Targeted alkali thermolysis patch effective, well tolerated in axillary hyperhidrosis
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Candesant Biomedical announced positive results from its pilot study on the targeted alkali thermolysis patch, an investigational treatment for patients with axillary hyperhidrosis, according to a company press release.
The results published in Dermatologic Surgery showed that the new investigational targeted alkali thermolysis (TAT) patch was effective and well tolerated in patients with excessive underarm sweat.
“This is the first published clinical study on our TAT patch technology, and it supports its potential as a treatment option for people with primary axillary hyperhidrosis, commonly known as excessive underarm sweating,” Niquette Hunt, president and CEO of Candesant Biomedical, told Healio. “It is the first reported clinical application of alkali-metal (sodium) thermolysis and is the only patented medical device based on it.”
The study included 16 adults with Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4. Each participant was treated with the TAT patch or a sham patch for up to 3 minutes and evaluated weekly for 6 weeks post-treatment.
The primary efficacy measure — improved HDSS at week 4 — was met by 83% of participants treated with the TAT patch and no participants treated with the sham patch. Further, by week 6, 86% of TAT-treated participants reported a 1- or 2-point decrease of HDSS scores compared with 14% of sham-treated participants. Also, significantly more of those treated with TAT vs. sham experienced a 50% or greater reduction in sweat produced (66.7% vs. 14.3%).
As an exploratory endpoint, subjects were instructed to score their quality of life on a scale of 0 (not bothered or impacted) to 4 (extremely bothered or impacted). By week 6, TAT-treated participants reported low bother and impact (0.71 and 1.14, respectively) compared with sham-treated participants (3.29 and 3.43).
“The study findings open the door for additional clinical trials in axillary hyperhidrosis, and in the future for studying the potential of the TAT technology on other locations of excessive sweating, such as palms, the face and soles of the feet,” Hunt said. “If cleared, the TAT patch would provide physicians with a new treatment approach that is quick, convenient, tolerable, and durable.”