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Sofpironium topical gel, 12.45%, for the treatment of axillary hyperhidrosis: pooled efficacy and safety results from 2 phase 3 randomized, controlled, double-blind studies

J Am Acad Dermatol. 2025 Mar 5:S0190-9622(25)00393-7. doi: 10.1016/j.jaad.2025.02.086. Online ahead of print.

ABSTRACT

BACKGROUND: Current treatments for primary axillary hyperhidrosis are insufficient for some patients. Sofpironium topical gel is a retrometabolically-designed topical anticholinergic with rapid metabolism, which is associated with reduced side effects and targeted efficacy.

OBJECTIVE: To assess efficacy and safety of sofpironium topical gel for primary axillary hyperhidrosis.

METHODS: Cardigan I and Cardigan II were double-blind, randomized, controlled pivotal phase 3 studies of sofpironium topical gel, 12.45%, versus vehicle gel (1:1 randomization) for daily application to the axillae for 6 weeks.

RESULTS: The combined Phase 3 studies included 353 subjects in the treatment groups and 348 subjects in the control groups. For the co-primary endpoint of ≥2-point improvement from baseline to end of treatment on Hyperhidrosis Disease Severity Measure-Axillary-7, pooled analyses showed significantly better results for treatment versus control (p<0.0001). For the pooled co-primary endpoint of gravimetric sweat production at treatment end, the treatment group had greater reduction in sweat production (p=0.0002). Secondary endpoints also showed a statistically significant benefit for sofpironium topical gel versus control. Treatment was well-tolerated.

LIMITATIONS: Short treatment and follow-up periods.

CONCLUSION: Sofpironium topical gel, 12.45%, applied topically once daily before bedtime is effective and well-tolerated for treatment of primary axillary hyperhidrosis in patients ≥9 years old.

PMID:40054501 | DOI:10.1016/j.jaad.2025.02.086

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Hyperhidrosis: don’t sweat it

Intern Med J. 2025 Mar 7. doi: 10.1111/imj.70019. Online ahead of print.

ABSTRACT

Hyperhidrosis is an under-reported and under-treated condition that causes significant patient morbidity. Secondary causes require consideration, but the vast majority of cases are idiopathic. The condition is encountered by a range of clinicians, including neurologists, dermatologists and endocrinologists, and it pays to be familiar with the range of highly effective treatment options available for the treatment of both focal and generalised sweating disorders. We outline the treatment options and therapeutic approach to the most common hyperhidrosis phenotypes, with illustrative cases.

PMID:40051370 | DOI:10.1111/imj.70019

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Hyperhidrosis, anticholinergics, and dementia

Actas Dermosifiliogr. 2025 Feb 28:S0001-7310(25)00110-3. doi: 10.1016/j.ad.2024.11.026. Online ahead of print.

ABSTRACT

In recent decades, the use of certain oral anticholinergics for the treatment of hyperhidrosis has become widespread, often off-label but supported by multiple studies, including clinical trials, demonstrating their effectiveness and an apparently good safety profile. Similarly, various studies published in recent years have associated the use of anticholinergics to the development of dementia, particularly in elderly patients. Additionally, other studies have suggested that hyperhidrosis itself may be an early symptom of developing dementia. However, to date, no research has specifically linked the use of oral anticholinergics for hyperhidrosis treatment with the development of dementia. We present the currently available data on this controversial topic.

PMID:40024600 | DOI:10.1016/j.ad.2024.11.026

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Topical oxybutynin deodorant for axillary hyperhidrosis: a topic or a systemic effect? Rationale and design of the phase II today trial

J Vasc Bras. 2025 Feb 21;24:e20240098. doi: 10.1590/1677-5449.202400982. eCollection 2025.

ABSTRACT

Anticholinergics have been shown to enhance quality of life and reduce sweat in patients with hyperhidrosis. However, it remains unclear whether topical application specifically exerts local or systemic effects. This study’s primary aim is to assess topical oxybutynin’s impact on axillary hyperhidrosis. Twenty patients will be randomized into three groups. Group A will receive 2.5 mg of oral oxybutynin from day 1 to day 35 (on a variable frequency regimen). Group B will be administered a topical placebo for 35 days and Group C will receive a 10% oxybutynin topical spray, to be used twice daily for 35 days. The primary efficacy outcome will be the evaluation of the effectiveness of topical oxybutynin spray in treating hyperhidrosis. The TODAY trial will generate high-quality evidence on the effects of topical oxybutynin, assessing whether its impact is local or systemic in patients with axillary hyperhidrosis.

