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

The effects of sympathectomy ganglion levels on late complications in the treatment of hyperhidrosis

J Minim Access Surg. 2024 Nov 29. doi: 10.4103/jmas.jmas_75_24. Online ahead of print.

ABSTRACT

INTRODUCTION: Pathologically excessive sweating in areas such as the palmar, axillary and/or plantar together with sympathetic hyperactivity that occurs independently of systemic causes is called primary hyperhidrosis. Although primary idiopathic hyperhidrosis can be seen at any age, the disease is most commonly seen in adolescents and young adults. The frequency of male and female genders is usually equal. Some medical and minimally invasive methods can be used in the treatment of primary hyperhidrosis. However, the known curative gold standard treatment method for the disease is thoracoscopic thoracic sympathectomy operation.

PATIENTS AND METHODS: In this study, a total of 150 patients who applied to Trakya University Health Practice and Research Center, Department of Thoracic Surgery, between 15 October 2008 and 15 June 2021 and underwent thoracoscopic thoracic sympathectomy due to the diagnosis of hyperhidrosis were evaluated retrospectively. The patients were separated into two groups. Thoracoscopic thoracic sympathectomy was performed on the T2-T4 in the first group (Group I – n : 88) and on the T3-T5 sympathetic ganglions in the second group (Group II – n : 62).

RESULTS: The median age of patients included in the study was found to be 24 (20.75-28) years. Group I and Group II were similar in terms of gender characteristics, but Group II was older. Our success rate was found to be 92% ( n = 138). There was no mortality, major complication such as bleeding requiring open thoracotomy, chylothorax or Horner’s syndrome in any of the patients. Minor complications were seen in the early and late period of the operation at a low rate. Our overall compensatory hyperhidrosis rate was 52% ( n = 78). Compensatory hyperhidrosis was detected more in Group I, although this was not statistically significant. We determined the overall satisfaction rate of our patients as 87.3% ( n = 133). The satisfaction rates of the patients in Group I and Group II were found to be similar.

CONCLUSIONS: Thoracoscopic thoracic sympathectomy is a fast, safe and minimally invasive treatment method with a low complication rate. More than 90% success and a significant increase in psychosocial condition and professional quality of life can be achieved with this procedure. Future studies are needed to reveal the relationship between operated ganglion levels and the development of compensatory hyperhidrosis.

PMID:39611563 | DOI:10.4103/jmas.jmas_75_24

Patient satisfaction after miraDry() treatment for axillary hyperhidrosis. Results of an online patient survey after miraDry() treatment to reduce excessive axillary sweating

GMS Interdiscip Plast Reconstr Surg DGPW. 2024 Oct 15;13:Doc06. doi: 10.3205/iprs000188. eCollection 2024.

ABSTRACT

Hyperhidrosis, with a prevalence of 1 to 2% of the population, primarily affects young people under 40 years of age. The individually perceived burden of odor and amount of sweat leads to a reduced quality of life. In recent years, conservative and surgical measures have been used to treat hyperhidrosis. The miraDry® method based on microwave technology is a non-invasive treatment that enables comparable results in terms of effectiveness while at the same time reducing the burden. In the Park-Klinik Birkenwerder, 282 hyperhidrosis patients were treated with the miraDry® method between 2017 and 2024. An online survey was conducted in May and June 2024. 220 patients were contacted, the results of 80 patients are available (response rate: 36.4%). Changes in the restrictions caused by increased sweating in various areas of life were asked before and after the treatment. In addition, the assessment of general quality of life before and after the treatment was compared. There is a significant reduction in restrictions and a corresponding increase in quality of life after treatment with miraDry®. Satisfaction with the method is high, which is reflected in a high recommendation rate of over 80%.

PMID:39559459 | PMC:PMC11570828 | DOI:10.3205/iprs000188

Single-port Thoracoscopic Laser Sympathicotomy for Primary Hyperhidrosis: A Safe and Minimally Invasive Approach With Favorable Short-term Outcomes

Surg Laparosc Endosc Percutan Tech. 2024 Nov 11. doi: 10.1097/SLE.0000000000001340. Online ahead of print.

ABSTRACT

OBJECTIVE: Thoracoscopic sympathicotomy is a well-established treatment for severe palmar hyperhidrosis. This study evaluates the safety and efficacy of a novel one-stage, bilateral, single-port laser sympathicotomy with minimal dissection.

METHODS: We retrospectively reviewed 73 patients with severe palmar hyperhidrosis who underwent this novel surgical technique between June 2023 and October 2023. Outcomes included complications, recurrent hyperhidrosis, and compensatory hyperhidrosis (CH). Hyperhidrosis severity was assessed using the hyperhidrosis disease severity score (HDSS).

