A Prospective Trial: Handsfree Thermoregulated Bipolar Radiofrequency for Face and Neck Contouring

BACKGROUND: The use of radiofrequency in aesthetic surgery has evolved significantly since it was first introduced in the early 2000s. Nonexcisional correction of the lower one-third of the face and neck has long been a challenging problem. The purpose of this prospective study was to assess the safety and efficacy of the first handsfree thermoregulated bipolar radiofrequency device for face and neck contouring. METHODS: This prospective multicenter (New York, Nevada) IRB-approved study evaluated healthy candidates who desired noninvasive correction of their lower face and neck laxity. The primary objective of this study was to evaluate safety and soft tissue remodeling pretreatment and at 1-, 3-, and 6-months post last treatment. Assessment was made using blinded evaluators, 3D photographic analysis (Quantificare, France), and volumetric measurements. Investigator and subject assessments were obtained using a 0-4 point Likert scale. RESULTS: A total of 34 patients completed both the cheek and chin applicator treatment series. Average age of patients was 38 (STD 3.4), BMI 27 (STD 2.2), average Baker Face & Neck classification 2.6 (STD 1.1), and average Fitzpatrick type 2.4 (STD 1.2). Mean treatment time was 41 min (STD 3.5) with a temperature of 42°C–43°C. Patient discomfort data were statistically very low based on t-test analysis. Satisfaction metrics measured at 1- and 3-month follow-up demonstrated a significant change in subject skin appearance, subject overall satisfaction, and investigator improvement perception. More patients were satisfied at the 3-month follow-up compared with the 1-month follow-up for all three measures. Volumetric data demonstrated an average change of −3.2 cm(3) (STD ±1.2 cm(3)) per side for the cheek applicator and −4.1 (STD ±2.3) for the submental applicator. Of note there were cases where volume increases were noted that were believed to be related to soft tissue contraction. CONCLUSIONS: This is the first prospective study to evaluate a handsfree thermoregulated bipolar radiofrequency device for face and neck contouring. This device demonstrates a significant advance in the control and delivery of radiofrequency for aesthetic purposes. With a favorable safety and comfort profile, this device is able to concentrate thermal energy consistently at a depth that allows for fibroseptal network tightening to improve lower third of face and submental soft tissue contraction.