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Dermatol Surg. 2012 Feb;38(2):185-91. doi: 10.1111/j.1524-4725.2011.02250.x. Epub 2012 Jan 30.

A randomized, blinded clinical evaluation of a novel microwave device for treating axillary hyperhidrosis: the dermatologic reduction in underarm perspiration study.

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1
Department of Dermatology, St. Louis University, St. Louis, Missouri 63104, USA. glasermd@slu.edu

Abstract

BACKGROUND:

Duration of effect and effectiveness limit current options for treating axillary hyperhidrosis. A new microwave procedure for treatment of axillary hyperhidrosis has been tested.

STUDY DESIGN/MATERIALS AND METHODS:

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).

RESULTS:

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.

CONCLUSIONS:

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.

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