Laser and Skin Surgery of New York, New York, New York.
Laser and Skin Surgery Center of Northern, California, Sacramento, California.
Dermatol Surg. 2019 Aug;45(8):1057-1062. doi: 10.1097/DSS.0000000000001911.
Cellulite is a common female cosmetic concern for which there are few treatment options with long-term effectiveness data. The aim of this multisite prospective registry study was to collect observational data on the real-life clinical use of a tissue stabilized-guided subcision (TS-GS) system for long-term improvement of cellulite appearance.
Fifty-three subjects were enrolled and received a single treatment using the TS-GS system. Physicians treated the subjects according to their standard of care. Global Aesthetic Improvement Scale (GAIS) was completed by the patient and clinician assessing overall aesthetic improvement after 180 days. Treatment parameters, pain scores, quality of life data, and expected treatment effects and adverse events were also recorded throughout the study.
The patient and physician GAIS scores at Day 180 revealed an overall improvement in 91% and 96% of patients, respectively. Quality of life and self-confidence scores also improved through 180 days. No serious adverse events were reported. Expected treatment effects were similar to those reported in the pivotal trial supporting FDA clearance.
This study demonstrated significant improvement in the appearance of cellulite after a single treatment session in patients with moderate-to-severe cellulite. These results are consistent with the previously published the pivotal study data.
橘皮组织是一种常见的女性美容问题，目前治疗选择很少，且缺乏长期有效性数据。本多中心前瞻性注册研究的目的是收集组织稳定引导下皮下分离（TS-GS）系统在改善橘皮外观方面的真实临床应用的观察数据。
53 名受试者接受了 TS-GS 系统的单次治疗。医生根据其标准护理对受试者进行治疗。在 180 天后，患者和临床医生使用全球美学改善量表（GAIS）评估整体美学改善情况。在整个研究过程中，还记录了治疗参数、疼痛评分、生活质量数据、预期治疗效果和不良反应。
第 180 天，患者和医生的 GAIS 评分分别显示 91%和 96%的患者有整体改善。生活质量和自信心评分也在 180 天内得到改善。未报告严重不良事件。预期的治疗效果与支持 FDA 批准的关键性试验报告的结果相似。
这项研究表明，在患有中重度橘皮组织的患者中，单次治疗后橘皮组织的外观有显著改善。这些结果与之前发表的关键性研究数据一致。
