Category: Axillary

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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

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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

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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

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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

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Longitudinal validity of the Hyperhidrosis Quality of Life Index (HidroQoL) in a phase IIIb clinical trial population with hyperhidrosis: responsiveness and meaningful change

Br J Dermatol. 2024 Oct 28:ljae415. doi: 10.1093/bjd/ljae415. Online ahead of print.

ABSTRACT

BACKGROUND: The Hyperhidrosis Quality of Life Index (HidroQoL ©) is a well-developed patient-reported outcome measure assessing the quality of life (QoL) impacts in hyperhidrosis, which has proven very good measurement properties, such as structural validity and internal consistency.

OBJECTIVES: We aimed to investigate responsiveness over time and estimate values for meaningful within-person change (MWPC) towards symptom improvement for different measurement time points (4 and 12 weeks), extending the existing validity evidence in patients with primary axillary hyperhidrosis.

METHODS: Data (from a phase IIIb clinical trial) was collected at baseline, week 4, week 8, week 12, week 28, week 52, and week 72. For the assessment of responsiveness, HidroQoL change scores were correlated with corresponding change scores of the Hyperhidrosis Disease Severity Scale (HDSS), the Dermatology Life Quality Index (DLQI), and the gravimetric sweat production based on a-priori formulated hypotheses. Furthermore, it was tested whether the different HDSS change score groups differed significantly from each other over time and whether the HidroQoL was sensitive towards these group differences over time. This was extended by the calculation of matched-pair tests and effect sizes to test significance for each change group separately. For the estimation of MWPC thresholds towards symptom improvement, different anchor-based and integrated approaches were used.

RESULTS: In total, the sample was composed of 357 patients with primary axillary hyperhidrosis. For the assessment of responsiveness, 5 out of 14 a-priori hypotheses regarding the correlation of the change scores could be confirmed, whereas the rejected hypotheses only marginally differed from the expected values. Furthermore, regarding responsiveness, the HidroQoL showed sensitivity towards symptom improvement at each measurement time point. Effect sizes were large as expected (d ≥ 0.806). MWPC thresholds towards symptom improvement were proposed for two measurement time points: 5 (week 4) and 6 (week 12). Increasing MWPC values over time were observed.

CONCLUSION: This study extends the evidence for the longitudinal validity of the HidroQoL up to 72 weeks and proposed MWPC thresholds for different time intervals (4 and 12 weeks) after baseline, aiding interpretability. Results concur with findings from previous validation studies.

PMID:39467334 | DOI:10.1093/bjd/ljae415

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Efficacy and safety of topical glycopyrronium bromide in treating axillary hyperhidrosis: systematic review and meta-analysis

Sci Rep. 2024 Oct 19;14(1):24537. doi: 10.1038/s41598-024-74430-4.

ABSTRACT

BACKGROUND: Hyperhidrosis (HH), characterized by excessive sweating, poses a significant challenge to patients’ quality of life. This meta-analysis evaluates the safety and efficacy of topical glycopyrronium bromide (GBP) in treating primary hyperhidrosis, a chronic condition affecting various body regions. Despite its prevalence, primary axillary hyperhidrosis is often undertreated due to a lack of awareness and social stigma.

METHODS: Following PRISMA guidelines, we conducted a systematic review and meta-analysis of randomized controlled trials comparing GBP to a placebo in primary hyperhidrosis patients. Eligibility criteria included outcomes related to perspiration suppression and symptom improvement.

RESULTS: Four RCTs involving 1401 patients were included. GBP significantly increased Hyperhidrosis Disease Severity Scale (HDSS) responders (RR = 2.33, 95% CI [1.99 to 2.74], p < 0.00001) and Axillary Sweating Daily Diary (ASDD/ASDD-C) responders (MD = 3.07, 95% CI [2.32 to 4.06], p < 0.002) without significantly causing adverse events. Dermatology life quality index was also significantly improved in the GBP group (MD = -2.32, 95% CI [-3.09, -1.55], P < 0.00001).

CONCLUSION: GBP demonstrated effectiveness in reducing sweat production while improving HDSS and DLQI scores. Adverse events included dry mouth and anticholinergic effects. Dry eye and local skin reactions were not significant, which makes GBP promising in managing primary hyperhidrosis, offering improvements in symptoms and quality of life. While adverse events should be considered, further research with larger sample sizes and long-term follow-up is warranted for comprehensive clinical integration.

PMID:39424822 | DOI:10.1038/s41598-024-74430-4