Category: Axillary

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Efficacy and safety of topical sofpironium bromide in treating primary axillary hyperhidrosis: systematic review and meta-analysis of randomized controlled trials

Dermatol Reports. 2026 Jun 16. doi: 10.4081/dr.2026.10853. Online ahead of print.

ABSTRACT

This systematic review and meta-analysis aimed to comprehensively evaluate the efficacy and safety of topical sofpironium bromide in patients with primary axillary hyperhidrosis (PAH) in various published randomized controlled trials (RCTs). The study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We systematically searched PubMed, Scopus, Web of Science, Embase, and Medline databases through April 30, 2025, using keywords related to sofpironium and PAH. The odds ratio (OR) or mean difference (MD) was calculated using a random effects model with 95% confidence interval (CI). Three RCTs of sofpironium were included in the meta-analysis, with 1,209 patients with PAH. Sofpironium, compared to the vehicle, showed statistically significant improvement in the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) score (OR=2.35, 95% CI [1.82 to 3.04]), Hyperhidrosis Disease Severity Scale (HDSS) score (OR=2.02, [1.46 to 2.79]), Dermatology Life Quality Index (DLQI) score (MD=-2.75, [-3.58 to -1.92]), and gravimetric sweat production (MD=-26.39, [-44.65 to -8.12]). The incidences of anticholinergic adverse events (AEs) and application site AEs were statistically higher in patients treated with sofpironium. Sofpironium is an effective treatment for PAH associated with significant improvements in sweat reduction and QOL for patients, although the drug also has risks of anticholinergic or application-site AEs.

PMID:42299704 | DOI:10.4081/dr.2026.10853

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Sofpironium Bromide for the Treatment of Primary Axillary Hyperhidrosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Cureus. 2026 May 9;18(5):e108570. doi: 10.7759/cureus.108570. eCollection 2026 May.

ABSTRACT

Sofpironium bromide is a recently approved topical anticholinergic agent for primary axillary hyperhidrosis, developed using a retrometabolic approach to limit systemic side effects. However, randomized evidence about its effects has not yet been quantitatively synthesized. This meta-analysis aimed to assess the efficacy and safety of topical sofpironium bromide compared with a vehicle in patients with primary axillary hyperhidrosis. PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov were searched for randomized controlled trials (RCTs) comparing topical sofpironium bromide with a vehicle. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were pooled using random-effects models in Review Manager 7.2.0 (The Cochrane Collaboration, London, UK). Five RCTs, including 1,398 participants, were included, of whom 807 (57.7%) received topical sofpironium bromide. Compared with vehicle, sofpironium bromide significantly reduced gravimetric sweat production (GSP) at the end of treatment (MD -25.27 mg; 95% CI -40.15 to -10.40) and increased the likelihood of achieving at least a two-point improvement in the Hyperhidrosis Disease Severity Scale (HDSS) (RR 3.27; 95% CI 1.57-6.80). Discontinuation due to adverse events was more frequent in the sofpironium bromide group (RR 9.83; 95% CI 1.82-53.17). Adverse events occurred more frequently in the treatment group, including application-site dermatitis (RR 5.26; 95% CI 2.05-13.48), application-site pain (RR 4.63; 95% CI 2.08-10.28), pruritus (RR 5.97; 95% CI 1.98-18.02), and dry mouth (RR 15.45; 95% CI 5.35-44.62). No significant increase in serious adverse events was observed. Overall, this meta-analysis supports the efficacy of sofpironium bromide for primary axillary hyperhidrosis, while treatment decisions should be weighed against potential side effects.

PMID:42272574 | PMC:PMC13246317 | DOI:10.7759/cureus.108570

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Efficacy and Safety of Topical Anticholinergics in the Treatment of Primary Axillary Hyperhidrosis: A Systematic Review and Meta-analysis

Clin Drug Investig. 2026 Apr 16. doi: 10.1007/s40261-026-01550-2. Online ahead of print.

ABSTRACT

BACKGROUND: Topical anticholinergic agents are non-invasive treatment options for primary axillary hyperhidrosis (PAH). Sofpironium bromide was recently approved by the US Food and Drug Administration (FDA). A comprehensive evaluation of the efficacy and safety of available topical anticholinergics may inform clinical practice.

OBJECTIVES: To assess the efficacy and safety of topical anticholinergic therapies for PAH through systematic review and meta-analysis of randomized controlled trials (RCTs).

