不同程度上对治疗结果感到满意。
本研究结果清楚地表明，TriPollar系统提供了一种非侵入性、有效、安全且几乎无痛的减少皱纹和皱纹的治疗方法。
