The U.S. Food and Drug Administration (FDA) recently cleared Candesant Biomedical’s Brella™, a three-Minute SweatControl Patch used for the treatment of primary axillary hyperhidrosis in adults.
Brella is a single-use disposable sodium patch that uses Candesant’s patented TAT (targeted alkali thermolysis) technology. The patch is applied to the patient’s underarm for approximately three minutes. When the sodium on the patch comes into contact with the water in the patient’s sweat, thermal energy is generated. This heat is highly localized to micro target sweat glands, therefore reducing overall sweat production. The treatment takes place in-office, is noninvasive, needle-free, and provides relief for up to three or four months.
FDA’s clearance of Brella is based on data from the pivotal SAHARA study, a randomized, double-blind, sham-controlled study of 110 adults with primary axillary hyperhidrosis. Participants in the study had a baseline Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4. This meant that their sweating frequently or always interfered with their daily activities.
During the study, participants underwent bilateral treatment with either Brella or a sham patch for up to three minutes under each arm. They were evaluated weekly for 12 weeks post-treatment with responders followed for up to 24 weeks post-treatment. Results of the study indicated that it reached both its primary and secondary endpoints, a reduction in sweating and an improved quality of life. Furthermore, results indicated that the treatment was well-tolerated with no serious adverse events.
News of Brella’s clearance has been welcomed by patients and health care professionals alike and has been dubbed a “game changer” by the International Hyperhidrosis Society. Not only does it offer an easy-to-use and safe treatment, but it also brings hope for improved quality of life. For people who suffer from hyperhidrosis, their problems are not limited to the physical complications that arise from excessive sweating, such as skin irritation and infections. Unfortunately, as with many other conditions, they are also more prone to emotional and psychological issues, including depression and social isolation.
Board-certified dermatologist and clinical associate professor of dermatology at the New York University Langone Medical Center, Doris J. Day, MD, states, “Brella provides an easy conversation starter for us health care providers and our patients because it provides a simple, in-office approach to sweat control that is fast, comfortable, non-invasive, needle-free, aluminum-free, and affordable, and with results lasting 3 to 4 months.”