Topical oxybutynin antiperspirant for axillary hyperhidrosis: a phase IIb PROBE design clinical trial (TODAY trial)

J Vasc Bras. 2026 Sep 14;25:e20250065. doi: 10.1590/1677-5449.20250065. eCollection 2026.

ABSTRACT

BACKGROUND: Primary hyperhidrosis is a chronic condition with limited therapeutic options.

OBJECTIVES: To evaluate the impact of 10% oxybutynin spray on axillary hyperhidrosis, considering both its local and systemic effects, in terms of Hyperhidrosis Disease Severity Scale (HDSS) outcomes for hyperhidrosis of the axilla and eight additional sites.

METHODS: Prospective phase II PROBE design trial. Adult patients with axillary hyperhidrosis were randomized to receive a 10% oxybutynin topical spray, oral oxybutynin, or placebo spray for 35 days. Efficacy was evaluated on day 35 using the HDSS and a hyperhidrosis-specific quality-of-life (QoL) assessment questionnaire.

RESULTS: 17 patients were randomized. No significant differences were observed in HDSS outcomes from baseline to day 35 in any of the three groups (2.5 [2 – 4], 4 [3 – 4], 3.5 [3 – 4], p= 0.207), although a trend to improvement was noted in both treatment groups. Significant improvement in the QoL questionnaire was observed from baseline to day 35 in the oxybutynin spray group (pre-intervention QoL: 78.5 [70 – 96] and post-intervention QoL: 38.5 [32 – 67], p = 0.031).

CONCLUSIONS: No differences were observed in the primary outcome. A significant improvement from baseline to day 35 was observed in the QoL questionnaire score for the oxybutynin spray group.

PMID:42890128 | PMC:PMC13671017 | DOI:10.1590/1677-5449.20250065

Robotic selective thoracic sympathectomy for hyperhidrosis: refined technique and anatomical variation

Multimed Man Cardiothorac Surg. 2026 Oct 14;2026. doi: 10.1510/mmcts.2026.094.

ABSTRACT

Primary hyperhidrosis substantially impairs quality of life. Conventional sympathectomy risks compensatory hyperhidrosis through trunk disruption, whilst selective sympathectomy preserves the trunk while dividing preganglionic and postganglionic fibres. We describe a technique refinement and a previously undescribed anatomical variant. A 23-year-old man had severe refractory palmar, axillary, plantar and gustatory hyperhidrosis (SSDS 4) profoundly affecting his confidence, social functioning and mental wellbeing, despite conservative management. He underwent staged bilateral robotic selective dorsal thoracic sympathectomy. Preganglionic and postganglionic fibres were divided from the top of T2 to T4 with trunk preservation. Refinements included resection from the top of the second rib, minimal diathermy with sharp dissection and non-touch technique using Maryland bipolar forceps. On the right, a postganglionic ramus ascending retrogradely from a displaced T3 ganglion into the third intercostal space was identified, previously undescribed in the literature, requiring dissection across the fourth rib to prevent hypothesized residual axillary hyperhidrosis. Both stages were completed 1 month apart, drain-free, with next-day discharge. There was complete symptom resolution, no Horner’s syndrome and no compensatory hyperhidrosis at follow-up.

PMID:42872462 | DOI:10.1510/mmcts.2026.094

A 1% glycopyrronium bromide cream for topical treatment of severe primary axillary hyperhidrosis in adolescents: safety, local tolerability, systemic exposure and efficacy from an open-label phase II study

J Dtsch Dermatol Ges. 2026 Sep 15. doi: 10.1111/ddg.70469. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Primary axillary hyperhidrosis (PAHH) results from dysregulation of the autonomic nervous system and typically begins during puberty. Treatment options for adolescents remain limited. This open-label phase II study evaluated the safety, local tolerability, systemic exposure, and efficacy of 1% GPB cream over 8 weeks in adolescents with severe PAHH.

PATIENTS AND METHODS: A total of 42 adolescents (23 male [55%] and 19 female [45%]; aged 12-17 years) applied the cream once daily for the first 4 weeks and thereafter as needed (at least twice weekly but no more than once daily). The primary endpoints assessed adverse drug reactions (ADRs), local tolerability, and systemic glycopyrronium exposure. Changes in sweat production, PAHH severity, and quality of life were assessed in all patients.

RESULTS: Two patients experienced mild ADRs (dry eye and increased conjugated bilirubin in one patient each); no serious adverse events occurred. All 40 evaluable patients had a skin reaction score of 0 throughout treatment. Total sweat production decreased significantly from baseline to day 29 (p < 0.001) and day 57 (p < 0.001). Patient-rated hyperhidrosis severity (PRHS) and quality of life, assessed using the Children’s Dermatology Life Quality Index (CDLQI), also improved significantly at both time points (all p < 0.001).

CONCLUSIONS: 1% GPB cream showed favorable safety and tolerability and improved clinical outcomes in adolescents with severe PAHH, consistent with findings in adults.

PMID:42745527 | DOI:10.1111/ddg.70469

Botulinum toxin A for primary axillary hyperhidrosis: a narrative review

J Med Life. 2026 Jun;19(6):420-425. doi: 10.25122/jml-2026-0005.

