Category: Treatment

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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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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

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Predictors of Compensatory Sweating and Satisfaction Following Endoscopic Thoracic Sympathetic Chain Clipping for Palmar/Axillary Hyperhidrosis

J Clin Med. 2025 Jan 8;14(2):326. doi: 10.3390/jcm14020326.

ABSTRACT

Background: Endoscopic thoracic sympathetic chain clipping (ETSC) is a definitive treatment for primary palmar and/or axillary hyperhidrosis (PPAH); however, compensatory sweating (CS) remains a feared complication. The aims of this study were to investigate the factors associated with CS and satisfaction with the treatment and to evaluate the post-operative quality of life (QoL). Methods: From January 2011 to August 2023, 180 patients who had undergone two-stage ETSC were prospectively asked to complete pre- and post-operative questionnaires on satisfaction, CS, and QoL in several daily activities. Results: Seventy-nine patients (45.7%) were male, and fifty-two (30.1%) were active smokers, with a mean body max index (BMI) of 22.6 ± 3.14. The majority of the population (112 (62.2%)) was operated on for combined palmar and axillary primary hyperhidrosis (PH), whereas 56 (31.1%) patients had only palmar and 12 (6.7%) only axillar PH. Only 122 (67.8%) patients completed ETSC on both sides and the follow-up in the study period. CS was 50.8% (62 patients), and there was severe CS in 7 cases (5.7%); 9 (7.4%) patients developed a gustatory CS. The final effectiveness of ETSC was 95.9%, with a reported improvement in QoL in 95.3% of cases (mainly in manual work and socialization); 94.1% of patients were satisfied and would undertake ETSC again. At multivariable analysis, only older age (>24 years) was a predictor of CS (p = 0.007) and severe CS (p = 0.042). No predictor for satisfaction was found. Conclusions: ETS by clipping can improve QoL in cases of palmar/axillary hyperhidrosis. Older patients must be informed of a higher risk of CS.

PMID:39860332 | DOI:10.3390/jcm14020326

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Endoscopic thoracic sympathectomy for primary hyperhidrosis: an over a decade-long follow-up on efficacy, impact, and patient satisfaction

J Thorac Dis. 2024 Dec 31;16(12):8292-8299. doi: 10.21037/jtd-24-1407. Epub 2024 Dec 20.

ABSTRACT

BACKGROUND: Endoscopic thoracic sympathectomy is a well-known and effective treatment for palmar and axillary primary hyperhidrosis (PHH). Its most frequent drawback and the main complaint among patients who underwent surgery is the appearance of compensatory sweating (CS). To date, no long-term studies using internationally standardized tools have assessed the efficacy and impact of this surgery on patients. In this study we performed a very long-term follow-up of the patients using an internationally validated tool. The aim of this article is to assess the technique as a treatment for hyperhidrosis, focusing on its long-term efficacy, side effects (CS), and patient satisfaction with the procedure.

METHODS: A closed cohort study was performed conducting a review of the clinical records to identify 100 consecutive patients who underwent bilateral endoscopic thoracic surgery with a minimum follow-up period of 2 years. Patients with diagnoses other than primary palmar or axillary hyperhidrosis or those for whom follow-up was impossible were excluded. A structured telephone survey, including the International Hyperhidrosis Society “Hyperhidrosis Disease Severity Scale” (HDSS) was conducted for all patients. Data were summarized using median (1st and 3rd quartiles) for quantitative variables and relative and absolute frequencies for qualitative variables. To study the likelihood of a patient recommending the surgery, a Bayesian logistic regression model was used reporting results as odds ratio (OR).

RESULTS: A total of 91 patients were included in the follow-up. The median follow-up duration was 10.66 (5.68, 11.98) years. The most affected zone was the hands (29.67%), and the most common sympathectomy levels were R2 and R3 (68.13%). The overall surgical efficacy rate was of 94.50% and CS appeared in 36.26% of the patients, with 75.76% of these cases being mild and severe in only one patient. In total, 97.8% of patients improved their HDSS score after surgery. The OR of recommending the surgery for a lower HDSS index was 0.24 and 0.18 for the apparition of CS. Despite it, 91.21% of patients recommend the surgery, with an overall satisfaction rate of 93.95%.

CONCLUSIONS: Endoscopic thoracic sympathectomy is an effective and safe treatment for palmar and axillary PHH, with a relatively low rate of CS which, when present, is typically mild, making it a highly satisfactory treatment option for patients.

PMID:39831229 | PMC:PMC11740069 | DOI:10.21037/jtd-24-1407

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Botulinum Toxin-loaded Detachable Dissolvable Microneedles for Primary Axillary Hyperhidrosis: A Pilot Study on Efficacy and Safety

J Clin Aesthet Dermatol. 2025 Jan;18(1):E61-E66.

ABSTRACT

OBJECTIVE: Botulinum toxin injection is a well-established treatment for primary hyperhidrosis. The botulinum toxin-loaded detachable dissolvable microneedles (BoNT-MNs) were developed in a result of disadvantages of the intradermal procedure. This pilot study aims to evaluate the efficacy and safety of BoNT-MNs.

METHODS: This within-subject study included ten adults (N=10; 100% female) with mild primary axillary hyperhidrosis. BoNT-MNs patches were prepared and each microneedle patch contained 15 units of onabotulinum toxin. BoNT-MNs and placebo patches were randomly applied to different sides of axilla. Iodine-starch test, dermatologists’ and patients’ satisfaction scores were assessed at baseline and Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.

RESULTS: All ten female subjects completed the trial. Notably, on the BoNT-MNs side, iodine starch scores exhibited an onset at Week 2, with a 57.14-percent reduction at Week 12, returning to baseline after Week 20. Dermatologists’ and patients’ satisfaction scores were consistently superior to the placebo side from Week 2 and Week 1, respectively, until Week 16, with statistical significance (p<0.05) observed at Week 12 and Week 2.

LIMITATIONS: This study involved a limited number of female participants and administered a single, small dosage of botulinum toxin in the BoNT-MNs.

CONCLUSIONS: Botulinum toxin-loaded detachable dissolvable microneedles patches offer a safe and effective method for reducing axillary sweating.

CLINICAL TRIAL: This study was approved by the Institutional Review Board of Faculty of Medicine, Chulalongkorn University with IRB number 567/63, and registered in the Thai Clinical Trials Registry (Thaiclinicaltrials.org) under registration number TCTR20201230002.

PMID:39830825 | PMC:PMC11741174