According to Dr. Mark Nestor, a dermatologist and voluntary associate professor of dermatology at the University of Miami Miller School of Medicine, ultrasound treats axillary hyperhidrosis by heating and destroying sweat glands – so that they can no longer produce perspiration. Nestor reported to the American Academy of Dermatology that sweating was reduced by 80% after two ultrasound treatments given 28 days apart. The patients in the study were followed for two months post-treatment. Adverse events included temporary tenderness, redness, numbness, and bruising. Nestor received a research grant for the study from Ulthera.
(Please note: the device discussed in this article – Ulthera - is separate and distinct from the medical device miraDry, which was FDA-cleared to treat excessive underarm sweating in 2011.)
The Ulthera study was small, the patients involved were followed for a relatively short time post-treatment, and the findings have not yet undergone the "peer review" process, in which outside experts scrutinize the data prior to publication in a medical journal. Additional studies are anticipated and, hopefully, will provide more evidence regarding the safety and efficacy of this treatment.
International Hyperhidrosis Society board member Dr. Ada Regina Trindade de Almeida (Dermatologic Surgeon, Hospital do Servidor Público, Municipal de São Paulo, Brazil) and Dr. Andrei Metelitsa (Clinical Assistant Professor, Division of Dermatology, University of Calgary Co-Director, Institute for Skin Advancement) both reiterate that the ultrasound study was small and isolated. So far, there is little data to base a decision on, they say. They also note that the ultrasound device, Ulthera, is FDA-cleared for cosmetic non-invasive face-lifts, but that a hyperhidrosis use is "off-label." (Off-label treatments are not uncommon. For instance, oral medications can be used off-label to treat hyperhidrosis safely and effectively.)
Ultrasound energy has been in use in the field of medicine for more than 50 years. The FDA cleared the Ulthera device in 2009 for non-invasive tissue lift. The device uses ultrasound energy to heat tissues under the skin and it is believed that this heat energy either destroys or disables the sweat glands. But, further research is needed to determine its specific method of action in terms of sweat reduction and the longevity of its effects. We await peer-reviewed, large-scale, long-term studies of Ulthera and will report on those studies as soon as they become available.
One of the local physicians and a friend of the IHHS, Annie Buinewicz, MD shares her opinion, "Ulthera is FDA-approved for skin tightening and lifting of the face and neck area. We are very happy to offer this to our patients. The procedure is FDA-approved in the US for two years now, and over six years internationally. The Ulthera equipment is cost-prohibitive for many offices, but it is most common among cosmetic medical practices."
"In my opinion, one can very easily learn and become comfortable with the off-label use and technique of Ulthera as an axillary hyperhidrosis treatment. Research is still being conducted as to this treatment's application to hyperhidrosis, specifically whether the treatment works and whether it works in the long-term. I'll be looking forward to reviewing that research when it becomes available."
In the meantime, remember that while medical devices are relatively new in the arena of underarm hyperhidrosis treatment, iontophoresis medical devices have been used to treat palmar and plantar (hand and foot) sweating since the 1940s. Depending on the body area affected, treatment options vary greatly – need a refresher on your options? Check out our updated algorithms.