Category: Axillary

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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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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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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

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Comparative study between fractional laser assisted drug delivery of botulinum toxin versus botulinum toxin injection in primary palmar and axillary hyperhidrosis

Arch Dermatol Res. 2025 Jan 13;317(1):241. doi: 10.1007/s00403-024-03715-5.

ABSTRACT

Palmar hyperhidrosis is common condition that is challenging to treat. Nonsurgical treatments include topical antiperspirants, iontophoresis, anticholinergic drugs and botulinum toxin injections. To evaluate the safety and efficacy of ablative fractional laser therapy, combined with topically applied botulinum toxin versus its injection for the treatment of hyperhidrosis. This study included 40 patients with pimary hyperhydrosis divided into two groups. Group A (n = 20) diagnosed with primary axillary hyperhidrosis was further subdivided into 2 equal subgroups; for which was used fractional laser assisted drug delivery of botulinum toxin in right axilla and botulinum toxin injection in left axilla. Group B (n = 20) diagnosed with primary palmer hyperhidrosis was further subdivided into 2 equal subgroups; for which was used fractional laser assisted drug delivery of botulinum toxin in right palm and botulinum toxin injection in left palm. There was a statistically significant decrease in the hyperhidrosis disease severity scale (HDSS) in all subgroups after treatment as compared to before treatment. Following 3 months of treatment, the amount of sweat as detected by transepidermal water loss (TEWL) was statistically significantly lower in the injection subgroup in both the axillary group (p = 0.075) and the palmer group (p < 0.001). The use of both botulinum toxin injection and laser assisted botulinum toxin drug delivery were associated with significant improvement in the manifestation, disease severity and quality of life in the cases with both axillary and palmer hyperhidrosis. Fractional CO2 laser-assisted drug delivery (LADD) represents a safe, minimally invasive procedure that enhances the delivery of BTX-A.

PMID:39804494 | DOI:10.1007/s00403-024-03715-5

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Evaluation of Efficacy and Safety of miraDry() Procedure in the Treatment of Primary Axillary Hyperhidrosis

Aesthetic Plast Surg. 2025 Jan 3. doi: 10.1007/s00266-024-04558-1. Online ahead of print.

ABSTRACT

INTRODUCTION: Primary axillary hyperhidrosis significantly impacts the quality of life of affected individuals. miraDry®, a non-invasive local precisely controlled thermal energy procedure, represents a promising treatment option. This retrospective analysis aimed to evaluate the treatment success and patient safety following miraDry® procedure in the treatment of primary axillary hyperhidrosis.

MATERIAL AND METHODS: A total of 139 patients receiving miraDry® procedure from 2019 to 2023 with miraDry® fresh protocol for treatment of excessive axillary hyperhidrosis were analyzed. Subjective assessment was performed before and after treatment using hyperhidrosis disease severity scale (HDSS). Minor test (iodine starch test) was done before treatment and 6 months after treatment to objectively quantify sweat severity. Patients with subjective or objective unsatisfied results after first procedure were scheduled for a second treatment.

RESULTS: The majority of treated patients (84%) could effectively be treated with one single treatment, while only 16% (n = 22) required a secondary intervention. HDSS after treatment completion (single and double treatment) showed a significant improvement (p < 0.001) in subjective evaluation of the treatment success. Minor tests demonstrated a significant reduction in sweat severity (p < 0.001), with 95% of patients experiencing no or minimal sweating after treatment completion. The miraDry® procedure demonstrated a favorable safety profile with typical and transient treatment reactions that mostly resolved within 6 months (94.2%) CONCLUSION: Our data demonstrate that miraDry® procedure is an effective and safe treatment option for primary axillary hyperhidrosis, which results in an immense improvement in quality of life and high satisfaction of affected individuals.

LEVEL OF EVIDENCE II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

PMID:39753871 | DOI:10.1007/s00266-024-04558-1

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Efficacy and safety of sofpironium in treatment of primary hyperhidrosis: a systematic review

J Dermatolog Treat. 2025 Dec;36(1):2441258. doi: 10.1080/09546634.2024.2441258. Epub 2024 Dec 13.

ABSTRACT

BACKGROUND: Primary axillary hyperhidrosis has limited noninvasive and effective treatment, and we present the use of sofpironium bromide as a promising treatment option. We aimed to assess the efficacy and safety of sofpironium in patients with primary hyperhidrosis.

METHODS: We systematically searched the databases for Studies that assessed sofpironium bromide in patients with primary axillary hyperhidrosis. Methodological quality was determined using the Cochrane Risk of Bias Assessment tool and Newcastle-Ottowa scale.

RESULTS: Five studies were included (752 patients). They used 5% sofpironium, except for one study that used 5%, 10%, and 15% sofpironium. Studies have shown a significant difference in the incidence of patients with an HDSS score of 1 or 2 ranging from 53.9% to 86.7% and reported a greater reduction in the mean change in the DLQI score in the sofpironium group. They also noted a more significant reduction in the total gravimetric weight of sweat in the sofpironium group. A 1.5 point or greater improvement in HDSM-Ax score ranged from 48.2% to 69.1%. Serious adverse events were not observed in the intervention group.

CONCLUSION: Sofpironium gel provides notable improvements in symptom severity, sweat reduction, and quality of life, with mostly mild localized adverse events.Hyperhidrosis is relatively common, affecting 4.8% of the US population and negatively affects physical, social, and psychological well-being.Sofpironium bromide is recently approved by the FDA for the treatment of primary axillary hyperhidrosisSofpironium bromide showed promising results in terms of safety and efficacy for treating hyperhidrosisWe systematically assessed the use of sofpironium gel reported in five studies (752 patients)Sofpironium gel provides notable improvements in symptom severity, sweat reduction and quality of life, with mostly mild localized adverse events.

PMID:39668771 | DOI:10.1080/09546634.2024.2441258