RESULTS: The mean patient age was 21.3 ± 7.7 years, with a female predominance (52.1%). Sympathicotomy was performed at the T3 level only in 46 patients (63%), with the remaining undergoing sympathicotomy at both T3 and T4 levels. Median cauterization and operating times were 78 seconds and 8.7 minutes, respectively. No complications occurred. Two patients experienced recurrent hyperhidrosis during a median follow-up of 9 months, both were mild (HDSS grade 1). CH developed in 41 patients (56.2%), with all occurring within the first month postoperatively. The most common sites for CH were the back (51.2%), chest (43.9%), thigh (41.5%), abdomen (36.6%), and lower leg (36.6%). The majority of patients with CH (95.1%) reported mild (HDSS grade 1) or moderate (HDSS grade 2) hyperhidrosis. A higher body mass index was a significant risk factor for CH (odds ratio: 1.36, 95% CI: 1.12-1.71 for every 1 kg/m2 increase).

CONCLUSIONS: This minimally invasive, single-port thoracoscopic laser sympathicotomy appears to be safe and effective for patients with palmar primary hyperhidrosis. Future studies should investigate long-term outcomes and refine the technique to minimize invasiveness even further.

PMID:39523766 | DOI:10.1097/SLE.0000000000001340

Comparative study of CT-guided radiofrequency and alcohol ablation in the treatment of primary hyperhidrosis

Front Surg. 2024 Oct 28;11:1402241. doi: 10.3389/fsurg.2024.1402241. eCollection 2024.

ABSTRACT

OBJECTIVE: This study compared the efficacy and complications of percutaneous radiofrequency ablation with anhydrous alcohol ablation of sympathetic nerves in treating hyperhidrosis of the head and palms.

METHODS: A retrospective analysis was conducted on 54 patients with primary hyperhidrosis in our department from June 2018 to June 2021, divided into a radiofrequency ablation group (30 cases) and an anhydrous alcohol ablation group (24 cases). Treatment outcomes were compared by analyzing the number of CT scans, effectiveness, and complications.

RESULTS: In the radiofrequency group, symptoms of bilateral hyperhidrosis significantly improved in 24 patients, with an 80% postoperative satisfaction rate. In the alcohol ablation group, symptoms significantly improved in 19 patients postoperatively, with a 79.2% satisfaction rate. There was no statistically significant difference in effectiveness or complications between the two groups (all P > 0.05). The number of CT scans in the radiofrequency group was 4.60 ± 0.56 and 6.08 ± 0.28 in the alcohol group, showing a statistically significant difference (P < 0.05).

CONCLUSION: This study concluded that both percutaneous radiofrequency ablation and alcohol ablation are effective methods for hyperhidrosis treatment, with similar effectiveness and complication rates, but the radiofrequency ablation group required fewer CT scans.

PMID:39534691 | PMC:PMC11555560 | DOI:10.3389/fsurg.2024.1402241

Pharmacologic properties and results of a clinical study of oxybutynin hydrochloride lotion (APOHIDE() Lotion 20%) as a novel treatment for primary palmar hyperhidrosis

Nihon Yakurigaku Zasshi. 2024;159(6):413-422. doi: 10.1254/fpj.24037.

ABSTRACT

APOHIDE® Lotion 20% is a topical agent for treating primary palmar hyperhidrosis that contains the active ingredient oxybutynin hydrochloride. Oxybutynin hydrochloride has anticholinergic effects and inhibits sweating by binding to the M3 receptor, a subtype of the muscarinic acetylcholine receptor, in eccrine sweat glands. The clinical response to oxybutynin hydrochloride treatment also involves N-desethyloxybutynin, an active metabolite of oxybutynin. A clinical study in Japanese patients with primary palmar hyperhidrosis showed superiority of APOHIDE® Lotion 20% over placebo, i.e., there were significantly more responders (i.e., patients with a reduction in sweat volume ≥50% from baseline) in the APOHIDE® Lotion 20% group (APOHIDE® Lotion 20% group: 52.8%, placebo group: 24.3%; treatment difference: 28.5%; P < 0.001, Fisher’s exact test). This and other clinical studies reported some adverse events (AEs) associated with the drug’s anticholinergic effects and some application site AEs, but most of the AEs were mild. Clinical response did not decrease with long-term (52-week) treatment, and only a few patients (2 of 125) discontinued treatment because of AEs. Taken together, study results indicate that APOHIDE® Lotion 20% may be an effective and safe new treatment option for patients with primary palmar hyperhidrosis.

PMID:39496419 | DOI:10.1254/fpj.24037

A Pivotal Study on the Safety and Effectiveness of a Targeted Alkali Thermolysis Patch for Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating

Dermatol Surg. 2024 Oct 31. doi: 10.1097/DSS.0000000000004472. Online ahead of print.

ABSTRACT

BACKGROUND: One-third of US adults are bothered by excessive sweating, approximately 5% are diagnosed with hyperhidrosis. A topical patch using targeted alkali thermolysis (TAT) was developed for treatment of this condition.

