Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
The Food and Drug Administration (FDA) has cleared the Brella 3-Minute Sweat Control Patch™ for the reduction of excessive underarm sweating in adults with primary axillary hyperhidrosis.
The single-use disposable patch consists of a sodium sheet with an adhesive overlay that is applied to a patient’s underarm by a health care provider for up to 3 minutes. The clearance was supported by data from the randomized, double-blind, sham-controlled, multicenter, SAHARA study (ClinicalTrials.gov Identifier: NCT04599907), which included 110 adults with primary axillary hyperhidrosis who had baseline Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4. Patients received bilateral treatment with Brella or a sham patch for up to 3 minutes for each underarm, and were evaluated weekly for 12 weeks post-treatment.
Results showed a greater proportion of patients treated with Brella improved HDSS scores to 1 or 2, indicating their sweating never or sometimes interfered with daily activities, compared with those who received sham treatment (primary endpoint; 64% vs 44%; P =.0332). Additionally, 43% of Brella-treated patients achieved a 2-point or greater improvement in HDSS compared with 16% of sham-treated participants (P =.0107).
Treatment with Brella also resulted in significant reductions in gravimetric sweat production and improvements in quality of life. No serious or severe adverse events were reported with treatment.
“FDA clearance of Brella represents a significant advance for 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,” said Niquette Hunt, Founder and CEO of Candesant. “[…] 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.”
Brella is expected to be available in select US markets through the Candesant Brella Early Experience Program beginning late summer of 2023.
References:
- Candesant Biomedical receives FDA clearance of Brella™, the first and only 3-Minute SweatControl Patch™, to significantly reduce primary axillary hyperhidrosis (excessive underarm sweating). News release. Candesant Biomedical. April 13, 2023. https://www.multivu.com/players/English/9159151-candesant-biomedical-receives-fda-clearance-of-brella/.
- Pivotal clinical SAHARA study shows Candesant Biomedical’s investigational sweat control patch significantly reduces primary axillary hyperhidrosis (excessive underarm sweating). News release. Candesant Biomedical. March 18, 2023. https://www.prnewswire.com/news-releases/pivotal-clinical-sahara-study-shows-candesant-biomedicals-investigational-sweat-control-patch-significantly-reduces-primary-axillary-hyperhidrosis-excessive-underarm-sweating-301775569.html.
