Category: Axillary

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A phase III, 52-week, open-label study to evaluate the safety and efficacy of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis

J Dermatol. 2021 May 26. doi: 10.1111/1346-8138.15927. Online ahead of print.

ABSTRACT

A long-term study was conducted in Japanese patients with primary axillary hyperhidrosis who completed the preceding 6-week phase III, confirmatory study of 5% sofpironium bromide gel (hereinafter referred to as sofpironium) to evaluate the safety and efficacy of 52-week treatment with sofpironium. In the long-term study, 185 patients who completed the confirmatory study (94 and 91 patients in the vehicle and sofpironium groups, respectively) started to receive sofpironium (switching and extension groups, respectively), and all these patients were included in both the full analysis set (FAS) and the safety analysis set (SAF). In the FAS, there were more females than males (73.0% vs. 27.0%), and median age was 38.0 years. A total of 161 patients (86 and 75 patients in the switching and extension groups, respectively) completed the study at week 52. The proportions of patients with hyperhidrosis disease severity score of 1 or 2 and a 50% or more reduction in total gravimetric weight of sweat were 57.4% in the switching group and 58.2% in the extension group at week 52. The proportions of patients who achieved this efficacy end-point in the long-term study were similar to that (53.9%) in the sofpironium group in the confirmatory study. In the SAF, the incidences of adverse events (AEs) were 80.9% in the switching group and 83.5% in the extension group, and the incidences of adverse drug reactions were 39.4% and 45.1%, respectively. AEs that occurred in at least 20% of patients in both treatment groups were application site dermatitis (25.5% and 33.0%, respectively) and nasopharyngitis (31.9% and 23.1%, respectively). Reported AEs were generally mild, and there were no deaths. Serious AEs occurred in three patients, but none were considered related to the study drug. In this study, the efficacy of sofpironium was maintained during 52-week treatment, and no new safety risk was observed.

PMID:34041788 | DOI:10.1111/1346-8138.15927

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Pathological Changes in Axillary Hyperhidrosis and Axillary Osmidrosis Induced by Microwave Treatment: Comparison of Single- and Double-Pass Irradiation

Lasers Surg Med. 2021 May 26. doi: 10.1002/lsm.23412. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: To analyze histopathological changes and degree of damage to the axillary tissue due to single- and double-pass irradiation therapy using a microwave energy-based device. STUDY DESIGN/MATERIALS AND METHODS: We included 15 axillary hyperhidrosis and axillary osmidrosis patients who received microwave irradiation therapy between March 2017 and March 2019. Ten patients underwent single-pass irradiation and five underwent double-pass irradiation, after which skin samples were collected from the right and left axillae for pathological analysis. Samples were taken in a consistent manner from Patient 6 onwards and a comparative study of five single-pass and five double-pass patients was conducted (n = 10).

RESULTS: Histopathological analysis showed destruction and fibrosis in addition to necrosis and damage to the adipose tissue in apocrine and eccrine sweat glands. In the superficial microvasculature, blood vessel wall damage and thrombus formation were observed as well as damage in the hair follicles and hair bulbs. No obvious damage was observed in the epidermis and nerves. The amount of damage to sweat glands was higher in patients undergoing double-pass instead of single-pass irradiation.

CONCLUSION: From a histopathological point of view, microwave energy-based irradiation therapy can be considered efficient, as there was no damage to epidermis and nerves and favorable destruction of apocrine and eccrine glands. As the amount of damaged sweat glands was higher after double-pass irradiation, it can be considered more effective than single-pass irradiation. Lasers Surg. Med. © 2021 Wiley Periodicals LLC.

PMID:34036606 | DOI:10.1002/lsm.23412

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Management of Primary Focal Hyperhidrosis: An Algorithmic Approach

J Drugs Dermatol. 2021 May 1;20(5):523-528. doi: 10.36849/JDD.5774.

ABSTRACT

Hyperhidrosis (HH) is defined as perspiration beyond the level required to maintain temperature regulation. HH affects nearly 4.8% of the population in the United States. It can have a great impact on patient’s quality of life by disturbing daily activity, performance, confidence, social interactions, and mental health. In the majority of patients with HH (93%), the etiology of excess sweating is idiopathic, which classifies it as primary focal HH. Mild HH may be controlled with topical antiperspirants and lifestyle modifications. Based on the location of involvement, iontophoresis and botulinum toxin may be considered if the patient does not respond to topical therapies. Despite minimizing sweating, chronic use of systemic anticholinergics, in particular oxybutynin, may result in detrimental adverse effects such as dementia. Local surgery, radiofrequency, microwave, and lasers are other potential modalities for HH. Sympathectomy can be a last resort for the treatment of focal HH of the palmar, plantar, axillary, and craniofacial areas after failure of less invasive therapeutic options. In this review, we conducted a comprehensive search in the PubMed electronic database to summarize an algorithmic approach for the treatment of HH. This can help broaden options for managing this difficult disease. J Drugs Dermatol. 20(5): doi:10.36849/JDD.5774.