OBJECTIVE: This study was intended to assess the efficacy and safety of the TAT-Patch for axillary sweat reduction.

MATERIALS AND METHODS: A randomized, multicenter, double-blind, sham-controlled, pivotal trial enrolled 120 subjects to a bilateral axillary treatment with a TAT patch (63 subjects) or sham patch (57 subjects).

RESULTS: The primary end point was achieved; 64% of TAT-treated versus 44% of sham-treated subjects (p = .0332) improved from Hyperhidrosis Disease Severity Scale (HDSS) 3/4 to HDDS 1/2 at 4 weeks. Targeted alkali thermolysis treatment also showed a statistically significant improvement over sham treatment for all secondary end points, including gravimetric sweat production and subject-reported quality-of-life (QoL) assessments. The duration of effect is approximately 3 months, determined by the time to return to baseline HDSS. Mild-to-moderate treatment-site adverse events (AEs) were reported in 22% of TAT patch subjects. No serious or severe AEs were reported.

CONCLUSION: HDSS, GSP, and QoL findings confirm clinically meaningful sweat reduction and a significant improvement in quality of life following a single TAT patch treatment. This device has potential to offer a new, noninvasive treatment option that is well tolerated with minimal downtime.

PMID:39480962 | DOI:10.1097/DSS.0000000000004472

Iontophoresis Improves the Impact on the Quality of Life of Children with Primary Hyperhidrosis-A Prospective Study and a Short Review

Children (Basel). 2024 Oct 17;11(10):1253. doi: 10.3390/children11101253.

ABSTRACT

BACKGROUND: Primary hyperhidrosis (PH) is a somatic and idiopathic pediatric skin disease. The eccrine glands are tiny and very numerous, with approximately 3 million distributed throughout the skin. There is no commonly accepted amount of sweating to define hyperhidrosis, but people with this disease suffer real limitations integrating into society, which can be quantified through quality of life measurement scales. We want to draw attention to this disease and its impact on children’s quality of life because it is significant and there are no studies conducted on groups consisting solely of children.

METHODS: There are various quality of life evaluation questionnaires for hyperhidrosis. We studied 103 children with hyperhidrosis by monitoring their sweat severity and its impact on quality of life, using the Hyperhidrosis Disease Severity Scale. We compared the scale results before and after 10 days of iontophoresis. This study includes only children under 18 years old, treated with iontophoresis.

RESULTS: The average age of the group is 11.84 ± 2.89 years. Treatment success is recorded in 68 (66.02%) children, but a change in the score is recorded in 74 (71.84%) children. The average HDSS score at T0 is 2.95 ± 0.70, compared to the HDSS score at T1 of 1.92 ± 0.86.

CONCLUSIONS: Hyperhidrosis has a negative impact on daily life, especially self-esteem, occupational productivity, emotional well-being, and interpersonal relationships. Iontophoresis is a safe and effective treatment method that reduces the severity of hyperhidrosis and increases the quality of life.

PMID:39457218 | DOI:10.3390/children11101253

Sexual effects and long-term outcomes of endoscopic lumbar sympathectomy for plantar hyperhidrosis in men: a cross-sectional study

J Vasc Bras. 2024 Sep 27;23:e20240014. doi: 10.1590/1677-5449.202400142. eCollection 2024.

ABSTRACT

BACKGROUND: Plantar hyperhidrosis (PHH) is a disease with high psychosocial impact, and endoscopic lumbar sympathectomy (ELS) has been shown to be the best choice for treatment, but with some concerns such as compensatory sweating (CS) and sexual effects (SE), particularly in men.

OBJECTIVES: The aim of this study is to evaluate the long-term effectiveness of ELS for controlling PHH in men, its side effects, and perceived sexual modifications.

METHODS: A cross-sectional study including only male patients operated for PHH with ELS between 2014-2022 at a private practice. During remote interviews, patients were asked about symptoms before and after ELS and about the postoperative effects on PHH. They were also objectively asked about any SE during the postoperative period. Validated quality of life for hyperhidrosis and erectile function questionnaires were also administered.

RESULTS: 10 male patients averaging 4.26±2.86 years post-ELS were interviewed. Eight of them (80%) achieved complete response (≥80% of sweat reduction) in the first month after surgery and this response was maintained up to the interview date. Two patients had partial response. In six patients, CS occurred, with 5 reporting it as non-troublesome. Six patients reported some type of SE, but none reported erectile dysfunction. Regarding the functional results, all patients rated ELS from good (10%) to very good (30%) or excellent (60%).

CONCLUSIONS: Endoscopic lumbar sympathectomy was effective for treatment of plantar hyperhidrosis in these patients, improving their quality of life and providing lasting PHH control, with some transient sexual dysfunctions that did not impair their sexual life.

PMID:39421693 | PMC:PMC11486464 | DOI:10.1590/1677-5449.202400142