Systemic Review Further Confirms Sofpironium’s Safety and Efficacy in Hyperhidrosis Treatment

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An evidence-based, systemic review confirmed the efficacy and safety of sofpironium bromide topical gel as a therapeutic option for patients with primary axillary hyperhidrosis.¹ Investigators in the included literature saw notable improvements in disease severity, sweat reduction, and quality of life.

The study included peer-reviewed international journals published up to July 2024 in PubMed, Scopus, and Embase databases. The Cochrane Risk of Bias Assessment tool and Newcastle-Ottawa scale evaluated the quality of each study. No risk of bias was found. 

The initial search yielded 117 manuscripts, but 5 studies were selected for a full-text screening. Moreover, 3 were double-blind, randomized control trials, 1 was a prospective observational study, and 1 was a retrospective case study. Only 3 studies utilized vehicle control groups.

This created a total of 752 patients between the ages of 13 and 72. One study used 5%, 10%, and 15% sofpironium while the rest used 5%. There was a wide scope of follow-up periods, ranging from 6 to 53 weeks. Each piece of research assessed the total gravimetricweight of sweat, the Hyperhidrosis Disease Severity Measure-Axillary score (HDSM-Ax score), the Hyperhidrosis Disease Severity Scale (HDSS), and the Dermatology Life Quality Index (DLQI).

At baseline, participants had a severe disease severity with an HDSS score between 3 and 4. Over 50% of patients reached an HDSS score of 1 or 2 after sofpironium treatment. These groups also had a 50% or higher decrease in the total gravimetric weight of sweat.

Additionally, the average HDSM-Ax score was greatly reduced in patients who used sofpironium. 2 studies found a statistically significant improvement of 1.5 or more while 1 study measured a statistically significant ≥ 1 or ≥2-point improvement. In another study, this decrease in HDSM-Ax score occurred from baseline to week 6 and then remained the same until the conclusion of the trial (week 52).

There was also a notable reduction in average DLQI score of those using sofpironium compared to the vehicle. In one of the studies, 94% of patients with low HDSS scores also had improved DLQI scores (p < 0.001). However, another reported that the DLQI score stayed the same throughout the long term.

None of the research showed serious systemic events. Most localized adverse effects were mild or moderate and were resolved after treatment cessation. One study saw a higher percentage in the first 91 days of sofpironium treatment while 2 studies saw a higher incidence at the application site, compared to the vehicle group. Only 20 patients discontinued treatment due to these. Overall, the adverse effect profile is not as broad when compared to other hyperhidrosis treatments like aluminum chloride and glycopyrronium tosylate.

“Sofpironium’s low side-effect profile may encourage patient compliance and better control of hyperhidrosis. Consequently, its positive impact on qualitative life is appreciated,” the authors wrote. “In addition, systematic treatments have higher systemic effects than local ones and may have poor control over disease due to withdrawal and noncompliance of patients toward that drug.”

As for limitations, most of the studies were conducted in Japan and only one was held in the United States. These geographic factors and lack of diversity may affect the relevance and generalizability of findings. The follow-up duration was also varied, which could affect the analysis. More large-scale, high-quality studies with varying doses and populations are recommended to confirm these safety and efficacy results.

Hyperhidrosis is a relatively common disease, affecting 4.8% of the US population.² Sofpironium was approved by the FDA back in June as the first and only chemical entity for primary axillary hyperhidrosis, but this is the first published systemic review on its safety and effectiveness.

References

1. Odat RM, Yousef Aldalati A, Hammadeh BM, et al. Efficacy and safety of sofpironium in treatment of primary hyperhidrosis: a systematic review. J Dermatolog Treat. 2025;36(1):2441258. doi:10.1080/09546634.2024.2441258

2. Doolittle J, Walker P, Mills T, Thurston J. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res. 2016;308(10):743-749. doi:10.1007/s00403-016-1697-9