The comparative study of letibotulinum toxin A and onabotulinum toxin A in treatment of primary axillary hyperhidrosis

Arch Dermatol Res. 2025 Apr 1;317(1):661. doi: 10.1007/s00403-025-04069-2.

ABSTRACT

Primary axillary hyperhidrosis (PAH) is a challenging condition characterized by excessive underarm sweating. The U.S. Food and Drug Administration has approved onabotulinum toxin A (OnaBTX-A, Botox®, Allergan Inc, USA) as the only botulinum toxin treatment for severe axillary hyperhidrosis, and it has demonstrated positive results. Recently, the off-label use of letibotulinum toxin A (LetiBTX-A, Hugel®, Hugel Inc, Korea) has risen significantly for cosmetic purposes due to its effectiveness. For the treatment of primary axillary hyperhidrosis, the authors proposed that LetiBTX-A is at least as effective as OnaBTX-A. To evaluate the efficacy and safety of letibotulinum toxin A (LetiBTX-A) in comparison to onabotulinum toxin A (OnaBTX-A) for treating primary axillary hyperhidrosis (PAH). All participants with a diagnosis of moderate to severe primary axillary hyperhidrosis (Hyperhidrosis Disease Severity Scale (HDSS) score ≥ 2) received random injections of 50 U of LetiBTX-A in one armpit and 50 U of OnaBTX-A in the other site. HDSS score and hyperhidrosis area were measured by using the Minor’s iodine starch test. Participant satisfaction was evaluated at 1, 3, and 6 months following the injection. Onset of action and adverse events were also assessed. All 30 participants completed the study protocol, with the mean age was 34.44 ± 7.82 years and most of the participants were female. The mean age at onset was 20.47 ± 3.01 years and more than 50% of participants had a HDSS score of 3. There was no statistically significant difference observed in the reduction of HDSS scores, hyperhidrosis area, and participant satisfaction between the axillae treated with LetiBTX-A and those treated with OnaBTX-A at 1, 3 and 6 months after injections. The median onset of action of both LetiBTX-A and OnaBTX-A were 2 ± 1 day (p = 0.317). Procedure-related pain was comparable between 2 formulations (P = 0.876). No serious adverse event was observed. This study concluded that LetiBTX-A and OnaBTX-A demonstrate comparable efficacy and safety profiles in treating primary axillary hyperhidrosis (PAH).

PMID:40167830 | DOI:10.1007/s00403-025-04069-2

Effectiveness of Sofpironium Bromide in Patients with Primary Axillary Hyperhidrosis Who Experienced Residual or Recurrence of Axillary Odor after Surgery for Axillary Osmidrosis

J Plast Reconstr Surg. 2024 Jul 5;4(1):13-19. doi: 10.53045/jprs.2023-0067. eCollection 2025 Jan 27.

ABSTRACT

OBJECTIVES: Sofpironium bromide is the first topical anticholinergic drug approved in Japan for the treatment of primary axillary hyperhidrosis. This study aimed to investigate the effectiveness of sofpironium bromide in patients with primary axillary hyperhidrosis who experienced residual axillary odor or recurrence of axillary odor after surgery with subdermal excision of apocrine glands by skin flap procedure for axillary osmidrosis.

METHODS: A total of 56 patients who underwent surgery for axillary osmidrosis at our hospital between January 2022 and April 2023 were included in this study. Axillary odor and sweat volume were evaluated with patient-reported visual analog scale in 56 patients who underwent surgery for axillary osmidrosis and 13 patients administered with sofpironium bromide after the surgery.

RESULTS: Surgery in patients with axillary osmidrosis significantly improved axillary odor and excessive sweating by approximately 90% and approximately 54%, respectively. Treatment with sofpironium bromide in patients with axillary hyperhidrosis after the surgery significantly improved axillary odor and excessive sweating by approximately 70% and approximately 63%, respectively.

CONCLUSIONS: These results suggest that sofpironium bromide is effective in patients with axillary hyperhidrosis after the surgery. Since this study was conducted with a small number of patients in a retrospective single-arm design, it is necessary to validate the results in a prospective controlled study with a large number of patients.

PMID:40160959 | PMC:PMC11950559 | DOI:10.53045/jprs.2023-0067

CT-guided Percutaneous Ethanol Sympatholysis for Hyperhidrosis: How I Do It

Radiology. 2025 Mar;314(3):e241430. doi: 10.1148/radiol.241430.

