A once-daily topical gel significantly reduced symptoms of underarm sweating and improved patient-reported outcomes in individuals with primary axillary hyperhidrosis, based on pooled results from two randomized, double-blind, phase 3 clinical trials in the United States.
The trials assessed the efficacy and safety of sofpironium gel, 12.45%, in 701 participants aged 9 years and older. Subjects were randomized to receive either the active treatment or a vehicle gel, applied nightly to the underarms for 6 weeks. Outcomes were evaluated using both a patient-reported severity scale and objective sweat volume measurements.
Of the total participants, 353 received the active treatment and 348 received the vehicle. Baseline characteristics were similar across groups. The median age was 31 years, and most participants had experienced symptoms for over a decade.
Symptom changes were measured using the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax-7), a validated 7-item scale. By the end of treatment, 84.6% of participants in the treatment group achieved at least a 1-point improvement, compared with 72.3% in the vehicle group. A ≥2-point improvement was also significantly more common in the treatment group.
Sweat volume was assessed using gravimetric sweat production (GSP), which measures sweat in milligrams over 5 minutes. Participants receiving the active gel showed significantly greater reductions in sweat volume than those receiving the vehicle. Improvements were evident by the first week of treatment and maintained throughout the 6-week period.
Additionally, 38.2% of treated participants achieved both a ≥2-point improvement in HDSM-Ax-7 and a ≥70% reduction in GSP, compared with 17.7% in the control group. A lower composite threshold—≥1-point HDSM-Ax-7 improvement and ≥50% GSP reduction—was reached by 62.8% in the treatment group versus 45.3% in the control group.
The treatment was generally well-tolerated. Approximately 32% of treated participants experienced treatment-related adverse events (AEs), most commonly dry mouth, blurred vision, application site pain or irritation, and pupil dilation (mydriasis). Most AEs were mild to moderate and resolved within a median of 4 to 21 days. Severe AEs occurred in 2.5% of participants, and 4% discontinued treatment due to AEs. No serious treatment-related events were reported.
Anticholinergic-related side effects were reported in 20% of the treatment group. Subgroup analysis showed no significant differences in AE incidence by age, sex, or race.
Although the study duration was limited to 6 weeks, a separate long-term open-label phase 3 study previously demonstrated sustained efficacy and tolerability over 48 weeks.
Sofpironium gel may offer a noninvasive treatment option for managing primary axillary hyperhidrosis, a condition that affects nearly 5% of the U.S. population, particularly for patients who have not responded well to existing therapies.
Full disclosures can be found in the published study.