WASHINGTON, DC — An investigational anticholinergic topical gel is safe and effective for the treatment of axillary hyperhidrosis, according to results from a phase 2b study.
Sofpironium bromide (BBI-4000, Brickell Biotech) is one of several topical products currently being investigated in clinical trials, said David Pariser, MD, professor of dermatology at the Eastern Virginia Medical School in Norfolk, who is founding president of the International Hyperhidrosis Society.
The product is a specially formulated “soft” topical anticholinergic designed to block sweat production, and its rapid metabolic deactivation and excretion reduces the adverse effects associated with anticholinergic agents, such as dry eye and dry mouth.
“BBI-4000 is quickly metabolized, so it may be less likely to cause these anticholinergic effects,” Dr Pariser told Medscape Medical News. “We’ll know for sure when we see the much larger phase 3 trial data, but phase 2 looks good, and the rates of those side effects are low.”
“It really appears to be a very safe and effective means of controlling sweating,” said session moderator Sandy Sharon Tsao, MD, from the Massachusetts General Hospital in Boston.
Hyperhidrosis can severely affect patients’ lives. “It is so devastating for people. They have to wear black clothing, have to carry multiple shirts, and really are limited and feel constricted in education, jobs, and relationships,” Dr Tsao pointed out.
Current treatments for axillary hyperhidrosis include antiperspirants, which aren’t very effective, and more invasive therapies, such as onabotulinumtoxin A (Botox, Allergan) injections and the microwave-based MiraDry system (Miramar Labs), she explained.
BBI-4000 involves minimal discomfort and patients can apply it at home. “If it’s just as effective, it will be a wonderful treatment option,” Dr Tsao said.
Dr Pariser presented the study results during a late-breaker session here at the American Academy of Dermatology 74th Annual Meeting.
Efficacy With Few Anticholinergic Effects
In the multicenter, double-blind, randomized, vehicle-controlled, dose-ranging study, 189 patients with primary axillary hyperhidrosis were randomized to BBI-4000, in 5%, 10%, or 15% concentrations, applied at bedtime daily for 28 days or to vehicle gel.
At baseline, all patients had a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4, and produced at least 50 mg of sweat in each axilla over 5 minutes.
In an intent-to-treat analysis, an improvement of at least 2 points on the HDSS at day 29 was achieved by significantly more patients treated with BBI-4000 15% than with placebo (38.3% vs 12.2%; P < .01).
On the Hyperhidrosis Disease Severity Measure Axillary (HDSM-Ax), a reduction of at least 1 percentage point was achieved by more patients treated with BBI-4000 15% than with placebo (72.3% vs 43.9%; P = 0.01). The same was true for a reduction of at least 2 percentage points (44.7% vs 19.5%; P = 0.01).
On Dermatology Life Quality Index (DLQI) scale, where a higher score indicates greater impairment, the dose-related decrease was 8.1 points with BBI-4000 15%, 5.8 points with BBI-4000 10%, 5.8 points with BBI-4000 5%, and 5.2 points with placebo.
On the measure of gravimetrically assessed sweat reduction, there was a trend toward significance for the gel, compared with placebo (P > .05). However, when a reduction of at least 1 percentage point on the HDSM-Ax was combined with a reduction of at least 50% in sweat production by day 29, BBI-4000 15% was significantly better than placebo (48.9% vs 26.8%; P = .03).
Topical irritation was infrequent. Localized dermatitis occurred in 6.1% of BBI-4000 patients, pain occurred in 2.6%, and pruritus occurred in 1.6%, but these effects weren’t dose-related. All were mild or moderate and resolved spontaneously.