Category: Treatment

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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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CT-guided thoracic sympathicolysis versus VATS sympathectomy in the therapeutic concept for severe primary palmar Hyperhidrosis

Thorac Cardiovasc Surg. 2021 Apr 15. doi: 10.1055/s-0041-1725205. Online ahead of print.

ABSTRACT

BACKGROUND: The objective was to compare computed tomography (CT)-guided thoracic sympathicolysis (CTSy) and video-assisted thoracoscopic sympathectomy (VATS) with regard to their feasibility, the occurrence of minor and major complications, and the clinical outcome.

MATERIALS AND METHODS: In this study, 88 patients treated by CTSy and 86 patients treated by VATS were retrospectively included. CTSy was performed after establishing the entry plane below the level of the intervertebral space T2/3 via a dorsolateral approach using a 22-G coaxial needle. On average of 5 mL of a sympathicolytic mixture was instilled. VATS was performed under intubation anesthesia. After insertion of the instruments via a minithoracotomy, the parietal pleura was dissected and the sympathetic trunk severed below T2. The interventions were performed unilaterally, the contralateral side being treated after approximately 6 weeks. All patients evaluated their sense of discomfort before treatment as well as 2 days, 6, and 12 months after, on the basis of a Dermatology Quality of Life Index and additionally the side effects that occurred.

RESULTS: Both treatments led to a marked reduction of symptoms, whereby mild recurrent sweating occurred over the further course, significantly higher in the CTSy patient group. Short-term miosis and ptosis were rarely found in both groups. As the most common side effect, transient compensatory sweating was reported by 16/88 patients after CTSy and 10/86 patients after VATS. Pneumothoraces developed postoperatively in 7/86 cases. Temporary pain after thoracotomy was experienced by 12/86 patients.

CONCLUSION: For patients with palmar hyperhidrosis, CTSy and VATS represented a minimally invasive treatment option that provided a high and largely equivalent level of benefit.

PMID:33860510 | DOI:10.1055/s-0041-1725205

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Effect of botulinum toxin in stellate ganglion for craniofacial hyperhidrosis: a case report

J Int Med Res. 2021 Mar;49(3):3000605211004213. doi: 10.1177/03000605211004213.

ABSTRACT

Craniofacial hyperhidrosis causes sweating of the face and scalp due to excessive action of the sweat glands and manifests when patients become tense/nervous or develop an elevated body temperature. If noninvasive treatments are ineffective, invasive treatments such as a sympathetic block and resection are considered. A 32-year-old woman with no specific medical history was referred for uncontrolled craniofacial hyperhidrosis that included excessive sweating and hot flushing. Physical examination showed profuse sweating, and infrared thermography showed higher temperature in the neck and face than in the trunk. The patient underwent several stellate ganglion blocks, and her symptoms improved; however, the treatment effect was temporary. Botulinum toxin was then injected into the stellate ganglion. At the time of this writing, her sweating had been reduced for about 6 months and she was continuing to undergo follow-up. Craniofacial hyperhidrosis is a clinical condition in which patients experience excessive sweating of their faces and heads. It is less common than palmar and plantar hyperhidrosis. Botulinum toxin injection into the stellate ganglion is simple and safe and produces longer-lasting effects than other treatments, such as endoscopic sympathectomy and a single nerve block.

PMID:33788638 | DOI:10.1177/03000605211004213

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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