ABSTRACT

Hyperhidrosis, excessive sweating from the eccrine sweat glands, is caused by overactivity of the sympathetic nerves. Facial, axillary, and/or palmar hyperhidrosis (excessive sweating of the face, armpits, and hands) has a reported prevalence of 1%-1.6%. This condition is initially treated conservatively using a combination of topical and pharmacologic treatments. Surgical sympathectomy or percutaneous sympatholysis are treatment options for severe hyperhidrosis (grade 3 or 4) that does not respond to conservative management. The aim of intervention is to permanently disrupt the sympathetic signal by targeting the thoracic vertebral levels T2, T3, and T4 of the paravertebral ganglia, located on the anterolateral surface of the vertebral body. This review presents the step-by-step technique for CT-guided percutaneous ethanol sympatholysis and discusses patient selection for the procedure, potential complications, and treatment outcomes. Although more than 90% of patients report complete resolution of hyperhidrosis immediately after sympatholysis, as many as 40% report symptom recurrence within 6 months. The probability of remaining hyperhidrosis-free long term (ie, more than 6 months) after CT-guided sympatholysis is 60%. Procedural risks include a 15% risk of compensatory hyperhidrosis elsewhere in the body, 8% risk of Horner syndrome (mostly self-limiting), 5% risk of pneumothorax, and 3% risk of severe intercostal neuralgia due to nontarget ethanol deposition. Despite the risks, this intervention can be life-altering for those with severe disease.

PMID:40100019 | DOI:10.1148/radiol.241430

Compensatory sweating after thoracoscopic sympathectomy for primary focal hyperhidrosis: a series of 820 cases

Interdiscip Cardiovasc Thorac Surg. 2025 Mar 13:ivaf063. doi: 10.1093/icvts/ivaf063. Online ahead of print.

ABSTRACT

OBJECTIVES: Primary hyperhidrosis is a functionally and socially limiting condition. Thoracoscopic sympathectomy is an effective treatment for hyperhidrosis. However, post-sympathectomy compensatory sweating remains a challenge in clinical practice.

METHODS: Record analysis of patients who underwent thoracoscopic sympathectomy between 2002 and 2020. Emphasis was given to demographic data, site of complaint, functional and social impairment, procedure performed, postoperative results, and compensatory sweating.

RESULTS: A total of 820 patients were included (age 23.8 [7.3] years, body mass index-BMI 22.3 [3.0] kg/m2, 66.3% female). The palmoplantar (44.3%) and palmoplantar-axillary (41.6%) sites were the most affected, followed by the axillary (12.3%) and craniofacial sites (1.8%). On a 0 to 4 scale, functional impairment was significantly greater in the palmoplantar group (p < 0.001) and social impairment in the axillary, palmoplantar-axillary, and craniofacial groups (p < 0.001). The degree of compensatory sweating after surgery was minimal in groups palmoplantar (74.9%), palmoplantar-axillary (70.4%), axillary (63.4%), and mild in the craniofacial group (66.7%). The bivariate analyses showed significant differences in the compensatory sweating variable for age, sex, BMI, and site. The multiple analysis by logistic regression showed BMI, sex, and the palmoplantar-axillary, axillary, and craniofacial variables to be significant for compensatory sweating.

CONCLUSIONS: Thoracoscopic sympathectomy was an effective procedure for controlling primary focal hyperhidrosis, with tolerable compensatory sweating in the patients analyzed in this study.

PMID:40080705 | DOI:10.1093/icvts/ivaf063

Systemic effect of sympathectomy in the treatment of localized hyperhidrosis

Updates Surg. 2025 Mar 10. doi: 10.1007/s13304-025-02163-8. Online ahead of print.

ABSTRACT

Hyperhidrosis is thought to result from excessive stimulation of sweat glands due to increased sympathetic activity; however, data on systemic responses following bilateral thoracic sympathectomy as the definitive treatment have not yet been sufficiently evaluated. This study, designed as a prospective cohort investigation, included 24 patients who underwent sympathectomy for palmar and axillary hyperhidrosis at our center in 2023, along with an age-matched control group of equal size. In the sympathectomy group, pupillometry measurements were performed 1 day before surgery and on the 7th postoperative day, while the control group underwent measurements at corresponding intervals. Data from the sympathectomy group were analyzed both preoperatively and postoperatively and compared with the control group. According to the Hyperhidrosis Disease Severity Scale, all patients had severe hyperhidrosis. Sympathectomy was performed at the T3 level in 9 patients and at both T3 and T4 levels in 15 patients. The postoperative satisfaction rate was recorded as 95.8%. No statistically significant differences were observed between preoperative pupillometry measurements of the sympathectomy group and those of the control group. However, when comparing preoperative and postoperative data within the sympathectomy group, significant differences favoring increased parasympathetic activity were noted in the latency of contractions and photopic low values (p = 0.016 and p = 0.038, respectively). Our study is one of the pioneering works to objectively demonstrate, through a quantitative method, that sympathectomy for hyperhidrosis enhances the parasympathetic system response in the ocular region.

PMID:40064815 | DOI:10.1007/s13304-025-02163-8

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

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

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

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