PMID:33938689 | DOI:10.36849/JDD.5774

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Treatment of primary axillary hyperhidrosis with a cream formulation of oxybutynin chloride 10

J Eur Acad Dermatol Venereol. 2021 Apr 23. doi: 10.1111/jdv.17297. Online ahead of print.

ABSTRACT

Primary focal hyperhidrosis is a common disorder with a significant impact on quality of life1 . Topical anticholinergics are an emerging therapeutic class in the treatment of focal hyperhidrosis. Glycopyrronium tosylate 3.75% cloth was FDA approved for the treatment of axillary hyperhidrosis in adults and children aged 9 years or older in 2018.

PMID:33893675 | DOI:10.1111/jdv.17297

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Thoracoscopic bilateral dorsal sympathectomy for primary palmo-axillary hyperhidrosis short- and mid-term results

J Minim Access Surg. 2021 Apr 8. doi: 10.4103/jmas.JMAS_174_20. Online ahead of print.

ABSTRACT

BACKGROUND: Thoracoscopic bilateral dorsal sympathectomy is the standard of care for primary palmo-axillary hyperhidrosis. This study aims at studying the surgical outcomes with special emphasis on the incidence of compensatory hyperhidrosis (CH) after thoracoscopic dorsal sympathectomy. Post-procedural patient satisfaction as well as quality of life was measured and analysed.

MATERIALS AND METHODS: This is a retrospective analysis of sixty thoracoscopic dorsal sympathectomy surgeries in thirty patients in a tertiary level thoracic surgery centre over 2 years. Various peri-operative variables were recorded and assessed. Incidence of CH was noted and analysed in relation to patient satisfaction and record was made of quality of life at the time of discharge, at 3 months and 1-year follow-up following surgery.

RESULTS: We performed sixty video-assisted thoracoscopic sympathectomies in 30 patients. The mean operative time was 44.93 ± 10 min. The mean hospital stay was 1 day. There were no immediate post-procedural complications. All the patients had complete resolution of palmar and axillary hyperhidrosis. Fifty per cent of our patients (15/30) had some degree of CH after surgery. Quality-of-life measurement showed very good satisfaction by 100% at discharge, by 93.3% at 3 months and at 1 year. Those 6.66% of patients were partially satisfied/not satisfied because of the presence of moderate-to-severe CH.

CONCLUSION: A significant percentage of the patients with primary palmo-axillary hyperhidrosis will be very satisfied with the procedure at 1 year after surgery despite 50% of them developing CH. Detailed counselling regarding CH in the pre-operative period would minimise the dissatisfaction rate after surgery.

PMID:33885020 | DOI:10.4103/jmas.JMAS_174_20

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Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax): Evaluation of Measurement Performance

J Drugs Dermatol. 2021 Apr 1;20(4):410-418. doi: 10.36849/JDD.2021.5569.

ABSTRACT

BACKGROUND: Clinical trials of primary axillary hyperhidrosis (AHH) require rigorous measurement of AHH severity from the patient’s perspective. Previously, we reported conceptualization and item content development for the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale.

OBJECTIVE: To evaluate the psychometric performance and estimate clinically meaningful change scores for the HDSM-Ax in a Phase IIb clinical study of sofpironium bromide gel for AHH.

METHOD: HDSM-Ax measurement performance was analyzed in trial response data using two psychometric paradigms: Classical Test and Rasch Measurement Theories (CTT; RMT). HDSM-Ax meaningful change scores were estimated from anchor-based methods using two global summary questions of hyperhidrosis severity and the Hyperhidrosis Disease Severity Score (HDSS).

RESULTS: HDSM-Ax satisfied CTT and RMT criteria as a fit-for-purpose outcome measure in AHH clinical trials. Within-person anchor-based analyses indicated a 1-point change in HDSM-Ax severity score (range, 0–4) represents a clinically meaningful change in AHH severity.

CONCLUSION: HDSM-Ax is a well-defined and reliable measure of AHH severity. A 1-point change in HDSM-Ax score is clinically meaningful. J Drugs Dermatol.20(4):410-418. doi:10.36849/JDD.5569.

PMID:33852243 | DOI:10.36849/JDD.2021.5569

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Bilateral one-stage single-port sympathicotomy in primary focal hyperhidrosis, a prospective cohort study: treat earlier?

