Microwave Device Offers Long-Term Treatment for Hyperhidrosis
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR LASER MEDICINE AND SURGERY
Major Finding: First study: Efficacy of treatment in 81 patients as determined by HDSS scores was 89% at 30 days and 67% at 6 months. Second study: Of 25 patients seen at 3 months, all had HDSS scores of 1 or 2 (100% efficacy).
Data Source: Two studies of 120 and 31 patients, respectively, with axillary hyperhidrosis
Disclosures: The studies were sponsored by Miramar Labs. Dr. Lupin disclosed that he received a research grant for the study and travel expenses from Miramar, and also received honoraria and travel expenses from Allergan. Dr. Kilmer disclosed that she received research support from Miramar. Dr. Avram is a stockholder in Zeltiq.
GRAPEVINE, TEX. – A novel microwave device significantly reduced underarm sweating in two studies involving a total of 151 patients with axillary hyperhidrosis.
The condition affects millions of people, yet current treatments are limited by either duration of effect or efficacy. The microwave device has the potential for a longer-term and possibly even permanent effect via eradication of eccrine sweat glands, Dr. Suzanne L. Kilmer and Dr. Mark Lupin reported in separate presentations at the annual meeting of the American Society for Laser Medicine and Surgery.
The patient is shown before treatment. The dark areas show active sweat glands via a starch-iodine test.
Miramar Labs' miraDry system focuses microwave energy to selectively heat the interface between the skin and underlying fat, where the sweat glands reside. The system comprises a console, handpiece, and disposable tip. The in-office procedure takes approximately 40 minutes. The system was cleared for licensure in the United States by the Food and Drug Administration in January 2011, and will be marketed later this year, according to a company spokesperson.
Dr. Kilmer, of the Laser and Skin Surgery Center of Northern California, Sacramento, presented data on a second-generation version of the device that was FDA approved but never marketed. In a multicenter, sham-controlled study, 120 adults with hyperhidrosis were randomized to miraDry (81) or sham treatment (39) for one to three sessions. The patients had to have a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 ("my underarm sweating is barely tolerable and frequently/always interferes with my daily activities") at baseline, and gravimetric readings greater than 50 mg at each axilla (in 5 minutes).
The patient is shown with few active sweat glands 12 months after undergoing two miraDry treatment sessions.
Follow-up was 6 months for the sham group and 12 months for the treatment group. Responders were defined as subjects reporting a reduction to an HDSS score of 1 ("My underarm sweating is never noticeable and never interferes with daily activities") or 2 ("My underarm sweating is tolerable but sometimes interferes with daily activities"). The patients had a mean age of 33 years, 58% were female, and 84% were white.