Zelickson Brian D, Burns A Jay, Kilmer Suzanne L
Zel Skin and Laser Specialists, Edina, Minnesota; University of Minnesota Medical School, Minneapolis, Minnesota.
Lasers Surg Med. 2015 Feb;47(2):120-7. doi: 10.1002/lsm.22320. Epub 2015 Jan 13.
While cryolipolysis initially received FDA clearance for fat reduction in the abdomen and flanks, there was significant interest in non-surgical fat reduction for other sites, such as the inner and outer thighs. This article reports the results of an inner thigh study which contributed to FDA clearance of cryolipolysis for treatment of thighs.
STUDY DESIGN/MATERIAL AND METHODS: A flat cup vacuum applicator (CoolFit applicator, CoolSculpting System) was used to treat 45 subjects bilaterally in the inner thighs. Single cycle treatments were delivered at Cooling Intensity Factor (CIF) 41.6 for 60 minutes followed by 2 minutes of manual massage. Follow-up visits were conducted at 8 and 16 weeks. Efficacy was assessed by ultrasound imaging, circumference measurements, and photographs. Safety was assessed by monitoring adverse events. Patient satisfaction was evaluated by questionnaire.
Data is presented for n = 42 patients that completed the 16 week study follow-up and maintained their weight within 5 lbs. of baseline. Independent photo review from three blinded physicians found 91% correct identification of baseline clinical photographs. Ultrasound data indicate fat layer reduction of 2.8 mm. Circumferential measurements indicate mean reduction of 0.9 cm. Patient questionnaires reveal 93% were satisfied with the CoolSculpting procedure; 84% noticed visible fat reduction; 89% would recommend to a friend; and 91% were likely to have a second treatment. There were no device- or procedure-related serious adverse events.
The CoolFit flat cup vacuum applicator was found to deliver safe and effective cryolipolysis treatment to reduce inner thigh fat. Completed 16-week data from 42 subjects show 2.8 mm reduction in fat thickness and 0.9 cm reduction in circumference. Assessment of clinical photographs found 91% correct identification of baseline images. The results of this prospective, multi-center, interventional clinical study contributed to FDA clearance of cryolipolysis for treatment of thighs in April 2014.
虽然冷冻溶脂术最初获得美国食品药品监督管理局（FDA）批准用于减少腹部和侧腹的脂肪，但人们对非手术方式减少其他部位的脂肪也兴趣浓厚，比如大腿内侧和外侧。本文报告了一项大腿内侧研究的结果，该研究为冷冻溶脂术获得FDA批准用于治疗大腿提供了依据。
研究设计/材料与方法：使用扁平杯状真空敷贴器（CoolFit敷贴器，CoolSculpting系统）对45名受试者的双侧大腿内侧进行治疗。以冷却强度因子（CIF）41.6进行单次循环治疗60分钟，随后进行2分钟的手动按摩。在第8周和第16周进行随访。通过超声成像、周长测量和照片评估疗效。通过监测不良事件评估安全性。通过问卷调查评估患者满意度。
呈现了42名完成16周研究随访且体重维持在基线体重5磅范围内的患者的数据。三位盲法医生进行的独立照片评估发现，91%能够正确识别基线临床照片。超声数据显示脂肪层减少2.8毫米。周长测量表明平均减少0.9厘米。患者问卷调查显示，93%对CoolSculpting治疗满意；84%注意到明显的脂肪减少；89%会向朋友推荐；91%可能会接受第二次治疗。未出现与设备或操作相关的严重不良事件。
发现CoolFit扁平杯状真空敷贴器能提供安全有效的冷冻溶脂治疗以减少大腿内侧脂肪。42名受试者的16周完整数据显示脂肪厚度减少2.8毫米，周长减少0.9厘米。临床照片评估发现91%能够正确识别基线图像。这项前瞻性、多中心、介入性临床研究的结果促成了冷冻溶脂术于2014年4月获得FDA批准用于治疗大腿。
