Brella™
Brella™ SweatControl Patch™
In April 2023, the U.S. FDA cleared for use the Brella™ SweatControl Patch™ for the treatment of primary axillary hyperhidrosis. Brella™ is a product of Candesant Biomedical, San Francisco, CA. It's the first new hyperhidrosis treatment since 2018.
Brella™ is cleared to be applied by a healthcare provider for approximately 3 minutes and works via targeted alkali thermolysis (TAT). TAT technology is based on the scientific principle that heat is generated when sodium meets water. The result is that when the Brella™ patch is applied to the underarm, there’s an interaction between the water in sweat and the sodium in the patch to generate a targeted amount of heat, causing microthermal injury to the sweat glands that inactivates those glands for a period of time. Results have been reported to last 2 to 4 months.
The FDA’s clearance of Brella™ is based on data from SAHARA (NCT04599907), a randomized, double-blind, sham-controlled, multicenter pivotal study that included 110 adult patients with primary axillary hyperhidrosis. Patients had baseline Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4, which showed that excessive sweating frequently or always interfered with their daily lives. Patients then received bilateral treatment with Brella™ or with a sham patch for up to 3 minutes on each underarm. Afterward, patients were evaluated weekly for 12 weeks post-treatment, with responders followed for up to 24 weeks post-treatment.
Primary endpoints of the SAHARA study included the occurrence of adverse events and skin reactions following patch treatment (2-week time frame) and achievement of an HDSS score of 1 or 2 (4-week time frame). Key secondary endpoints included a mean improvement in quality of life and the proportion of treated subjects with at least 50% improvement in Gravimetric Sweat Production (GSP) from baseline to 4 weeks. Eligible patients were aged 22 years or older with GSP greater than 50mg per axilla.
Brella™ was well tolerated among patients with no reported serious or severe adverse events. Data from the SAHARA study was presented in a late-breaking oral presentation at the 2023 American Academy of Dermatology Annual Meeting.
The Brella™ study results “are exciting,” says Dr. David Pariser, professor at the Eastern Virginia Medical School Department of Dermatology and founding member of the International Hyperhidrosis Society, “because they demonstrate consistent, statistically significant, and clinically meaningful improvements across the measured hyperhidrosis parameters.”
According to Candesant, Brella™ will be available in certain areas of the U.S. in mid 2023 through a “Brella Early Experience Program.” The initial healthcare offices able to provide Brella™ through this program will be aesthetic practices with prior experience treating patients with excessive sweating. Later in 2023, Brella™ will be launched more generally in the U.S. There is a MyBrella.com clinician finder for patients to use and Brella-providing practitioners to join. Patients and HCPs can also join Candesant's mailing list for updates on Brella's rollout.
How much will it cost? That's not entirely clear but Niquette Hunt, CEO Candesant has said she expects doctors will charge about the same for one session with the patch as they would for a high-end, in-office facial or chemical peel. The average cost of a chemical peel in the US, according to the American Society of Plastic Surgeons, is about $500. But, there can be additional office visit costs, etc. IHhS spoke with one aesthetic practice in Texas that indicated they would provide Brella for a total cost of about $350. This is, of course, just one example and not indicative of widespread pricing.
Information about availability outside the U.S. is not yet available.
Can Brella be used on other sweaty body areas beyond the underarms? Some experts hint there may be off-label potential for the use of Brella on different body parts. The makers of Brella say they are looking into this possibility.
To learn more about Brella™, see the below link to relevant research. Hopefully there will be further peer-reviewed studies soon.