With the FDA’s approval of the first topical hyperhidrosis treatment in June this year, physicians treating excessive underarm sweating can offer patients a range of approved options, including Botox, MiraDry and soon Qbrexa.
Qbrexa (glycopyrronium, Dermira), which should be available for clinical use in October 2018, fills a gap in treatment options, according to Dee Anna Glaser, M.D., professor and interim chairman of dermatology at Saint Louis University School of Medicine and president of the International Hyperhidrosis Society.
Patients have to apply the prescription topical daily, but treatment doesn’t require regular injections or treatment with an energy device, according to Dr. Glaser.
“I think we have some great options, in addition to some of the older prescription antiperspirants, which can be beneficial but are oftentimes irritating to the surface of the skin,” Dr. Glaser said.
The FDA approved Qbrexa for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients nine years of age and older.
Two phase 3 studies, ATMOS-1 and ATMOS-2, compared use of the topical to vehicle in patients ages nine and older with primary axillary hyperhidrosis. The ATMOS-1 trial enrolled 344 patients at 29 sites in the United States and Germany and found nearly 53% of patients on Qbrexa achieved a four-point improvement or more with the Axillary Sweating Daily Diary in sweating severity, versus 28.3% of patients who received vehicle. More than 56% of patients treated with Qbrexa had at least a two-grade improvement from baseline according to the Hyperhidrosis Disease Severity Scale, compared to 23.7% in patients receiving the vehicle. Patients’ average reduction in sweat production was 104.9 mg in the treatment group, compared to 91.9 mg in vehicle-treated patients.
Qbrexa has been studied in pediatric patients, which is important because excessive underarm sweating usually starts in puberty and early adolescence, according to Dr. Glaser.
“In the Dermira trial, we didn’t see any significant difference in the response to the therapy in pediatric subjects compared to adult subjects, and we didn’t see any significant differences in side effects or inability to tolerate it because of their young age,” says Dr. Glaser, who was among the clinical trial investigators for the drug.
Qbrexa has an anticholinergic effect, so it’s contraindicated in some patients. Dry mouth, application site pain and mydriasis are among the most common adverse reactions. Eight of 229 patients treated with Qbrexa in ATMOS-1 withdrew from the trial because of adverse events, according to a June 1, 2016, Dermira press release.
MiraDry: One and Done
MiraDry (Miramar Labs) uses microwave technology to heat and destroy sweat glands within the axilla.
“There is enough heat to destroy some of the apocrine glands; although, to my knowledge, the microwave energy doesn’t specifically target the apocrine glands,” according to Dr. Glaser. “There’s also enough heat generated to destroy some hair follicles, but not enough to make a patient completely hair-free in the axilla. So, I warn everybody, for good or bad, that they’ll probably lose some hair follicles. If they want to continue that process, they’re best off with a hair removal laser.”
MiraDry is a one-time treatment that offers a permanent solution.
“I think patients really enjoy that aspect of it,” Dr. Glaser said. “But while there is significant improvement in the amount of sweat with treatment, I certainly don’t promise that someone would be sweat-free.”
Dr. Glaser’s patients generally describe outcomes from MiraDry treatment as a significant improvement in sweating, but they still sweat a little — more like a normal person would.
“For patients who have body odor as a concern, I let them know that MiraDry has been shown to offer some odor improvement,” she says.
Communicating clear patient expectations for this and other therapies is key to patient satisfaction, according to Dr. Glaser.
Among the potential drawbacks of MiraDry treatment: It’s not covered by health insurance. And patients generally need a day or two of rest, icing the area and taking over-the-counter pain relievers. Post-treatment, patients might have transient swelling, numbness in the treatment area that could last months, cysts, or local skin infections. Patients might need wound care if heat from the MiraDry device reaches too high a level. And, in rare cases, patients just don’t tolerate the procedure, which Dr. Glaser attributes, in part, to patient anxiety.
“All in all, MiraDry is an incredibly safe procedure,” she said.
MiraDry tends to be a good option for people who don’t have time for a regular office-based treatment or don’t want to have to use a daily topical. It’s also viable and cost-effective for people whose insurance might not fully cover other treatment options.
Dr. Glaser says she uses MiraDry to treat some teens with excessive sweating, although the FDA hasn’t approved the device for use in pediatric patients.
“A lot of my juniors and seniors in high school and freshmen in college really like the MiraDry treatment. It’s done. They don’t have to deal with their excessive sweating anymore,” she says.
Botox (onabotulinumtoxinA, Allergan) is anchored by extensive research showing its efficacy as a hyperhidrosis therapy; it’s generally safe and FDA approved, according to Dr. Glaser.
Still the injections aren’t for everyone.
Hyperhidrosis patients generally need Botox injections twice — sometimes three times — a year, according to Dr. Glaser.
“For some that’s perfect. The injection is done and over in five to 10 minutes, and they are good to go for the next six months,” she says. “Other patients don’t have the time or energy to come in to the office. They might be afraid of needles. Some people just are not big fans of botulinum toxin treatments.”
Patients who have Botox injections for hyperhidrosis might experience bruising and mild, temporary discomfort. It takes a couple days to the treatment to work, and it doesn’t always last the full six months.
For best results, physicians treating hyperhidrosis should listen carefully to patient concerns and take into account patients’ lifestyle and insurance coverage, Dr. Glaser says.