Multicenter Efficacy Trial of a Percutaneous Radiofrequency System for the Reduction of Glabellar Lines.

Abstract

Bipolar percutaneous radiofrequency (RF) is an established method for ablation of distal peripheral branches of the facial nerve to produce weakness of the corrugator muscle. Recent developments to the Serene RF system (Serene Medical, Inc., Pleasanton, CA) allowing for safer and more predictable results highlighted a need for prospective clinical data. The authors sought to assess the ability of percutaneous RF to safely improve the appearance of dynamic glabellar lines for a minimum of 3 months and up to 1 year. This prospective study enrolled 78 patients across 5 centers in the United States. The most distal branches of the medial and lateral facial nerve innervation to the brow depressor/corrugator complex were treated. Follow-up was at 3 days by telephone and in-office at 7 days and 3, 6, 9, and 12 months posttreatment. Patients were evaluated employing the Merz scale for dynamic glabellar lines. At 3 months, 93.6% of patients had a ≥1-point Merz scale improvement in dynamic glabellar lines based on independent, blinded review. Sustained ≥2-point improvement was present in 60% and 20% of patients at 3 and 12 months, respectively. Overall satisfaction remained >60% through 6 months and >50% at 12 months. All device- or procedure-related adverse events were mild (90%) or moderate (10%) and resolved without medical intervention. Bipolar percutaneous RF may be adopted in conjunction with surgery or as an office-based procedure where it can serve as a minimally invasive alternative to, or in concert with, Botulinum Toxin A therapy.