NEW ORLEANS – , results from a pivotal randomized trial showed.
“This is a new kind of device that is going to be a nice tool to have for treating patients who have hyperhidrosis of the axilla,” the study’s lead investigator, David M. Pariser, MD, who practices dermatology in Norfolk, Va., said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology.
Dr. David M. Pariser
In a study known as SAHARA, investigators at 11 sites evaluated the efficacy of the targeted alkali thermolysis (TAT) patch, a single-use disposable device. The patch consists of a thin sodium layer on an adhesive overlay. It’s applied to the dry axilla, and as the patient sweats during treatment, the sweat reacts with the sodium. According to Dr. Pariser, this interaction generates precisely targeted thermal energy that targets sweat glands, leading to a reduction in excessive sweat production for up to three months.
The researchers enrolled 110 individuals with Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4 and randomized them to either an active TAT or a sham patch for up to 3 minutes. Their mean age was about 33 years, and slightly more than half were women. “If significant discomfort or pain was noted, [the patch] treatment was halted; otherwise, it was left on for 3 minutes,” said Dr. Pariser, professor of dermatology at Eastern Virginia Medical School, Norfolk. “The treated area was thoroughly cleaned after treatment, and the TAT patch was deactivated. This process was repeated on the other axilla.”
The HDSS, Gravimetric Sweat Production (GSP), and quality of life assessments for bother and impact were measured through 12 weeks. The quality of life assessments were an exploratory endpoint and scored from 0 to 4, with 4 being extremely bothered or impacted and 0 not being bothered or impacted at all. The primary efficacy endpoint was the proportion of treated patients achieving a 1 or 2 on the HDSS at week 4, compared with sham treatment.
Secondary endpoints included the proportion of patients with an improvement of at least 2 grades from baseline to 4 weeks in HDSS by treatment group; mean improvement in the quality of life scale bother by treatment group; mean improvement in the quality of life scale impact by treatment group; and the proportion of subjects with at least 50% improvement in GSP from baseline to 4 weeks in the active patch group only.
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Adverse events (AEs) were divided into 3 categories: AEs at the treatment site (or skin reactions within the treated part of the axilla); procedure-related AEs (those that are the result of treatment, but not in the treated part of the axilla), and non-axillary AEs.
Dr. Pariser reported that at 4 weeks, 63.6% of patients in the active patch group versus 44.2% of those in the sham group improved to an HDSS score of 1 or 2 (P = .0332) and that 43.2% of those in the active patch group versus 16.3% of those in the sham group (P = .0107) achieved a 2-point or greater HDSS improvement. In addition, 9.1% of those in the active patch group achieved a 3-point improvement on the HDSS, compared with none in the sham group. “That’s an amazing improvement; you’re basically going from moderate or severe to none,” he commented.
In other findings, 60.5% of patients in the active patch group showed at least a 50% reduction in GSP, compared with 32.6% of those in the sham group (P = .0102), with mean reductions of 57.3 mg/5min and 18.2 mg/5min, respectively (P = .0036). As for quality-of-life outcome scores, bother associated with hyperhidrosis was reduced by 1.52 points in active versus 0.61 in sham subjects (P = .0005), while impact was reduced by 1.44 in active versus 0.57 in sham subjects (P = .0004).