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.
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