Brella™ SweatControl Patch™
In April 2023, the U.S. FDA cleared for use the Brella™ SweatControl Patch™ for the treatment of excessive underarm sweating (primary axillary hyperhidrosis). Brella™ is a product of Candesant Biomedical, headquartered in San Francisco, CA.
The Brella™ patch is a prescription product designed and cleared to be applied at a healthcare provider’s office or clinic for approximately 3 minutes and works via a method called targeted alkali thermolysis (TAT).
Candesant’s TAT technology is based on the principle that heat is generated when sodium meets water. The result is that when the Brella™ sodium patch is applied to the underarm, there’s an interaction between the water in sweat and the sodium in the patch that generates a targeted amount of heat, causing microthermal injury to the sweat glands that inactivates those glands for a period of time. The process is non-invasive and does not involve needles. Results have been reported to last 2 to 4 months.
The FDA’s clearance of Brella™ was based on data from a randomized, double-blind, multicenter study that included 110 adult patients with primary axillary (underarm) 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 in the study then received treatment with Brella™ or with a sham (fake or placebo) patch for up to 3 minutes on each underarm. Afterwards, patients were evaluated weekly for 12 weeks (~3 months), and again at 24 weeks (~6 months) post-treatment.
Results were presented, earlier in 2023, at the American Academy of Dermatology Annual Meeting and showed that 64% of patients treated with the patch achieved Hyperhidrosis Disease Severity Scale improvement as compared with 44% with placebo. Measured sweat production decreased by more than 50% for most (60%) of treated patients.
There were no reported serious or severe adverse events (side effects) among the study participants. Eighty percent of people in the study had no side effects at all and those who did experienced slight redness or slight swelling that resolved within two weeks or less.
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 the late summer of 2023 through a “Brella Early Experience Program.” The initial healthcare offices able to provide Brella™ through this program will be dermatology and plastic surgery practices with prior experience treating patients with excessive sweating. Later, Brella™ will be launched more generally in the U.S. Information about availability outside the U.S. is not yet available.
Have you talked to a healthcare provider about excessive sweating? If not, now is the time! Our Clinician Finder can help you locate practitioners who treat hyperhidrosis. Use it today! A knowledgeable healthcare team can help you to find the right treatment, or combination of treatments, to manage your hyperhidrosis.
You may also want to consider participating in a clinical trial. Patients enrolled in clinical trials often receive treatments free of charge. Visit our Active Research page to find out more.
And remember, because hyperhidrosis is a serious medical condition - you deserve insurance coverage and reimbursement for your medical visits and treatments. We've got tips to help you navigate the health insurance realm; visit Insurance Tools for more information.
Research and References
Ready to learn more about Brella™ for the treatment of excessive sweating? See the below link for relevant scientific research. Hopefully there will be further studies published soon.
Kaufman J, Green JB, Cazzaniga A, Canty DJ, Tims E, Waugh J. A Pilot Study of the Safety and Effectiveness of a Novel Device in Subjects With Axillary Hyperhidrosis. Dermatol Surg. 2022 Nov 1;48(11):1220-1225. doi: 10.1097/DSS.0000000000003598. Epub 2022