A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis.

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A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis.

Am J Clin Dermatol. 2019 May 20;:

Authors: Glaser DA, Hebert AA, Nast A, Werschler WP, Green L, Mamelok RD, Quiring J, Drew J, Pariser DM

Abstract
BACKGROUND: Glycopyrronium tosylate is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years (Qbrexza™ [glycopyrronium] cloth, 2.4%).
OBJECTIVE: This 44-week open-label extension study assessed glycopyrronium tosylate safety and descriptive efficacy in patients completing one of two, phase III, double-blind, vehicle-controlled, 4-week trials (NCT02530281; NCT02530294).
METHODS: Patients aged ≥ 9 years with primary axillary hyperhidrosis were randomized 2:1 (glycopyrronium tosylate: vehicle, once daily) in the double-blind trials. Completers could receive open-label glycopyrronium tosylate for up to an additional 44 weeks. Treatment-emergent adverse events and local skin reactions were assessed. Descriptive efficacy assessments were gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale responder rate (≥ 2 grade improvement), and Dermatology Life Quality Index/children’s Dermatology Life Quality Index.
RESULTS: Of 651 patients completing the double-blind trials, 564 (86.6%) entered the open-label extension; 550 were analyzed. Most patients experiencing treatment-emergent adverse events had mild or moderate events (> 90%). Discontinuation because of treatment-emergent adverse events remained low and relatively stable, with a cumulative rate of 8.0% (44/550) over 44 weeks. Common treatment-emergent adverse events (> 5%) were dry mouth (16.9%), vision blurred (6.7%), application-site pain (6.4%), nasopharyngitis (5.8%), and mydriasis (5.3%). Most patients (67.5%) had no local skin reactions; those occurring were predominantly mild/moderate. Glycopyrronium tosylate efficacy was maintained throughout the trial; at week 44, the Hyperhidrosis Disease Severity Scale responder rate was 63.2%, and improvements from baseline (double blind) in sweat production were - 71.3% and 8.7 ± 6.2/6.2 ± 4.9 for Dermatology Life Quality Index/children’s Dermatology Life Quality Index.
CONCLUSIONS: Daily long-term application of glycopyrronium tosylate for up to 48 weeks (double blind plus open label) was generally well tolerated and efficacy was maintained. No new safety signals emerged.
TRIAL REGISTRY: Clinicaltrials.gov NCT02553798.

PMID: 31111409 [PubMed – as supplied by publisher]

[A retrospective study on the quality of life of patients with primary focal hyperhidrosis that underwent a video-assisted thoracoscopic sympathectomy].

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[A retrospective study on the quality of life of patients with primary focal hyperhidrosis that underwent a video-assisted thoracoscopic sympathectomy].

Rev Port Cir Cardiotorac Vasc. 2019 Jan-Mar;26(1):31-35

Authors: Teixeira J, Moreira R, Vieira M, Miranda JA, Mota JC

Abstract
Backgroud: Primary focal hyperhidrosis affects between 1 to 4% of the general population, with a higher prevalence in teenagers and young adults. The condition is characterized by excessive sweating in 1 or more body part, most often the palms, face, armpits and soles. This condition causes a significant negative impact on patient’s quality of life. The pathophysiology of focal hyperhidrosis is believed to be due to excessive sympathetic stimulation, and videothoracoscopic sympathectomy is a recognized form of treatment. The aim of this study is to evaluate the post-operative quality of life of patients who underwent thoracoscopic sympathectomy.
MATERIALS AND METHODS: This is a retrospective study of fifty-four patients with primary focal hyperhidrosis submitted to bilateral thoracoscopic thoracic sympathectomy at the Center of Cardiothoracic Surgery of Casa de Saúde da Boavista, between January 2011 and December 2014. The Quality of Life questionnaire and the Hyperhidrosis Severity Scale questionnaire were used to evaluate the quality of life in the pre-operative period and 3 months after surgery. Further to this, data was collected regarding medium-term follow-up by telephone. All patients underwent general anesthesia and had bilateral video-assisted thoracoscopic resection of the sympathetic chain.
RESULTS: The majority of patients are females 59.3% (32). The mean age is 30.8 ± 7.70 (between 16 and 49 years). Prior to surgery, 85% of the patients had severe hyperhidrosis. 79.6% of respondents stated that general discomfort was promoted by the condition, with the Funcional-Social domain being the most affected aspect of their life (61.1%). The rates of peri-operative complications and major post-operative complications were null, and minor complications were 5.5%. After 3 months, improvement in patient’s quality of life and satisfaction level were of 100% and 96.3% respectively, however compensatory hyperhidrosis was observed in 53.7% of patients. 57.3% of the patients reported significant improvements in the Funcional-Social domain. Medium-term follow-up (mean=6 years) allowed for the evaluation of 31 patients (57.4% of the population), of whom 77.4% maintained compensatory hyperhidrosis. 93.5% reported to be highly satisfied with the surgical results and claimed to have improved their quality of life by 93.5%. 94% and 94.4% respectively of the patients evaluated in the medium term follow-up and after 3 months and in the medium term follow-up, recommend the surgery.
CONCLUSION: Sympathectomy by video-assisted thoracoscopic surgery (VATS) is an effective and viable therapeutic option for primary focal hyperhidrosis patients. Despite compensatory hyperhidrosis being observed at time, this procedure produces very satisfactory results particularly in regard to the patient’s post-operative quality of life.