J Cardiothorac Surg. 2021 Mar 25;16(1):50. doi: 10.1186/s13019-021-01430-0.

ABSTRACT

BACKGROUND: Primary Focal Hyperhidrosis (PFH) has a detrimental effect on Quality of Life. Repetitive, non-curative symptomatic strategies dominate current treatment of PFH, in spite of the availability of an effective and permanent curative treatment like Endoscopic Thoracic Sympathectomy (ETS). Current surgical optimization may allow for a re-established position of sympathetic modulation in this treatment algorithm. We sought to evaluate the safety, effectiveness, and long-term results of a Bilateral One-stage Single-port Sympathicotomy (BOSS) procedure in PFH patients and to identify subgroups benefitting most.

METHODS: Prospective analysis of 163 patients, 35 (21.5%) underwent Rib-3 (R3) BOSS for palmar PFH, 58 (35.6%) R3-R5 BOSS for axillary PFH and 70 (42.9%) R3-R5 BOSS for combined palmar/axillary PFH. Effectiveness was measured using Skindex-29 and the Hyperhidrosis Disease Severity Scale (HDSS).

RESULTS: Overall Skindex-29-rating (46.5 ± 14.8 preoperatively vs 20.1 ± 20.6 postoperatively, p < 0.001), and HDSS score (3.71 ± 0.45 preoperatively vs 1.82 ± 0.86 postoperatively, p < 0.001) indicated a significant improvement in health-related quality of life after BOSS. R3 BOSS was superior to R3-R5 BOSS in terms of HDSS score (1.49 vs 1.91 respectively, p = 0.004) and in terms of severe compensatory hyperhidrosis, a frequently reported side-effect (17.1% vs 32.8% respectively, p < 0.001). No major complications occurred.

CONCLUSIONS: BOSS is safe, effective, and offers a long-term curative solution in the treatment of PFH. Especially in the palmar PFH subgroup, R3 BOSS treatment results compare favorably to the treatment results of non-curative alternatives published in the current literature. Therefore, R3 BOSS should be offered to all patients with severe PFH, reporting insufficient benefit of treatment options such as oral and/or local agents.

PMID:33766091 | DOI:10.1186/s13019-021-01430-0

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Effects of lower thoracic sympathicotomy on plantar hyperhidrosis

J Thorac Dis. 2021 Feb;13(2):664-670. doi: 10.21037/jtd-20-2437.

ABSTRACT

BACKGROUND: The purpose of this study was to investigate whether performing lower thoracic sympathicotomy (LTS) from T10 to T12 affects plantar hyperhidrosis in patients with palmo-plantar (PP) or palmo-axillary-plantar (PAP) hyperhidrosis.

METHODS: Between January 2015 and January 2020, all consecutive patients with primary hyperhidrosis who underwent bilateral thoracoscopic sympathicotomy and met the inclusion criteria were included. Sympathicotomy was performed using one of the following two methods: the conventional upper thoracic vs. expanded thoracic sympathicotomy. In the expanded thoracic sympathicotomy, we expanded the level of sympathicotomy ranging from R5 to R12 in addition to the conventional upper thoracic sympathicotomy (R3 or R4). In cases of the expanded thoracic sympathicotomy, we defined the LTS as a sympathicotomy of the levels ranging from R10 to R12, which are related to plantar hyperhidrosis.

RESULTS: A total of 103 subjects with PP (71 cases) or PAP (32 cases) hyperhidrosis were included. Palmar or axillary hyperhidrosis in all patients were alleviated after sympathicotomy. There was no difference in sweating decrease or CH according to the hyperhidrosis types or sympathicotomy techniques. In addition, no-LTS was performed in 77 cases and LTS was performed in 26 cases. In the no-LTS group, there were 65 and 12 cases of low and high degrees of CH, respectively. In the LTS group, there were 22 and four cases of low and high degrees of CH, respectively. There was no significant difference in CH between the no-LTS and LTS groups (P=0.981). Improvement in plantar hyperhidrosis in the no-LTS group was observed in 29 of 77 cases, while improvement in plantar hyperhidrosis in the LTS group was observed in 16 of 26 cases. The addition of LTS lead to significant improvement in plantar hyperhidrosis (P=0.034).

CONCLUSIONS: Performing LTS is a safe and feasible procedure that improved plantar sweating more so than it did in cases that did not undergo LTS. Therefore, we cautiously suggest that adding LTS helps in the treatment of plantar hyperhidrosis combined with palmar hyperhidrosis. Further studies on LTS are needed to validate these findings and will be helpful in establishing management guidelines.

PMID:33717539 | PMC:PMC7947522 | DOI:10.21037/jtd-20-2437