March 18, 2023
2 min read
Pariser DM. Outcomes from the SAHARA clinical study on the TAT patch for excessive axillary sweating or primary axillary hyperhidrosis. Presented at: American Academy of Dermatology Annual Meeting; March 17-21, 2023; New Orleans.
Pariser reports serving on the data safety monitoring board for BMS and being a consultant and/or investigator for Bickel Biotechnology, Biofrontera AG, Celgene Corporation, Novartis Pharmaceuticals Corp., Pfizer Inc., Regeneron and Sanofi.
- The targeted alkali thermolysis patch reduced hyperhidrosis disease severity in 64% of patients.
- No serious adverse events were reported at any time in any subjects.
NEW ORLEANS —The targeted alkali thermolysis patch was safe and effective in the treatment of excessive axillary sweating or primary hyperhidrosis in adults, according to data presented at the American Academy of Dermatology Annual Meeting.
One-third of adults in the United States suffer from excessive sweating, with approximately 5% having hyperhidrosis, according to the presentation abstract. The targeted alkali thermolysis (TAT; Candesant Biomedical) patch may offer a new treatment option for patients suffering from this condition.
“SAHARA findings support the results of a pilot study published in the November 2022 print issue of Dermatologic Surgery,” David Michael Pariser, MD, FACP, FAAD, professor in the department of dermatology at Eastern Virginia Medical School, cofounder of Virginia Clinical Research and one of the study’s lead investigator, told Healio.
David Michael Pariser
“That study also showed the TAT patch produced statistically significant improvements in [Hyperhidrosis Disease Severity Scale (HDSS)], the amount of sweat production, and levels of bother and impact,” Pariser, who is also a past president of the American Academy of Dermatology and founding member of the International Hyperhidrosis Society, said.
Pariser presented data from this double-blind, sham-controlled, multicenter pivotal trial evaluating the safety and efficacy of the TAT patch in 110 adults with severe hyperhidrosis, categorized as a HDSS score of 3 or 4.
Participants were treated with either an active TAT patch or a sham patch for up to 3 minutes. Researchers measured HDSS, gravimetric sweat production (GSP) and quality of life assessments for bother and impact through 12 weeks.
By week 4, 64% of TAT-treated patients reduced their HDSS score to 1 or 2 compared with 44% of sham-treated patients (P = .0332). TAT-treated patients also saw significantly more success in achieving a 2-point HDSS improvement from baseline compared with sham-treated patients (43.2% vs. 16.3%; P = .0107).
A GSP reduction of more than 50% was achieved in 60.5% of treated patients, with a mean GSP reduction of 57.3 mg per 5 minutes in the treatment group vs. 18.2 mg per 5 minutes in the sham group (P = .0036).
Quality of life assessments showed that the TAT patch outperformed sham treatment. Bother was reduced by 1.52 in TAT-treated patients compared with 0.61 in sham-treated patients (P = .0005). Similarly, TAT-treated patients reported a reduced Impact of 1.44 compared with 0.57 among the sham group (P = .0004).
No serious adverse events were reported, and most mild to moderate adverse events resolved within 2 weeks.
“The findings at 4 weeks showed the TAT patch produced significantly greater improvements in all efficacy measures compared to the sham patch,” Pariser told Healio. “If the FDA clears the TAT patch, it will be a welcome addition to our armamentarium of treatments for both providers and patients for treatment of primary axillary hyperhidrosis or excessive underarm sweating.”