New Rotative Radiofrequency Technology: A Multicenter Retrospective Study on Efficacy and Safety  

作　　者：José Antonio Ferrández Martínez Gregorio Viera Mármol Fabrizio Vignoli Joanet Perera Agustin Blanch Mara Suárez Alicia Robledo Jorge Reyna Vargas Lamas José Antonio Ferrández Martínez;Gregorio Viera Mármol;Fabrizio Vignoli;Joanet Perera;Agustin Blanch;Mara Suárez;Alicia Robledo Jorge;Reyna Vargas Lamas(Sinclair, Barcelona, Spain;Studio Vignoli, Bologna, Italy;Clinica Perla Medic, Alicante, Spain;Dr. Agustin Blanch Clinica, Barcelona, Spain;Intek Medical Technology S.L.U., Barcelona, Spain)

机构地区：[1]Sinclair, Barcelona, Spain [2]Studio Vignoli, Bologna, Italy [3]Clinica Perla Medic, Alicante, Spain [4]Dr. Agustin Blanch Clinica, Barcelona, Spain [5]Intek Medical Technology S.L.U., Barcelona, Spain

出　　处：《Journal of Cosmetics, Dermatological Sciences and Applications》2024年第1期69-83,共15页化妆品、皮肤病及应用期刊（英文）

摘　　要：Background: Non-ablative radiofrequency (RF) technology is widely used for the treatment of signs of aging, skin laxity, localized fat and cellulite. However, many RF devices suffer from technical limitations that make the results highly dependent on the user’s experience or clinical limitations that compromise safety, efficacy and comfort. Objective: To evaluate the efficacy and safety of a novel semi-automatic non-ablative RF device for skin tightening, body shaping and cellulite reduction. Materials and methods: A retrospective multicenter study was performed using a novel rotative RF device with temperature and impedance control (Sculpt&Shape^®, Sinclair, Spain). 58 subjects underwent a minimum of 4 treatments every 1-2 weeks. A total of 120 treatments (56.7% body and 43.3% facial) and 1034 sessions were performed. Efficacy was evaluated by 3 researchers using the Global Aesthetic Improvement Scale (GAIS) and anthropometric measurements were collected. Subject and practitioner satisfaction were recorded. Safety was evaluated by analyzing the perception of pain during the treatment and the side and adverse effects immediately after treatment and over the next 48 hours. Results: Between 25% and 50% improvement was achieved according to the GAIS. Statistically significant (p < 0.01) abdominal fold reduction of 5.1 mm and circumference reduction of 32.0 mm, 16.4 mm and 13.9 mm were recorded for the abdomen, legs and arms, respectively. 77.5% of subjects and 94.9% of practitioners were either satisfied or very satisfied. Minor adverse effects were found in 0.97% of the sessions. Conclusion: This novel semi-automatic rotative RF device has been found to provide treatments that are effective, safe and comfortable for both practitioners and subjects. .Background: Non-ablative radiofrequency (RF) technology is widely used for the treatment of signs of aging, skin laxity, localized fat and cellulite. However, many RF devices suffer from technical limitations that make the results highly dependent on the user’s experience or clinical limitations that compromise safety, efficacy and comfort. Objective: To evaluate the efficacy and safety of a novel semi-automatic non-ablative RF device for skin tightening, body shaping and cellulite reduction. Materials and methods: A retrospective multicenter study was performed using a novel rotative RF device with temperature and impedance control (Sculpt&Shape^®, Sinclair, Spain). 58 subjects underwent a minimum of 4 treatments every 1-2 weeks. A total of 120 treatments (56.7% body and 43.3% facial) and 1034 sessions were performed. Efficacy was evaluated by 3 researchers using the Global Aesthetic Improvement Scale (GAIS) and anthropometric measurements were collected. Subject and practitioner satisfaction were recorded. Safety was evaluated by analyzing the perception of pain during the treatment and the side and adverse effects immediately after treatment and over the next 48 hours. Results: Between 25% and 50% improvement was achieved according to the GAIS. Statistically significant (p < 0.01) abdominal fold reduction of 5.1 mm and circumference reduction of 32.0 mm, 16.4 mm and 13.9 mm were recorded for the abdomen, legs and arms, respectively. 77.5% of subjects and 94.9% of practitioners were either satisfied or very satisfied. Minor adverse effects were found in 0.97% of the sessions. Conclusion: This novel semi-automatic rotative RF device has been found to provide treatments that are effective, safe and comfortable for both practitioners and subjects. .

关 键 词：Rotative RADIOFREQUENCY RF CELLULITE Skin Tightening Body Shaping 

分 类 号：R73[医药卫生—肿瘤]