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A Randomized, Blinded Clinical Evaluation of a Novel Microwave Device for Treating Axillary Hyperhidrosis: The Dermatologic Reduction in Underarm Perspiration Study

2012; Lippincott Williams & Wilkins; Volume: 38; Issue: 2 Part 1 Linguagem: Inglês

10.1111/j.1524-4725.2011.02250.x

1524-4725

Dee Anna Glaser, William P. Coleman, Larry Fan, Michael S. Kaminer, Suzanne L. Kilmer, Robert Nossa, Stacy Smith, Kathryn F. O′Shaughnessy,

Sympathectomy and Hyperhidrosis Treatments

Duration of effect and effectiveness limit current options for treating axillary hyperhidrosis. A new microwave procedure for treatment of axillary hyperhidrosis has been tested.Adults with primary axillary hyperhidrosis were enrolled in a randomized, sham-controlled, blinded study. Subjects were required to have a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 and baseline sweat production greater than 50 mg/5 min. Procedures were administered using a proprietary microwave energy device that isolates and heats target tissue. Responders were defined as subjects reporting a HDSS score of 1 or 2. Subjects were followed for 6 months (sham group) or 12 months (active group).Thirty days after treatment, the active group had a responder rate of 89% (72/81), and the sham group had a responder rate of 54% (21/39) (P < .001). Treatment efficacy was stable from 3 months (74%) to 12 months (69%), when follow-up ended. Adverse events were generally mild, and all but one resolved over time.The procedure demonstrated statistically significant, long-term efficacy in sweat reduction. As with any new procedure, findings from this first investigational device study identified optimization strategies for the future.