Background: Reduction of wrinkles is increasingly becoming one of the most sought after aesthetic procedures. A variety of treatment modalities are available for this application, including radiofrequency energy in various modes of action.
Objective: The goal of the reported study was to evaluate the safety and efficacy of a new device, which implements an innovative combination of bipolar radiofrequency and vacuum.
Methods: Forty-six healthy adults at two clinics underwent eight facial treatments every 1 to 2 weeks. For 6 months after treatment, patients were assessed directly by two evaluators at each clinic (the treating physician and an additional reviewer) using standard evaluation tools-the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis and a visual analog scale.
Results: Significant improvement in the skin's appearance and texture was observed during the treatment course and continued to increase during the follow-up period. The mean elastosis score on the wrinkling and elastosis scale before treatment was 4.5 and was reduced to less than 2.5 by 6 months after treatment, representing a drop of an entire wrinkle class (from II to I) on this scale. The reported pain levels were low, and the subjects expressed their satisfaction with the treatment and its outcome. The adverse responses consisted mainly of transient erythema and burn/blistering; there were also a few occurrences of edema, purpura, and crusting and one transient hyperpigmentation. No permanent complications had occurred.
Conclusions: Our results demonstrate the safety and efficacy associated with use of this radiofrequency and vacuum device, employing Functional Aspiration Controlled Electrothermal Stimulation (FACES) technology, for reduction of facial wrinkles and elastosis.