PMID:40012967 | PMC:PMC11864779 | DOI:10.1590/1677-5449.202400982

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Arabic Translation, Cultural Adaptation, and Validation of the Hyperhidrosis Disease Severity Scale (Ar-HDSS)

Healthcare (Basel). 2025 Feb 12;13(4):397. doi: 10.3390/healthcare13040397.

ABSTRACT

Background: Hyperhidrosis (HH) is characterized by excessive sweating, which affects quality of life. The Hyperhidrosis Disease Severity Scale (HDSS) is a four-point scale used to evaluate HH severity by measuring how much excessive sweating disrupts daily activities. This study aimed to translate, validate, and adapt the HDSS tool into Arabic. Methods: A quantitative, analytical, cross-sectional study was carried out from May to June 2024 on patients clinically diagnosed with HH. The process of translating the HDSS into Arabic involved three independent forward translations, followed by a preliminary version created by a reviewer. Three additional independent translators conducted backward translations. All of the versions were then revised and merged to produce the final version. Reliability was evaluated through a test-retest reliability approach to ensure the reproducibility of the results. For validity, we used construct validity to compare the HDSS with the HidroQoL index. Results: A total of 167 patients were included, with a mean age of 29 ± 9.02 years, and over half of the patients were male (61%). The interrater agreement between the HDSS test and the retest results was substantial, with a kappa coefficient of 0.732. Significant positive correlations were observed between the HDSS score and daily life (r = 0.413, p < 0.001), the psychological domain (r = 0.374, p < 0.001), and HidroQOL (r = 0.425, p < 0.001). Conclusions: Our findings demonstrate that the Arabic HDSS has excellent psychometric properties, including construct validity and reproducibility. Proper use of the Arabic HDSS will allow the effective assessment of HH severity.

PMID:39997272 | DOI:10.3390/healthcare13040397

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Switching to levomethadone improves methadone-induced hyperhidrosis: A case report

J Addict Dis. 2025 Feb 5:1-5. doi: 10.1080/10550887.2024.2443696. Online ahead of print.

ABSTRACT

Methadone maintenance therapy is the cornerstone of treatment for heroin addiction. Hyperhidrosis is a common and often-overlooked side effect of methadone. Different medications, such as antihistamines and anticholinergic drugs, have been reported to be effective against opioid-induced sweating, but there is no standardized therapy. A 51-year-old patient under methadone maintenance therapy reported long-standing hyperhidrosis, which worsened each time the methadone dosage was increased. After substituting methadone with levomethadone, while maintaining equivalent dosages, the patient reported a stark reduction in sweating. Therefore, levomethadone could be a promising alternative for patients in methadone maintenance therapy who suffer from methadone-induced hyperhidrosis.

PMID:39910803 | DOI:10.1080/10550887.2024.2443696

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Comparison of the effectiveness and safety between ramicotomy and sympathetic chain interruption in the treatment of primary hyperhidrosis: a meta-analysis

Clin Auton Res. 2025 Feb 5. doi: 10.1007/s10286-025-01115-x. Online ahead of print.

ABSTRACT

OBJECTIVE: This meta-analysis evaluates the effectiveness and safety of ramicotomy versus sympathetic chain interruption (SCI) in treating primary hyperhidrosis (PH).

METHODS: A comprehensive literature search was conducted across multiple databases, including PubMed, Embase, Web of Science, Ovid, Cochrane Library, CNKI, and Wanfang, covering studies from their inception through October 2024. A total of 10 studies involving 970 patients were included, with 504 patients undergoing ramicotomy and 466 receiving SCI.

RESULTS: The analysis revealed that patients undergoing ramicotomy experienced significantly lower rates of compensatory hyperhidrosis (CH) [odds ratio (OR) 0.41, 95% confidence interval (CI) 0.20-0.85, P = 0.02], severe CH (OR 0.17, 95% CI 0.06, 0.47, P < 0.001), and postoperative hand dryness (OR 0.10, 95% CI 0.01-0.72, P = 0.02), along with a higher recurrence rate (OR 4.03, 95% CI 2.38, 6.85, P < 0.001). No significant differences were observed in operative duration [mean difference (MD) = 0.19, 95% CI -18.23, 18.60, P = 0.98 > 0.05], length of hospital stay (MD = -0.08, 95% CI -0.19, 0.04, P = 0.20 > 0.05), total postoperative complications (OR 0.41, 95% CI 0.07, 2.34, P = 0.32 > 0.05), or surgical satisfaction (OR 0.93, 95% CI 0.45, 1.91, P = 0.83 > 0.05).

CONCLUSIONS: While ramicotomy results in lower incidences of CH and postoperative hand dryness, its higher recurrence rate suggests that its application should be cautious to manage PH effectively.

PMID:39907932 | DOI:10.1007/s10286-025-01115-x