Category: Topical

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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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Advances in pharmacological treatment and management of hyperhidrosis

Expert Opin Pharmacother. 2026 Mar 23:1-10. doi: 10.1080/14656566.2026.2642213. Online ahead of print.

ABSTRACT

INTRODUCTION: Hyperhidrosis is a functional disorder characterized by excessive sweat production beyond physiological needs for thermoregulation, significantly impairing quality of life, affecting physical comfort, psychological well-being, social interactions, and work productivity.

AREAS COVERED: This review focuses on evidence-based therapeutic options for hyperhidrosis. Topical treatments (glycopyrronium bromide, glycopyrronium tosylate, aluminum salts), systemic therapy (oral oxybutynin), injectable approaches (botulinum toxin), iontophoresis, and surgical interventions (local excision, sympathectomy) are discussed in detail. Clinical studies demonstrate that topical and systemic agents are effective for localized and multisite forms, respectively, while botulinum toxin offers strong efficacy for focal hyperhidrosis. The review also addresses combination strategies, treatment tolerability, cost-effectiveness, and patient-centered approaches.

EXPERT OPINION: Managing hyperhidrosis requires a nuanced, individualized strategy that balances symptom control, safety, patient preferences, and quality of life. Combination therapies and flexible treatment sequencing can reduce early reliance on invasive procedures. Despite therapeutic advances, widespread adoption is limited by heterogeneous guidelines, off-label use, and under-recognition of psychosocial impact. Future research should focus on prospective, large-cohort studies, standardized outcome measures, and development of selective, well-tolerated therapies. While a universal cure is unlikely, sustained symptom control and meaningful improvement in quality of life represent realistic objectives.

PMID:41871366 | DOI:10.1080/14656566.2026.2642213

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A significant gap between inadequate pharmacotherapy and substantial unmet needs in palmar hyperhidrosis management in China: insights from a questionnaire-based survey among outpatients

Front Pharmacol. 2026 Jan 8;16:1715189. doi: 10.3389/fphar.2025.1715189. eCollection 2025.

ABSTRACT

BACKGROUND: Palmar hyperhidrosis, characterized by excessive sweating primarily affecting the hands, significantly impairs quality of life and psychological well-being. Although topical agents, iontophoresis, microwave therapy, and sympathectomy are established interventions, real-world treatment patterns and pharmacotherapeutic adequacy among Chinese patients remain poorly delineated.

METHODS: An anonymous, questionnaire-based survey was conducted among consecutive patients at a tertiary thoracic surgery clinic in China between March 2023 and October 2024. A total of 363 valid responses were collected and analyzed using SPSS 27.0. Descriptive statistics and multivariable logistic regression were used to evaluate treatment patterns, patient preference, and predictors of treatment selection.

RESULTS: The study cohort was composed predominantly of individuals with severe disease (87.3% HDSS grade 3-4), and nearly all participants (97.8%) presented with palmar hyperhidrosis. Regarding treatment history, only 38.1% had previously received pharmacotherapy, while 32.6% had utilized Traditional Chinese Medicine (TCM) therapeutic approaches, including TCM, acupuncture, massage and manipulation therapies. Antiperspirants (28.6%) and TCM (25.0%) were the most frequently used prior pharmacotherapies, yet both were associated with limited therapeutic efficacy. According to our survey, owing to high symptom severity, 52.9% had a general knowledge of surgical intervention before the outpatient visit. Primary concerns regarding previous pharmacotherapy included insufficient efficacy and localized adverse effects, particularly skin irritation. Notably, 50.0% of participants remained receptive to future pharmacotherapy, showing a preference for topical formulations (29.3%) and reduced dosing frequency (31.6%). Gender and disease severity were identified as significant determinants of treatment choice. Importantly, prior negative experiences – such as inefficacy and side effects – did not significantly diminish willingness to consider future pharmacologic treatment.

CONCLUSION: Inadequate management and suboptimal treatment outcomes represent considerable challenges in the care of palmar hyperhidrosis in China. Existing pharmacotherapeutic options are constrained by limited availability, inadequate efficacy, and a narrow range of approved agents – a reality that highlights a critical disconnect with substantial patient demand. These findings underscore an urgent need to accelerate drug development and clinical translation in this field.

PMID:41585901 | PMC:PMC12823788 | DOI:10.3389/fphar.2025.1715189

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Hyperhidrosis: Diagnosis and management strategies

Nurse Pract. 2025 Oct 1;50(10):31-36. doi: 10.1097/01.NPR.0000000000000354. Epub 2025 Sep 25.

ABSTRACT

Hyperhidrosis, a condition characterized by an overactive cooling system that produces four to five times the normal amount of sweat, can profoundly impact a person’s physical, psychological, and social well-being. It can be classified as primary or secondary, and the location and severity determine treatment options. These options include topical agents, systemic agents, and nonsurgical and surgical procedures. Nurse practitioners play a crucial role in managing this condition, and their awareness and understanding are vital in designing effective treatment options for their patients. This article aims to enhance knowledge by discussing hyperhidrosis, its impact on a patient’s physical and psychological well-being, and recommended treatment modalities.