PMID: 31104374 [PubMed – in process]

Topical Treatment of Primary Focal Hyperhidrosis, Part 2.

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Topical Treatment of Primary Focal Hyperhidrosis, Part 2.

Int J Pharm Compd. 2019 Mar-Apr;23(2):94-104

Authors: Zur E

Abstract
This represents part 2 of a 2-part article on the topic of primary focal hyperhidrosis. Part 1, which was published in the International Journal of Pharmaceutical Compounding’s January/February 2019 issue, provided a comprehensive review of the active pharmaceutical ingredients aluminum salts and methenamine in the treatment of primary focal hyperhidrosis. Part 2 provides a comprehensive review of the active pharmaceutical ingredients glycopyrronium salts and oxybutynin chloride in the treatment of primary focal hyperhidrosis.

PMID: 31085774 [PubMed – in process]

Hyperhidrosis and Dysautonomia in a Patient with a History of Tetraplegia following Cervical Facet Radiofrequency Ablation: A Case Report.

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Hyperhidrosis and Dysautonomia in a Patient with a History of Tetraplegia following Cervical Facet Radiofrequency Ablation: A Case Report.

PM R. 2019 Apr 15;:

Authors: Reddy R, Zardouz S, Rejai S, Chen J

Abstract
Chronic pain in those with spinal cord injury (SCI) can significantly impact quality of life, with prevalence ranging from 26%-96%1 . Treatment of chronic pain is notoriously challenging and unsatisfactory for providers and patients1,2 . Patients with traumatic SCI and fusion can develop adjacent-level degeneration3 . Facet-mediated pain can be treated with radiofrequency ablation (RFA) of the medial branch nerves that innervate the zygapophyseal joints4 .

PMID: 30985080 [PubMed – as supplied by publisher]

Glycopyrronium Tosylate (Qbrexza) for Hyperhidrosis

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Glycopyrronium Tosylate (Qbrexza) for Hyperhidrosis

Skin Therapy Lett. 2019 Mar;24(2):1-3

Authors: Nwannunu CE, Limmer AL, Coleman K, Shah R, Patel RR, Mui UN, Tyring SK

Abstract
Hyperhidrosis is a condition characterized by excessive sweat production beyond which is physiologically necessary for thermal regulation. Affecting over 4.8% of the United States population, studies have shown that severe primary hyperhidrosis interferes with daily activities and can be considered intolerable, negatively impacting a patient’s quality of life. Glycopyrronium tosylate is a topical anticholinergic agent that reduces sweat production by blocking the activation of acetylcholine receptors in peripheral sweat glands. In clinical trials, topical glycopyrronium tosylate, a pre-moistened cloth containing 2.4% glycopyrronium solution, was shown to be an effective, safe and non-invasive treatment for patients suffering from primary hyperhidrosis. This review examines the clinical trials of topical glycopyrronium tosylate and its role in primary hyperhidrosis. Glycopyrronium tosylate was recently US FDA-approved (as of June 2018) to manage patients with primary axillary hyperhidrosis.

PMID: 30970203 [PubMed – as supplied by publisher]

The Treatment of Primary Focal Hyperhidrosis

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The Treatment of Primary Focal Hyperhidrosis

Skin Therapy Lett. 2018 Jan;24(1):7

Authors: Wechter T, Feldman SR, Taylor SL

Abstract
Primary focal hyperhidrosis is a relatively common disease that has a significant impact on afflicted patient’s quality of life. The pathogenesis of the disease is thought to stem from increased cholinergic activity on eccrine sweat glands. Topical aluminum chloride based antiperspirants are good first-line agents for all affected body sites. Anticholinergic agents are emerging as effective topical alternatives. Iontophoresis passes an electrical current through the skin and is an excellent treatment option for palmoplantar disease. Botulinum toxin type A injections remain a mainstay second-line treatment. Local procedural advances including microwave thermolysis, laser therapy and focused ultrasound are emerging as safe and effective alternatives for refractory disease. Oral anticholinergics are generally well tolerated and can also be used for intractable disease. Last-line interventions include local surgical options and sympathectomy, though some patients may prefer permanent treatment. Further investigation of novel treatments as well as ways to optimize existing therapeutic options are needed.