METHODS: Five databases were searched on September 9, 2024. Primary outcomes included a ≥2-point improvement in the Hyperhidrosis Disease Severity Scale (HDSS) and ≥50% reduction in gravimetric sweat production (GSP). Secondary outcomes included subjective symptom improvement and objective sweat reduction. Safety outcomes included treatment-emergent adverse events (TEAEs), anticholinergic-related adverse events, and local application site reactions. The review protocol was registered in PROSPERO (CRD42024583376).

RESULTS: Eight RCTs (n = 1921) that evaluated glycopyrronium, sofpironium bromide, and umeclidinium were included. Topical agents significantly outperformed placebos for HDSS ≥2-point improvement (risk ratio [RR]: 2.40; 95% confidence interval [CI]: 2.01-2.86) and GSP ≥50% reduction (RR: 1.43; 95% CI: 1.21-1.70). Sofpironium was the most effective HDSS treatment, whereas glycopyrronium showed highest efficacy against GSP. Topical agents were associated with increased risk of TEAEs (RR: 1.43; 95% CI: 1.14-1.79), with sofpironium associated with highest risk of dry mouth and glycopyrronium with highest risks for mydriasis and constipation.

CONCLUSIONS: Topical anticholinergic agents are effective for PAH treatment, with distinct efficacy and safety profiles. Although the available evidence is limited by the small number of trials, short follow-up durations, and heterogeneity in outcome reporting, these findings support the role of topical anticholinergic therapy as an effective non-invasive option for PAH.

PMID:41989535 | DOI:10.1007/s40261-026-01550-2

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Robotic ramicotomy for palmar and axillary hyperhidrosis

Multimed Man Cardiothorac Surg. 2026 Mar 4;2026. doi: 10.1510/mmcts.2025.150.

ABSTRACT

Ramicotomy is a surgical approach that focuses on dividing the rami communicantes of the sympathetic chain and has been introduced as a treatment for palmar and axillary hyperhidrosis with the goal of reducing the incidence of compensatory sweating. Evidence from recent randomized controlled studies and meta-analyses suggests that this technique effectively reduces localized excessive sweating while resulting in lower rates of compensatory hyperhidrosis and less postoperative hand dryness compared with traditional sympathetic chain interruption. Despite these advantages, ramicotomy has been linked to a greater likelihood of symptom recurrence, underscoring the importance of thorough patient selection and detailed preoperative counseling about potential long-term outcomes. Overall quality of life improvements and patient satisfaction appear similar between ramicotomy and conventional sympathicotomy, although ramicotomy may provide benefits in decreasing the severity or extent of compensatory sweating. In cases of axillary hyperhidrosis, combining ramicotomy with endoscopic sympathetic blockade does not seem to significantly change patient satisfaction or overall rates of compensatory sweating compared with blockade alone, though it may influence the pattern or distribution of compensatory symptoms. In summary, ramicotomy is a reasonable surgical option for carefully selected patients who prioritize a lower risk of compensatory hyperhidrosis, accepting the trade-off of a potentially higher recurrence rate.

PMID:41778845 | DOI:10.1510/mmcts.2025.150

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A multi-center, cross-sectional questionnaire survey in Japan (KOBE study) exploring factors associated with primary focal hyperhidrosis

Front Med (Lausanne). 2026 Feb 9;13:1739715. doi: 10.3389/fmed.2026.1739715. eCollection 2026.

ABSTRACT

BACKGROUND/AIM: Primary focal hyperhidrosis (PFH) is defined as a condition characterized by excessive sweating in localized areas, which causes patients to experience difficulties in daily life, regardless of temperature or psychological stress. Previous surveys in Japan have revealed that the majority of patients with PFH may not visit medical institutions. Identifying the factors potentially associated with PFH is useful for detecting unmedicated patients and providing appropriate medical interventions. In this study, we explored factors associated with PFH in a multi-center, cross-sectional questionnaire survey (KOBE study).

METHODS: This study enrolled patients aged 5-64 years who visited 1 of the 24 dermatological institutions in Japan between April and July 2024 and completed a questionnaire (registered at the Japan Registry of Clinical Trials: jRCT1050250083). A combination of univariate and multivariate logistic regression analyses was performed to explore the associated factors.

