Assessment of the safety and efficacy of a bipolar multi-frequency radiofrequency device in the treatment of skin laxity

摘要

This study assessed the safety and efficacy of a bipolar, multi-frequency, vacuum-assisted radiofrequency device in the temporary improvement of thigh skin laxity. A secondary outcome measure included the determination of patient tolerability. Fourteen female study subjects between the ages of 30 and 61 years with Fitzpatrick skin types I-V completed the study. Each subject underwent a single, bipolar, multi-frequency, vacuum-assisted radiofrequency treatment with frequencies ranging between 0.80 and 2.45 MHZ. Suction was applied adjustable up to 500 mbars and skin temperatures were maintained between 39 and 42o C. Eight out of the fourteen (57.14%) study subjects noted an improvement in the appearance of their skin from baseline compared to their three-month follow-up while the independent, blinded investigator noted an improvement in eleven out of the fourteen (78%) subjects. All treatments were well tolerated and side effects were minimal, consisting of mild intra-operative discomfort, transient erythema and slight post-procedure edema noted in a minority of study subjects.This study demonstrated that a single treatment with a novel, bipolar, multi-frequency radiofrequency device applied to thigh skin resulted in a positive clinical improvement in 78% of investigator-assessed subjects. Furthermore, this study proved that the treatment is tolerable and safe for all skin types.