The FDA is feeling the heat. Just in time for summer, the agency has cleared an adhesive patch from Candesant Biomedical that’s designed to reduce excessive underarm sweating for several months after just a few minutes of wear.
The Brella SweatControl Patch is meant to serve as an alternative, noninvasive solution to excessive sweating, which is currently treated by prescription antiperspirants, wipes and creams as well as medications used to block nerves or as antidepressants and repeated Botox injections, according to the Mayo Clinic.
The sodium patch has been cleared to treat adults with primary axillary hyperhidrosis, a condition that causes excessive underarm sweating that may not always be linked to heat or exercise. Estimates cited by Candesant suggest that while about 15 million Americans report having hyperhidrosis, the condition may actually be much more widespread, since the condition often goes unreported and therefore undiagnosed.
The FDA clearance will bring the patch to the “millions of people dealing with the physical, emotional, financial and aesthetic impact of hyperhidrosis, or sweating beyond what’s needed to keep the body cool,” Niquette Hunt, founder and CEO of Candesant, said in the company’s Thursday announcement.
“Satisfaction with current treatments is low, and 80% of consumers are seeking new treatments to manage excessive underarm sweat,” Hunt said. “Brella provides a new option for a common condition that curtails activities, stains clothes, causes frustration and embarrassment, undermines confidence and has been inadequately treated for far too long.”
The Brella patch’s U.S. launch will begin toward the end of summer this year, with Candesant offering it up to aesthetic practices in certain areas of the country through an “early experience program.” From there, it’ll expand across the country in a full national rollout, per the announcement.
Doctors apply the adhesive patch to patients’ underarms for up to three minutes during an in-clinic visit. The treatments rely on what Candesant has termed its targeted alkali thermolysis (TAT) technology: According to the company, because heat is generated when sodium comes into contact with water, when the water found in sweat droplets hits the sodium patch, the resulting chemical reaction creates a burst of thermal energy.
That energy is then directed back toward the ducts from whence the sweat came, delivering a “micro-thermal injury” to the sweat ducts, with an aim of deactivating the sweat glands for several weeks.
A recent study of the Brella patch recruited 110 adults with excessive underarm sweating, each of whom was treated with either the sodium patch or a sham patch on both underarms. By four weeks after the treatment, 64% of those who’d received the Brella patch reported that their scores on the four-point Hyperhidrosis Disease Severity Scale (HDSS) had dropped to a 1 or 2—from a starting point of 3 or 4—compared to 44% of those in the control group. In total, more than 40% of Brella users saw their HDSS scores drop by at least two full points, while only 16% of the sham patch users saw the same rate of improvement.
Looking at actual sweat production, the Brella group saw an average reduction of 57 milligrams of sweat produced during a five-minute period, compared to a drop of just 18 milligrams of gravimetric sweat production for the control group.
According to Candesant, people treated with the Brella patch have seen the sweat reductions last about three months and even longer for some users.