ABSTRACT

Primary axillary hyperhidrosis (PAH) markedly impairs psychosocial well-being and daily functioning. Botulinum toxin type A (BoNT-A) is widely used, both on- and off-label, to suppress eccrine sweating through presynaptic inhibition of acetylcholine release and temporary chemodenervation of cholinergic sympathetic fibers. This narrative review synthesizes published clinical evidence between 2000 and January 2025 regarding the efficacy, durability, safety, and quality-of-life outcomes of BoNT-A for PAH, with comparative consideration of toxin formulations, injection techniques, and device-based alternatives. Evidence from randomized trials, prospective cohorts, long-term observational studies, and meta-analyses consistently demonstrates that intradermal BoNT-A achieves substantial axillary sweat reduction, often exceeding 50-80%, with improvement of at least two grades on the Hyperhidrosis Disease Severity Scale and meaningful reductions in Dermatology Life Quality Index scores. Treatment effects typically persist for approximately 4-7 months per cycle and are associated with predominantly mild, localized adverse events. Comparative data indicate similar efficacy among onabotulinumtoxinA, incobotulinumtoxinA, and abobotulinumtoxinA when equivalent dosing and standardized mapping techniques are applied. Injection strategy, particularly multi-point intradermal delivery guided by starch-iodine mapping, influences coverage and durability. Energy-based modalities-including microwave thermolysis and fractional microneedle radiofrequency-reduce sweating via device-mediated thermal targeting of eccrine glands and show variable comparative outcomes versus intradermal BoNT-A in durability, downtime, and cost. Overall, BoNT-A remains a well-supported first-line injectable therapy for PAH refractory to topical treatment, while further head-to-head and cost-effectiveness studies remain warranted.

PMID:42602382 | PMC:PMC13474375 | DOI:10.25122/jml-2026-0005

Real-World Outcomes of Microwave Treatment for Axillary Hyperhidrosis and Bromhidrosis: A 12-Month Study in a Southeast Asian Setting

Clin Cosmet Investig Dermatol. 2026 Jul 25;19:617844. doi: 10.2147/CCID.S617844. eCollection 2026.

ABSTRACT

BACKGROUND: Microwave therapy has emerged as a minimally invasive treatment option, but long-term real-world data, particularly from Southeast Asian populations, remain limited.

PURPOSE: To evaluate the effectiveness of microwave therapy and its impact on quality of life (QoL) in patients with axillary hyperhidrosis and bromhidrosis.

PATIENTS AND METHODS: A longitudinal ambispective case series study was conducted on 52 adult patients with axillary hyperhidrosis and bromhidrosis treated with microwave therapy. Treatment efficacy and QoL improvement were assessed at 1 week and at 3, 6, 9, and 12 months post-intervention using the Minor test, Hyperhidrosis Disease Severity Scale (HDSS), Visual Analog Scale (VAS), and Dermatology Life Quality Index (DLQI). Repeated measures were analyzed using mixed-effects models.

RESULTS: At 1 week, the mean area of discoloration decreased markedly from 49.1 cm2 to 0.3 cm2 in the left axilla, with similar improvement observed in the right axilla. At 12 months, compared with baseline, the model-predicted probability of HDSS grade 4 decreased from 68.2% to 5.7%, while the mean odor score and DLQI score decreased from 6.8 to 3.0 and from 19.5 to 6.5, respectively. Overall satisfaction at 12 months was 66.6%. Statistically significant improvements were observed across the majority of efficacy outcomes (p < 0.05). The most common adverse events were pain and swelling, which were mild and self-limiting, with no serious complications reported.

CONCLUSION: Microwave therapy demonstrated a favorable safety profile and sustained clinical benefits in patients with axillary hyperhidrosis and bromhidrosis over 12 months of follow-up. Although patient satisfaction declined modestly at 12 months, overall treatment outcomes remained favorable.

PMID:42529744 | PMC:PMC13418893 | DOI:10.2147/CCID.S617844

Clinical Characteristics and Treatment Patterns of Hyperhidrosis in Northern Hokkaido: A Single-Center Retrospective Descriptive Study

J Dermatol. 2026 Jul 1. doi: 10.1111/1346-8138.70373. Online ahead of print.

ABSTRACT

Hyperhidrosis is a common condition associated with a substantial negative impact on the quality of life. Several studies have described the clinical characteristics and disease burden of patients with hyperhidrosis in Japan. However, comparable real-world clinical data on hyperhidrosis from Hokkaido remain limited. We therefore evaluated real-world clinical practice patterns at our institution before and after the establishment of a specialized outpatient clinic for hyperhidrosis. In this retrospective study, we analyzed the data of 144 patients who presented with hyperhidrosis between November 2013 and March 2025. Patient characteristics, pathways to care, treatment modalities, and treatment continuation were evaluated using data from electronic medical records. The sex distribution, age at presentation, and subtype distribution of hyperhidrosis in our cohort were largely consistent with those reported in a prior nationwide survey. Primary axillary and/or palmar hyperhidrosis accounted for 87.5% of all cases. After launching a specialized clinic in April 2023, we observed a substantial increase in the number of patients who consulted for hyperhidrosis during visits for other dermatologic conditions; this finding may suggest the presence of previously unrecognized patients. However, changes in hospital access policies may also have influenced consultation patterns. The treatment continuation rates for axillary and palmar hyperhidrosis were both approximately 40%. Among the treatments for axillary hyperhidrosis, sofpironium bromide gel was prescribed most frequently, whereas glycopyrronium tosylate hydrate wipes showed a higher treatment continuation rate. In conclusion, the presence of a specialized outpatient clinic may improve access to care for patients with primary focal hyperhidrosis and facilitate the identification of previously unrecognized patients. However, treatment continuation remained suboptimal, highlighting the importance of improving continuity of care in hyperhidrosis management at our institution.

PMID:42385158 | DOI:10.1111/1346-8138.70373

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

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