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) in adults (use for anyone under 18 would be off-label and up to the clinician's discretion). Brella is a product of Candesant Biomedical, headquartered in Nashville, TN. This is the first new hyperhidrosis treatment that the FDA-ok'd since 2018.
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 (no more than 3 minutes but, depending on the patient, treatment could take less than 3 minutes) and works via a method called targeted alkali thermolysis (TAT). Depending on regulations in different U.S. states, Brella treatment may be provided by a physician, physician assistant, nurse practitioner or nurse.
Brella is oval shaped to fit the underarm and contains pure metallic sodium with zero aluminum. The patch itself is, according to Candesant, a "very standard, medical-grade adhesive patch."
Learn more! Watch our new "Ask Me Anything" video all about Brella with special guest Niquette Hunt, Candesant CEO.
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. No pain control or anesthesia is required prior, during, or after Brella.
About 48 or more hours before Brella treatment, patients should shave their underarms. In the office, prior to patch application, providers will ensure skin is dry. Once applied, the patch works through the interaction of its sodium with the water in sweat that begins to come out of the sweat glands. To stimulate sweating, if needed, clinicians are provided with a number of tips from the makers of Brella. Patients report that, during Brella treatment, they feel: "tingling," "prickles" or "pins and needles." The entire in-office visit to receive Brella treatment for both underarms is expected to take about 20 minutes. Results usually become apparent 3 to 5 days after treatment and 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 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. There were no lasting side effects and any side effects were transient and went away on their own.
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 (IHhS) “because they demonstrate consistent, statistically significant, and clinically meaningful improvements across the measured hyperhidrosis parameters.”
According to Candesant, Brella is available in certain areas of the U.S. as of mid 2023 through a “Brella Early Experience Program.” The initial healthcare offices able to provide Brella are dermatology and plastic surgery practices with prior experience treating patients with excessive sweating. In 2024, Brella will be launched more generally in the U.S. According to Niquette Hunt, CEO of Candesant, it will take a few years before Brella becomes available outside the U.S.
How much does Brella cost? Hunt says 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.
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. "We hope to study other focal areas," says Hunt, "but not in the next couple years because we are a small company."
To learn more, watch our "Ask Me Anything" video all about Brella with special guest Niquette Hunt, Candesant CEO.
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 links for relevant scientific research. Hopefully there will be further studies published soon.
Glaser D, Green L, Kaminer M, Smith S, Pariser D. Outcomes from the SAHARA clinical study on the TAT patch for excessive axillary sweating or primary axillary hyperhidrosis. Poster presented at the Music City SCALE 2023; May 17-21, 2023; Nashville, TN.
Jacob C, Green L. Quality of life improvement shown during SAHARA clinical study on the TAT patch for the treatment of primary axillary hyperhidrosis or excessive axillary sweating. Poster presented at the Cosmetic Bootcamp Summer Meeting 2023; June 22-25, 2023; Aspen, CO.
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