Kaminer Michael S, Coleman William P, Weiss Robert A, Robinson Deanne M, Grossman Jody
*Skincare Physicians, Chestnut Hill, Massachusetts; †Coleman Cosmetic and Dermatologic Surgery Center, Metairie, Louisiana; ‡Maryland Laser Skin and Vein Institute, Hunt Valley, Maryland; §Connecticut Dermatology Group, Milford, Connecticut; ‖Ulthera, Inc., Mesa, Arizona.
Dermatol Surg. 2017 Oct;43(10):1240-1248. doi: 10.1097/DSS.0000000000001218.
Cellulite is a common female cosmetic concern for which no single treatment option had been proven effective over the long term. A novel tissue stabilized-guided subsicion system (TS-GS system) has demonstrated significant reduction in the appearance of cellulite after treatment.
The objective of this extended follow-up period was to assess the effectiveness of TS-GS out to 3 years after initial treatment.
After completing an open-label, multicenter, pivotal study, 45 subjects were followed for an extended period of up to 3 years after receiving a single treatment using the TS-GS system. Treatment areas were photographed prior to the procedure and at multiple time points post-treatment throughout the 3 years. In this open-label study, subjects served as their own controls. Effectiveness was assessed based on blinded independent physician panel assessments of improvement from baseline using a cellulite severity scale. Subject aesthetic improvement and patient-reported satisfaction were also collected.
The results of this trial supported Food and Drug Administration clearance of the device for the long-term reduction in the appearance of cellulite following TS-GS.
These data further demonstrate the safety and efficacy of this treatment with no reduction in treatment benefits out to 3 years.
橘皮组织是女性常见的美容问题，长期以来没有单一的治疗方法被证明有效。一种新型的组织稳定引导下的皮下切开系统（TS-GS系统）在治疗后已显示出橘皮组织外观有显著改善。
本次延长随访期的目的是评估初次治疗后3年内TS-GS系统的有效性。
在完成一项开放标签、多中心、关键研究后，45名受试者在接受TS-GS系统单次治疗后进行了长达3年的延长随访。在治疗前以及治疗后的3年中多个时间点对治疗区域进行拍照。在这项开放标签研究中，受试者自身作为对照。有效性是基于独立医生小组使用橘皮组织严重程度量表对与基线相比的改善情况进行的盲法评估。还收集了受试者的美学改善情况和患者报告的满意度。
该试验结果支持美国食品药品监督管理局批准该设备用于TS-GS治疗后长期减少橘皮组织外观。
这些数据进一步证明了该治疗方法的安全性和有效性，且在3年内治疗效果没有降低。
