Abstract
BACKGROUND: Aging is a multifactorial response to genetic preprogramming nuances, sun exposure, and ultraviolet radiation. Recently, there has been a paradigm shift toward minimally invasive rejuvenation. OBJECTIVE: This prospective multicenter study aims to evaluate the efficacy and safety of a novel hands-free bipolar bulk radiofrequency (RF) device in terms of improvement in skin appearance. PATIENTS AND METHODS: This multicenter prospective study enrolled subjects aged 35 to 75 years with visible signs of aging. The primary objective was to evaluate skin appearance pretreatment and at 1, 3, and 6 months after the final treatment. Each patient received 3 total treatments to the chin and cheeks using the hands-free RF device spaced 2 weeks apart. RESULTS: In total, data from 87 patients were assessed from 6 treatment sites. The average age was 54 years (range 35-75 years). Most patients were female (97%), and Fitzpatrick skin types I to V were represented. Overall, patients found the procedures to be relatively pain-free, and both patients and investigators felt they noted some improvement in their skin appearance. Histological sections demonstrated an increase in collagen or elastic fibers within the papillary dermis. CONCLUSION: This study supports the use of this novel noninvasive hands-free bipolar facial remodeling device for the improvement of skin appearance.