RESULTS: A total of 3,617 participants were included in the analysis. The prevalence of PFH was 15.0% (544 of 3,617 participants). Among the potential associated factors, the odds ratios (ORs) were higher in order of axillary osmidrosis (OR = 5.440), psoriasis (OR = 1.830), wet earwax (OR = 1.780), a definite Hospital Anxiety and Depression Scale-Anxiety (HADS-A) score (OR = 1.780), a doubtful HADS-A score (OR = 1.460), and smoking (OR = 1.450). Receiver operating characteristic (ROC) curve analysis indicated that a HADS-A score of 6 was the optimal cutoff value for suspecting PFH.

CONCLUSION: These findings may aid in detecting unmedicated potential patients in routine clinical practice and promoting active intervention for the disease, ultimately improving the quality of life and well-being of patients with PFH.

PMID:41737399 | PMC:PMC12927475 | DOI:10.3389/fmed.2026.1739715

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Early onset, genital, and axillary involvement are strongly associated with impaired quality of life in hyperhidrosis patients

Medicine (Baltimore). 2026 Feb 20;105(8):e47698. doi: 10.1097/MD.0000000000047698.

ABSTRACT

Hyperhidrosis is a chronic condition marked by excessive sweating that significantly affects patients’ quality of life (QoL). However, this issue is both underrecognized and undertreated, and its physical, emotional, and social burdens are often underestimated, particularly in Middle Eastern populations. A cross-sectional, analytical study was conducted across Saudi Arabia between May 2024 and April 2025. Participants were recruited through dermatology clinics and a Telegram support group. They completed an online self-administered Arabic questionnaire regarding demographics, medical history, the Arabic Hyperhidrosis Disease Severity Scale, and the Hyperhidrosis Quality of Life Index. A total of 276 Arabic-speaking adults with hyperhidrosis participated. The mean age was 27.3 years (SD ± 8.2), and 57.6% of the respondents were male. Most participants (82.9%) had severe hyperhidrosis (Hyperhidrosis Disease Severity Scale grades 3-4). The mean HidroQoL scores were 10.3 out of 14 for daily life and 16.6 out of 22 for psychosocial life, indicating moderate to severe burden. Disease severity showed the strongest association with QoL impairment (P = .001). Other factors significantly associated with daily functioning included lower education level, lower income, and sweating in the axillae and genital region, while genital involvement and low education were associated with psychosocial distress. Hyperhidrosis imposed a substantial QoL burden, especially in patients with severe symptoms and lower socioeconomic status. The findings supported the need for early detection and tailored treatment strategies and the use of culturally validated patient-reported outcome measures like the Arabic HidroQoL in clinical practice.

PMID:41731822 | DOI:10.1097/MD.0000000000047698

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Hyperhidrosis: Prevalence, Diagnosis, and Stepwise Treatment

Dtsch Arztebl Int. 2026 May 1;(Forthcoming):arztebl.m2025.0229. doi: 10.3238/arztebl.m2025.0229. Online ahead of print.

ABSTRACT

BACKGROUND: Hyperhidrosis, or sweating beyond the physiological amount, can be either focal or generalized and sometimes runs in families. The prevalence of primary idiopathic hyperhidrosis is 2-5%. Secondary hyperhidrosis is associated with specific illnesses and medications. In this article, we discuss the diagnostic evaluation of hyperhidrosis and treatments for it, along with their efficacy and side effects.

METHODS: This narrative review is based on publications retrieved from the Medline and Cochrane databases with the search term “hyperhidrosis” and other specific terms relating to treatment. Expert recommendations and guidelines were considered as well.

RESULTS: The diagnostic evaluation consists of a clinical history, a Minor (starch-iodine) test, gravimetry, and dynamic sudometry. There have been no more than a few high-quality published studies on specific interventions. Depending on the severity and symptom burden, aluminum chloride and anticholinergic drugs are used first, followed by botulinum toxin injections and subcutaneous curettage for axillary hyperhidrosis. These treatments reportedly bring about marked improvement in 60-70 % of patients; their side effects, depending on the particular treatment used, include local reactions such as itch, pain, and cutaneous irritation and anticholinergic effects such as dry mouth, mydriasis, urinary retention, and headache. Further therapeutic options are tap water iontophoresis; radiofrequency, focused ultrasound, and microwave treatment; systemically administered anticholinergic drugs; and thoracic or lumbar sympathectomy for palmar or plantar hyperhidrosis, respectively.

CONCLUSION: A variety of methods can be used to relieve hyperhidrosis and improve these patients’ quality of life. There have been no more than a few high-quality studies on their efficacy and long-term results.

PMID:41572865 | DOI:10.3238/arztebl.m2025.0229