ABSTRACT
BACKGROUND: Primary excessive sweating of the axilla affects approximately 3.12% of the US population and has a negative impact on individuals' lives. OBJECTIVES: We report the safety and effectiveness up to 90 days after treating excessive sweating with percutaneous radiofrequency when using a standardized protocol. METHODS: Twenty adult subjects (13 females, 7 males) aged 18-49 years with excessive sweating were enrolled in a single-center, single-treatment unblinded prospective study conducted at the FACES+ Aesthetic Facility. Forty axilla were treated using the ThermiGen ThermiRF device. The Dermatology Quality of Life Index (DLQI), the Hyperhidrosis Disease Severity Scale (HDSS), and the Odor Scale (OS) were used for qualitative assessment. RESULTS: Primary and secondary exploratory evaluations were favorable at 90 days, indicating a significant improvement in quality of life and a significant reduction in both sweating and odor. The DLQI demonstrated an average improvement of 10.8 points at day 30, 10.7 at day 60, and 11.1 at day 90 (P = 0.0001). At day 90, 100% of individuals had ≥50% improvement in their excessive sweating based on the HDSS. At the conclusion of the study, 15 subjects had a ≥1-point drop in their OS, whereas 5 subjects had no change (P = 0.0002). There were no serious adverse events reported during this study. All adverse events were classified as mild and moderate and resolved within 2 months. CONCLUSIONS: The addition of the ThermiRF temperature-controlled radiofrequency device to the algorithm of hyperhidrosis treatments reduces sweating and odor with minimal downtime.
