title: A randomized, blinded clinical evaluation of a novel microwave device for treating axillary hyperhidrosis: the dermatologic reduction in underarm perspiration study.
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.
  
  
  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.
authors.affiliation: Department of Dermatology, St. Louis University, St. Louis, Missouri 63104, USA. glasermd@slu.edu
authors.forename: Dee Anna
authors.initials: DA
authors.lastname: Glaser
authors.forename: William P
authors.initials: WP
authors.lastname: Coleman
authors.forename: Larry K
authors.initials: LK
authors.lastname: Fan
authors.forename: Michael S
authors.initials: MS
authors.lastname: Kaminer
authors.forename: Suzanne L
authors.initials: SL
authors.lastname: Kilmer
authors.forename: Robert
authors.initials: R
authors.lastname: Nossa
authors.forename: Stacy R
authors.initials: SR
authors.lastname: Smith
authors.forename: Kathryn F
authors.initials: KF
authors.lastname: O'Shaughnessy
mesh_terms: D000328:Adult; D001365:Axilla; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006945:Hyperhidrosis / Q000503:physiopathology / Q000532:radiotherapy*; D008297:Male; D008872:Microwaves / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D013546:Sweating / Q000528:radiation effects*