Clinical Evaluation of a Microwave Device for Treating Axillary Hyperhidrosis

BACKGROUND: A third-generation microwave-based device has been developed to treat axillary hyperhidrosis by selectively heating the interface between the skin and underlying fat where the sweat glands reside. MATERIALS AND METHODS: Thirty-one (31) adults with primary axillary hyperhidrosis were enrolled. All subjects had one to three procedure sessions over a 6-month period to treat both axillae fully. Efficacy was assessed using the Hyperhidrosis Disease Severity Scale (HDSS), gravimetric weight of sweat, and the Dermatologic Life Quality Index (DLQI), a dermatology-specific quality-of-life scale. Subject safety was assessed at each visit. Subjects were followed for 12 months after all procedure sessions were complete. RESULTS: At the 12-month follow-up visit, 90.3% had HDSS scores of 1 or 2, 90.3% had at least a 50% reduction in axillary sweat from baseline, and 85.2% had a reduction of at least 5 points on the DLQI. All subjects experienced transient effects in the treatment area such as swelling, discomfort, and numbness. The most common adverse event (12 subjects) was the presence of altered sensation in the skin of the arm that resolved in all subjects. CONCLUSION: The device tested provided efficacious and durable treatment for axillary hyperhidrosis.