ORLANDO, Fla. — A novel topical therapy for axial hyperhidrosis approved by the FDA in June 2024 is among the increasing number of therapeutic options and new protocols for existing options to improve rates of therapeutic success.
The new topical agent — the anticholinergic sofpironium bromide gel — along with the targeted alkali thermolysis (TAT) patch approved in 2023 “may now be considered as first-line treatments,” said David Pariser, MD, a founding member of the International Hyperhidrosis Society (IHHS) and a professor of dermatology at Eastern Virginia Medical School, Norfolk.
Pariser participated in a symposium March 7 at the 2025 American Academy of Dermatology annual meeting.
The novel anticholinergic gel joins another topical anticholinergic, the glycopyrronium wipe (Qbrexza), which was approved several years ago for axilla hyperhidrosis. The gel is dispensed from a metered pump. The formulation is characterized as retrometabolic, which Pariser noted signifies rapid metabolization with the goal of “a better therapeutic effect with fewer systemic side effects.”
This might be true, but these advantages are speculative in the absence of a head-to-head comparison, according to Pariser. However, he suggested there is some evidence that the drugs differ, particularly in relative safety. Reviewing the pivotal clinical trials, called CARDIGAN-1 and CARDIGAN-2 for the sofpironium gel and ATMOS-1 and ATMOS-2 for glycopyrronium wipe, Pariser said that both provided significant and clinically meaningful objective reductions in sweat production when compared with vehicle, but at least some side effects appeared to be less frequent on the gel relative than the wipe relative vs vehicle alone in the cross-trial comparison.
For example, the reported incidence of several side effects was lower with the gel than the wipe relative: xerostomia (16.8% vs 24.1%), urinary hesitation/retention (3.7% vs 9.5%), xerophthalmia (2.0% vs 2.4%), and constipation (1.4% vs 2.0%), respectively. However, the incidence of blurred vision was higher with the gel (8.5% vs 3.5%), and the incidence of mydriasis was about the same (6.3% vs 6.8%).
In addition, skin reactions from active therapy relative to vehicle were much higher for sofpironium bromide (26.5% vs 2.7%) than for the glycopyrronium wipe (13.5% vs 9.9%) when compared across the pivotal trials.
Still, Pariser said these treatments are capable of reducing sweat production by up to 70%. While acknowledging that this amount of reduction, though substantial, might be insufficient for moderate to severe cases, he offered a clinical pearl for optimizing response with this agent and other topical antiperspirants, regardless of mechanism.
“Bedtime is the time to put on your antiperspirant, not when you wake up in the morning,” Pariser said. For over-the-counter (OTC) antiperspirants that reduce sweat by plugging the eccrine gland, or topical anticholinergic agents that require absorption to function, a morning shower washes away the active ingredients, Pariser said. Bedtime application is best for both, even if deodorants are more effective when applied after a morning shower.
Pariser encouraged clinicians to explain to patients the differences between deodorants (concealing odor), OTC antiperspirants (active ingredient blocking sweat gland excretion), and clinical-strength antiperspirants such as anticholinergics (active ingredient inhibiting sweat production).
The TAT patch is an option that dermatologists should consider for more significant hyperhidrosis. The single-use patch is applied to the axilla when it is dry. The active ingredient, sodium, interacts with sweat to produce thermal energy that impairs sweat gland function. If the patch is applied when wet, thermal energy is not generated when it can provide a therapeutic effect. If the patch is used properly, however, hidrosis control can persist for up to 3 months, according to Pariser.
Microwave thermolysis, a potential cure for hyperhidrosis, has been available for axilla hyperhidrosis for nearly 15 years and, more recently, to treat hyperhidrosis produced by other sweat glands — but a recent twist is a protocol that saves time, according to dermatologist Daniel Tinker, MD, who trained at Saint Louis University School of Medicine; he is now in private practice with Deluxe Dermatology in St. Louis.
When delivered at the appropriate depth and dose, microwave thermolysis eradicates eccrine glands, apocrine glands, and cells involved in odor production, according to Tinker. He reported that these cells do not regenerate, so this treatment is capable of permanently eliminating hyperhidrosis.
To avoid repeat treatments, which have been common with the approved protocol, Tinker worked with Dee Anna Glaser, MD, an adjunct professor in dermatology at Saint Louis Med, to develop a protocol with a higher-than-standard volume of anesthesia. By doing this, energy levels can be increased to induce a deeper clinical response with comparable safety.
“We were able to achieve an adequate effect in one session in 90% of patients without any difference in pain scores,” Tinker noted.
Like microwave thermolysis, many of the therapies initially approved to treat sweat glands in the axilla are being applied to other areas of the body. Although not all of the options are approved for use beyond the axilla, the list includes topical anticholinergics, botulinum injections, and iontophoresis.
Used judiciously, these therapies are allowing clinicians to address an array of unmet needs, such as palmar involvement, according to Pariser. In the case of iontophoresis, he noted that many devices on the market have variable features and characteristics designed for effective use in different anatomical areas.
Glaser made the same point when reviewing the growing number of botulinum toxins available for injection. The first US Food and Drug Administration approval of drugs in this class for treatment of hyperhidrosis dates back to 2007, but Glaser contended that newer options mean more choices, and she offered some ideas for improving results.
One of these is to assess how hyperhidrosis is adversely affecting the patient, using tools such as the Hyperhidrosis Disease Severity Scale (HDSS). With a baseline established, patients and physicians are better equipped to evaluate a response. She also advocated for use of the starch-iodine study, a classic and inexpensive approach to documenting the presence of hidrosis and its resolution. Glaser uses this routinely to guide botulinum toxin injections and confirm treatment efficacy.
Even patients who respond to therapies for a chronic problem might still need additional help, and Glaser offered a clinical pearl. For patients with event-related hyperhidrosis, such as episodes induced by a job interview or a speaking engagement, she suggested that a targeted dose of a drug with an anxiolytic property can help.
Of these, she said she often turns to propranolol, which slows the heart rate. She cautioned that a test dose is essential, given the risk of unexpected reactions — including some reduction in cognitive performance — but she said many patients find it helpful.
“Patients may want to start using this daily,” she said, adding that it is best reserved for event-related hyperhidrosis only. “I find the effect diminished with repeated doses.”
Pariser has financial relationships with Novartis, Pfizer, Regeneron, and Sanofi. Glaser has financial relationships with Beiersdorf, Benev, Biofrontera, Candesant Biomedical, Ferndale, La Roche-Posay, and Procter & Gamble. Tinker reports no relevant financial relationships.
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Publish date : 2025-03-09 15:00:00
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