A prospective clinical study to evaluate the efficacy and safety of cellulite treatment using the combination of optical and RF energies for subcutaneous tissue heating.

BACKGROUND There have not been any published studies on the use of radiofrequency (RF)-light-based technologies for the treatment of cellulite. Only preliminary results have recently been reported (ASDS Proceedings, September 2004). OBJECTIVE This two-center study investigated the safety and effectiveness of combined energies for cellulite treatment using the VelaSmoothtrade mark system. METHODS Thirty-five female subjects with cellulite and/or skin irregularities on the thighs and/or buttocks were treated with the VelaSmooth device. Patients received from eight to 16 treatments twice weekly. All patients maintained their normal lifestyle, and diet and fluid consumption. The circumference of the right and left medial thighs was measured at both baseline and approximately 4 weeks after the last treatment. During the last follow-up visit, the physician graded the level of improvement in skin smoothing and/or cellulite improvement using pre- and post-treatment photographs. Three patients provided biopsy specimens for histological assessment. RESULTS All study patients showed some level of reduction in thigh circumference after 8 weeks of treatment; indeed, 70% of all patients showed such a reduction after 4 weeks of treatment. Also, 100% of all patients showed some level of improvement in skin texture and cellulite. The mean decrease in circumference was 0.8 inches. Some patients demonstrated reductions of more than 2 inches. There were minimal complications associated with treatment. CONCLUSION This preliminary study demonstrates that the VelaSmooth system can have a beneficial effect on cellulite appearance. Further studies are needed to better define the mechanisms by which RF and light energies affect subdermal tissues and develop a method of quantified cellulite analysis.