PMID: 30817880 [PubMed – as supplied by publisher]

Clinical and histological evaluation of a single high energy microwave treatment for primary axillary hyperhidrosis in Asians: A prospective, randomized, controlled, split-area comparative trial.

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Clinical and histological evaluation of a single high energy microwave treatment for primary axillary hyperhidrosis in Asians: A prospective, randomized, controlled, split-area comparative trial.

Lasers Surg Med. 2019 Feb 27;:

Authors: Kaminaka C, Mikita N, Inaba Y, Kunimoto K, Okuhira H, Jinnin M, Kao B, Tanino R, Tanioka K, Shimokawa T, Yamamoto Y

Abstract
BACKGROUND AND OBJECTIVES: Microwave treatment is an effective non-invasive treatment option for primary axillary hyperhidrosis (PAH), but the treatment parameters vary and no histopathological studies have been performed to validate clinical outcomes. This study investigated its efficacy and safety and histopathological changes after a single microwave treatment at the maximum energy level for PAH in Asians.
MATERIALS AND METHODS: A prospective, clinical, and histological split-area randomized controlled trial (RCT) was performed in Japan. Twenty-six subjects underwent a single microwave treatment at the maximum energy level 5 (5.8 GHz/axilla) on the randomized side of axillae. The primary outcome was the mean difference between both sides in the improvement of modified single-underarm Hyperhidrosis Disease Severity Scale (msHDSS) scores over the course of the 12-month study period from baseline. The secondary outcomes were; the percentage of responders with at least a 2-point drop in the msHDSS score of 3 or 4 group or with a 1-point drop in the msHDSS score of 2 group; the percentage of responders with at least a 75% reduction in sweat weight over 12 months; recurrence rate; and adverse effects. We also performed a histological assessment for 13 selected subjects.
RESULTS: Twenty-four subjects completed the study. There were statistically significant differences in improvement of msHDSS scores between the microwave-treated and control sides (P < 0.05) from baseline at 0.5, 1, 3, 6, and 12 months. In the msHDSS score of 3 or 4 group, the percentage of responders with at least a 2-point drop on the microwave-treated side versus control side was 72.2 versus 11.1% (P < 0.05) at 1 month, 83.3 versus 5.6% (P < 0.05) at 3 months, 61.1 versus 38.9% (P = 0.317) at 6 months and 38.9 versus 16.7% (P = 0.264) at 12 months. The percentage of responders with at least a 75% reduction in sweat weight on the microwave-treated side versus control side was 75.0 versus 37.5% at 1 month, 75.0 versus 29.2% at 3 months, 83.3 versus 50.0% at 6 months and 70.8 versus 33.3% at 12 months (all P < 0.05). Recurrence on the microwave-treated side was observed in 4.2% and 12.5% of 24 subjects at 3 and 12 months, respectively. No serious side-effects were noted. Histology showed the diameter and density of secretory eccrine glands and nerve fiber lengths around eccrine glands were significantly decreased after treatment compared to baseline (P = 0.002, 0.027, 0.003, respectively).
CONCLUSIONS: A single-session microwave treatment at the maximum energy level significantly improved the PAH of Japanese patients and had minimal side effects. This technique demonstrates that diminished size of secretory eccrine glands and nerve fiber degeneration could be useful markers for predicting the efficacy of the treatment. Lasers Surg. Med. 9999:1-8, 2019. © 2019 Wiley Periodicals, Inc.

PMID: 30811620 [PubMed – as supplied by publisher]

[Impact of Selective Quality of Life Analysis in Patients with Local Hyperhidrosis after Sympathicus Clipping].

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[Impact of Selective Quality of Life Analysis in Patients with Local Hyperhidrosis after Sympathicus Clipping].

Zentralbl Chir. 2019 Feb 22;:

Authors: Schreiner W, Mykoliuk I, Dudek W, Sirbu H

Abstract
INTRODUCTION: Hyperhidrosis (HH) is associated with physical and psychological restrictions. The treatment includes both conservative and surgical methods and aims to permanently improve the quality of life (QoL) of those affected. Endoscopic sympathetic blockade (ESB) is an established surgical therapeutic method and is considered effective when conservative treatment options fail. The aim of our study was to comprehensively analyse the QoL alteration and patient satisfaction after ESB and to identify the corresponding influencing factors.
METHODS: From July 2008 to April 2016, 105 patients were operated for treatment-refractory HH. In all cases, an ESB was performed according to the HH form and the STS expert consensus (STS: Society of Thoracic Surgeons). QoL and hyperhidrosis status were selectively analysed pre- and postoperatively and evaluated using detailed questionnaires (a self-developed questionnaire, SF36, DLQI, Hyperhidrosis LQ (HidroQoL)). Statistical processing was performed with SPSS Statistics version 21.0.0.2 for Windows (Armonk, NY: IBM Corp.). Descriptive statistical analysis and nonparametric tests were used.
RESULTS: 105 patients who underwent bilateral ESB between July 2008 and April 2016 were evaluated: 73 women (69.5%) and 31 men (29.5%) with median age of 26 years (range: 16 - 64 years). Of the 105 patients who underwent bilateral ESB, 12 patients had focal Hyperhidrosis palmar and axillar (12.4%), 20 had Hyperhidrosis palmo-plantar (19.0%), 47 had Hyperhidrosis palmoplantar and axillar (44.8%), 11 had Hyperhidrosis axillar (10.5%), and 14 had Hyperhidrosis facial (13.3%). HydroQoL scores showed improvement in all forms of HH. All patient groups demonstrated improvement in DLQI, while the LQ analysis of SF36 showed an improvement in social functioning and mental well-being in all forms of HH other than HA. 86.7% of patients (n = 91) were satisfied with their postoperative outcome. Compensatory sweating (CS) was observed in 76.2% of cases (n = 80), without a clear LQ impact. No significant correlation between CS and the hyperhidrosis form was found.
CONCLUSIONS: ESB is associated with a long-time improvement in social functioning, psychological well-being, and high patient satisfaction. The onset of CS has no clear correlation to QoL and patient satisfaction.

PMID: 30795027 [PubMed – as supplied by publisher]

The Etiology, Diagnosis and Management of Hyperhidrosis: A Comprehensive Review. Part II. Therapeutic Options.

The Etiology, Diagnosis and Management of Hyperhidrosis: A Comprehensive Review. Part II. Therapeutic Options.

J Am Acad Dermatol. 2019 Jan 30;:

Authors: Nawrocki S, Cha J

Abstract
Hyperhidrosis (HH) is a chronic disorder of excess sweat production that may have a significant adverse effect on quality of life. A variety of treatment modalities currently exist to manage HH. Initial treatment includes lifestyle and behavioral recommendations. Antiperspirants are regarded as the first-line therapy for primary focal HH and can provide significant benefit. Iontophoresis is considered to be the primary remedy for palmar and plantar HH. Botulinum toxin (BTX) injections are administered at the dermal-subcutaneous junction and serve as a safe and effective treatment option for focal HH. Oral systemic agents are reserved for treatment-resistant cases or for generalized HH. Energy delivering devices such as lasers, ultrasound technology, microwave thermolysis, and fractional microneedle radiofrequency may also be utilized to reduce focal sweating. Surgery may be considered when more conservative treatments have failed. Local surgical techniques, particularly for axillary HH, include excision, curettage, liposuction, or a combination of these techniques. Sympathectomy is the treatment of last resort when conservative treatments are unsuccessful or intolerable, and after accepting secondary compensatory HH as a potential complication. A review of treatment modalities for HH and a sequenced approach are presented.

PMID: 30710603 [PubMed – as supplied by publisher]

Bilateral brachial plexus injury after MiraDry® procedure for axillary hyperhidrosis: a case report.

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Bilateral brachial plexus injury after MiraDry® procedure for axillary hyperhidrosis: a case report.

World Neurosurg. 2019 Jan 28;:

Authors: Puffer RC, Bishop AT, Spinner RJ, Shin AY

Abstract
Multiple treatments are available for primary axillary hyperhidrosis, including non-invasive, microwave based thermal treatments designed to destroy sweat glands in the axilla. Often these procedures involve local anesthetic injection to the axilla, followed by placement of the microwave emitter onto the skin and applying the heat treatment to varying depths of the subcutaneous tissues. CASE REPORT: A 49-year old, thin and active woman (BMI 19.6) underwent microwave based treatment to the bilateral axillary regions. She experienced an electric sensation into the ulnar digits of the right hand during anesthetic injection, and then underwent the microwave thermal treatment. She suffered a bilateral brachial plexus injury with imaging evidence of severe, subcutaneous edema surrounding the nerves of the plexus in the axilla, as well as denervation atrophy of the arm and forearm muscles bilaterally. At the time of evaluation and EMG, 8 months after treatment, she had recovered significant strength in the left upper extremity, but continued to have evidence of a severe radial nerve injury on the right. EMG demonstrated some recovery and observation was recommended followed by secondary reconstruction if required. It is likely that the patient sustained thermal injury to the nerves in the axilla bilaterally, given the close proximity to the skin surface in a patient with a low BMI. CONCLUSION: In thin patients undergoing treatment of primary axillary hyperhidrosis, consideration should be given to the distal brachial plexus which may be at risk of damage with high powered microwave-based therapy.

PMID: 30703585 [PubMed – as supplied by publisher]