Introduction Facial aging is a common dermatological and plastic surgical concern. As patients today wish to avoid surgical intervention, noninvasive monopolar radiofrequency (NMRF) can be a useful tool to address this concern, but results have varied by target depth. A dual-frequency NMRF system (6.78 MHz and 2 MHz) is designed to support depth-dependent tissue heating across dermal and subdermal planes. This study aimed to evaluate short-term clinical outcomes and safety in a prospective multicenter trial. Methods Thirty-nine subjects at four clinical sites completed the study. The protocol allowed up to three treatments spaced four weeks apart; however, all subjects completed the study after two sessions. Treatments were delivered at three different depths (shallow, middle, and deep), as indicated by the target condition and facial anatomical zone. Standardized clinical photography was taken at baseline, 30- and 90-day timepoints. A five-point Global Aesthetic Improvement Scale (GAIS) was assessed by the principal investigators at the 30- and 90-day assessments, and patients subjectively scored their satisfaction using a study-specific patient satisfaction score (PSS; six-point scale). GAIS results were evaluated for statistical significance; satisfaction was summarized descriptively with exact 95% CIs. Any adverse events were documented. Results A total of 39 subjects received two treatment sessions. Clinician-scored GAIS achieved three or above by 84.6% (33/39; 95% CI, 69.5-94.1) of subjects at 30-day and 92.3% (36/39; 95% CI, 79.1-98.4) of subjects at 90-day timepoints (p=0.0293 and 0.0008, respectively). Patient satisfaction was also high, scoring of four or above for 79.5% of participants at 30-day (31/39; 95% CI, 64.5-89.2%) and 84.6% at 90-day (33/39; 95% CI, 70.3-92.8%). There were no long-lasting adverse events. Conclusion Dual-frequency NMRF, applied with depth-dependent settings in this study, was associated with significant short-term improvement and high satisfaction at 30 and 90 days, with no persistent adverse events. These findings support further evaluation of this noninvasive RF approach for facial aging.
Weiss et al. (Mon,) studied this question.
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