PMID:40996843 | DOI:10.1097/01.NPR.0000000000000354

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Efficacy and Safety of Treatments for Primary Palmar Hyperhidrosis: A Systematic Review Assessing Patient-Centric Outcomes

Dermatol Res Pract. 2025 Aug 20;2025:8867838. doi: 10.1155/drp/8867838. eCollection 2025.

ABSTRACT

Background: Primary palmar hyperhidrosis (PH) is a chronic condition characterized by excessive sweating in the palms, significantly affecting the quality of life (QOL) of affected individuals. Despite the availability of various treatment modalities, the long-term efficacy and safety of these interventions remain unclear, warranting a comprehensive evaluation. This systematic review aims to assess the efficacy, safety and patient-reported outcomes of treatments for PH. Methods: A systematic search was conducted in PubMed, Embase and the Cochrane Library from their inception until March 2024, adhering to PRISMA guidelines. Inclusion criteria focused on prospective and retrospective studies examining PH treatments published in English. Data from eligible studies were extracted, analysed qualitatively and reported based on outcomes, including efficacy, QOL improvements and adverse effects. Results: Fourteen studies, including 1733 patients aged 4-77 years, were included in the final review. The treatments assessed included oral and topical oxybutynin, iontophoresis, botulinum toxin A injections, photodynamic therapy (PDT) and endoscopic thoracic sympathectomy (ETS). Oral oxybutynin demonstrated symptomatic relief in 60%-97% of the patients although anticholinergic side effects were frequently reported. ETS, while providing the highest rates of complete sweat cessation, was associated with compensatory hyperhidrosis. Noninvasive treatments like iontophoresis showed moderate efficacy with minimal side effects but required ongoing sessions for maintenance. Conclusion: This review highlights the efficacy of several therapeutic approaches for PH though most treatments are hindered by significant adverse effects or practical limitations. Future research should prioritize long-term studies and standardized outcome measures to guide clinical decision-making more effectively.

PMID:40881604 | PMC:PMC12390518 | DOI:10.1155/drp/8867838

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Primary hyperhidrosis: an updated review

Drugs Context. 2025 Jun 16;14:2025-3-2. doi: 10.7573/dic.2025-3-2. eCollection 2025.

ABSTRACT

BACKGROUND: Hyperhidrosis (HH) is a condition characterized by excessive sweating beyond the physiological needs of thermoregulation. HH can be classified as primary (idiopathic) hyperhidrosis (PHH) or secondary hyperhidrosis (SHH), which is associated with underlying medical conditions, medications or systemic disorders. This narrative review provides an updated overview of PHH, with a focus on epidemiology, aetiopathogenesis, clinical manifestations, diagnostic approaches and current management strategies, particularly highlighting pharmacological and procedural treatment options.

METHODS: A literature search was conducted in February 2025 across Ovid Medline, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) using the key term “hyperhidrosis”. The review included observational studies, clinical trials, narrative reviews, guidelines and meta-analyses published in the past 10 years. Additional references were identified through manual searches of relevant bibliographies.

RESULTS: The global prevalence of PHH is estimated to range between 0.072% and 9%, with PHH accounting for 93% of all HH cases. Whilst the precise pathophysiology remains unclear, PHH is believed to result from sympathetic overactivity, whereas SHH is associated with endocrine, neurological, infectious, malignant and medication-induced causes. PHH is diagnosed clinically and distinguishing between primary and secondary forms is essential. Management options vary based on severity, ranging from topical therapies (antiperspirants, anticholinergics), systemic medications (oral anticholinergics, adrenergic modulators), device-based interventions (iontophoresis, microwave thermolysis), injectable therapies (botulinum toxin) and surgical approaches (sympathectomy, excision, liposuction/curettage). Whilst these interventions can significantly improve symptoms and quality of life, long-term efficacy, recurrence and adverse effects remain concerns.

CONCLUSION: PHH significantly impacts the quality life of patients contributing to both physical discomfort and psychosocial distress. An individualized, multi-modal approach is crucial to optimizing management. Further research is warranted to refine existing therapies and evaluate emerging treatment modalities for improved long-term outcomes.

PMID:40575073 | PMC:PMC12201942 | DOI:10.7573/dic.2025-3-2

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Primary Hyperhidrosis in Children: Current Perspectives and Therapeutic Options

Pediatr Ann. 2025 Jun;54(6):e196-e202. doi: 10.3928/19382359-20250321-03. Epub 2025 Jun 1.

ABSTRACT

Primary hyperhidrosis is a common condition that often begins before age 18 years and frequently presents to the pediatric primary care provider. It can have significant negative impacts on a child’s quality of life (QOL) and emotional well-being. There are a variety of treatment options available that have been shown to decrease symptoms, as well as improve QOL. These treatments include over-the-counter antiperspirants, prescription antiperspirants, topical anticholinergics, iontophoresis, systemic anticholinergics, injectable botulinum toxin, and surgical sympathectomy. Treatment of this condition is lifelong and often nuanced. It is imperative for the pediatric practitioner to be well versed in the risks and benefits, as well as proper usage, of these various therapeutic modalities. With this knowledge, effective treatment plans can be crafted to improve both the physical and mental health of affected children. [Pediatr Ann. 2025;54(6):e196-e202.].

PMID:40489364 | DOI:10.3928/19382359-20250321-03