Split-axilla comparison study of 0.5-MHz, invasive, bipolar radiofrequency treatment using insulated microneedle electrodes for primary axillary hyperhidrosis

Abstract

Background Energy-delivering devices can be used to induce thermal coagulation of the eccrine sweat glands for treating primary axillary hyperhidrosis (PAH). Objective The objective of this study was to compare the efficacy and safety of invasive, bipolar radiofrequency (RF) treatment for PAH. Methods A split-axilla study was performed to compare the clinical outcomes of 0.5 MHz, invasive, bipolar RF treatment with treatment settings of a longer conduction time and lower power (LC/LP) vs a shorter conduction time and higher power (SC/HP) for treating PAH. Results The in vivo study revealed median hyperhidrosis disease severity scale scores of 1.5 (interquartile range [IQR], 1-2) at 1 month and 1 (IQR, 1-2) at 3 months after treatment with the LC/LP setting, compared to baseline. Meanwhile, the other side of the axillae treated with the SC/HP setting showed scores of 2 (IQR, 2-2) at 1 month and 2 (IQR, 1.25-2) at 3 months. Analysis via a linear mixed model revealed a significant interaction (group, P = .011; time, P < .001; and group x time, P = .048) between treatment group and time. Conclusion PAH can be effectively and safely treated with invasive, multilayered, multiple-pass, 0.5-MHz, bipolar RF treatment, particularly with LC/LP.