Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis: A Profile of Its Use.

Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis: A Profile of Its Use.

Clin Drug Investig. 2019 Sep 30;:

Authors: Lamb YN

Abstract
Glycopyrronium tosylate (Qbrexza™) is available as single-use, pre-moistened cloths and has been approved in the USA for the topical treatment of primary axillary hyperhidrosis in adults and children ≥ 9 years of age. Glycopyrronium tosylate is effective in reducing patient-reported severity of disease and gravimetrically measured sweat production in this patient population; improvements have been shown to be maintained throughout long-term treatment (up to 48 weeks). Glycopyrronium tosylate is generally well tolerated, with most adverse events being mild to moderate in severity. Glycopyrronium tosylate thus provides a self-administered, non-invasive alternative to topical antiperspirant therapy and clinic-based treatments in adults with primary axillary hyperhidrosis, and is the only alternative to topical antiperspirants specifically approved in children and adolescents ≥ 9 years of age.

PMID: 31571127 [PubMed – as supplied by publisher]

Primary hyperhidrosis prevalence and characteristics among medical students in Rio de Janeiro.

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Primary hyperhidrosis prevalence and characteristics among medical students in Rio de Janeiro.

PLoS One. 2019;14(9):e0220664

Authors: Ribeiro Santos Morard M, Betanho Martins R, Lopes Ribeiro AC, Guimarães Rocha Lima P, Dos Santos Carvalho B, Junior JCBS

Abstract
BACKGROUND: Hyperhidrosis is a pathological condition defined by excessive sweating beyond thermoregulatory physiological needs, which can cause substantial psychological impact and impairment of daily activities. Studies regarding its prevalence, however, are scarce and vary widely in their findings. The population of medical students is a particularly interesting subset for its recurring demand of physical contact during patient examination or procedures, and the potential for professional adversity. We aimed at furthering the comprehension of this disease prevalence and characteristics among medical students.
METHODS: Questionnaires inquiring about the presence and characteristics of Primary Hyperhidrosis (PH) were applied through either written or digital means to all eligible medical students enrolled in three Medical Schools in the State of Rio de Janeiro who agreed to take part in the study. Demographic data regarding gender, ethnicity, current age, weight and height was collected in addition to clinical data (sweat site, age of onset, familial history, severity and previous treatments). Severity was evaluated through the Hyperhidrosis Disease Severity Scale (HDSS) and a symptoms survey.
FINDINGS: Our response rate was roughly 1/3 of all eligible students (900/2700). PH prevalence was 20.56% (185/900). It was similar between men and women (23.08% and 19.41%, respectively) and strongly associated with family history of the disease (Prevalence Ratio of 4.27). Regarding ethnicity, of the total sample 73.78% (664/900) self-declared white, among which 19.28% (128/664) had PH. Mixed-race and other ethnicities encompassed 26.22% (236/900) of the sample, among which 24.15% (57/236) had PH. Most positive subjects (64.32%) presented associated forms of PH. Overall involvement of each site (both associated and isolated) was: 63.78% axillary, 50.81% palmar, 43.24% plantar, 20.54% craniofacial, 18.38% facial flushing and 2.16% gustatory sweating. Mean current age was 23.11(±4.04) years for PH patients, and age of onset was ≤18 years in 93.94% of cases. Regarding body mass index (BMI), 71.09% of PH patients had BMI<25kg/m2 and only 4.69% presented BMI≥30kg/m2, none ≥35kg/m2. Some degree of life quality impairment was reported by 89.20% of PH patients, and 23.89% had HDSS 3 or 4 (moderate to severe).
CONCLUSIONS: PH prevalence among Rio de Janeiro medical students was 20.56%, similar between men and women, predominating associated presentations, axillary, palmar and plantar sites, strong familial history, age of onset before 18 years, and some degree of life impairment.

PMID: 31518360 [PubMed – in process]

[Video-assisted thoracoscopic treatment for two ports for idiopathic palmar and axillary hyperhidrosis in children].

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[Video-assisted thoracoscopic treatment for two ports for idiopathic palmar and axillary hyperhidrosis in children].

Cir Pediatr. 2019 Jul 29;32(3):115-120

Authors: González López SL, Díaz Juárez M, Cabrera Machado CA, García González M, Cortiza Orbe GM, Quintero Delgado Z

Abstract
JUSTIFICATION: Primary hyperhidrosis is a benign disease that consists in the excessive production of sweat, mainly in the hands, axillas and feet. It may to interfere with the social and work life of the sufferer. It affects up to 3% of the population. In Cuba there are no epidemiological studies on its prevalence. One of the treatment modalities is videothoracoscopic sympathicotomy.
OBJECTIVES: To describe the results of the videothoracoscopic sympathicotomy technique for two ports using apneic oxygenation to achieve lung collapse.
METHOD: Descriptive, retrospective study of 27 cases operated by primary hyperhidrosis in the period from May 2015 to June 2018. Demographic and clinical characteristics of operated patients, results of the endoscopic surgical technique, postoperative complications and satisfaction were described.
RESULTS: The 27 patients were adolescents with ages ranging from 11 to 19 years old, it was more frequent in the female sex. All patients had total solution of the symptoms in the intraoperative period, demonstrated by the cessation of sweat in the palms or axillas and by the verification of the increase of the palmar temperature in the monitor. No patient had intraoperative complications. Compensatory sweating occurred in four patients and one had intercostal neuritis. 100% of the patients were satisfied with the result at 30 days of treatment.
CONCLUSIONS: It is a safe technique, with few complications, high satisfaction with the results and feasible to perform in pediatric hospitals with basic resources of minimal access surgery.

PMID: 31486302 [PubMed – in process]

Duration of Efficacy Increases with the Repetition of Botulinum Toxin A Injections in Primary Axillary Hyperhidrosis: A 15-year Study in 117 Patients.

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Duration of Efficacy Increases with the Repetition of Botulinum Toxin A Injections in Primary Axillary Hyperhidrosis: A 15-year Study in 117 Patients.

Acta Derm Venereol. 2019 Aug 27;:

Authors: Berthin C, Maillard H

Abstract
Changes in the duration of efficacy of botulinum toxin A injections for primary axillary hyperhidrosis have not been studied in depth. The aim of this study was to assess such changes. In a retrospective cohort of 220 patients, seen over a 17-year period, duration of efficacy was recorded, including duration of efficacy of first and last injections. Of 220 patients, 117 fulfilled the study criteria (79 females and 38 males, age 17-79 years, mean age 38.3 years). Patients received 3-24 injections (mean 5.5). The duration of efficacy of the first injections was 3 weeks to 30 months (median 6 months), and the duration of efficacy of the final injections was 3 weeks to 66 months (median 8 months) (p < 0.001). An increase in duration of efficacy occurred in 62% of patients. Of the 20 patients with a follow up ≥10 years, the mean number of treatments was 8.25/patient; in 18 of these patients the duration of efficacy increased by > 50%. In conclusion, repeated botulinum toxin A injections lead to an increase in duration of efficacy without secondary decrease.

PMID: 31453629 [PubMed – as supplied by publisher]

Safety and efficacy of topical formulations containing 0.5, 1 and 2% glycopyrronium bromide in patients with primary axillary hyperhidrosis: a randomised, double-blind, placebo-controlled study.

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Safety and efficacy of topical formulations containing 0.5, 1 and 2% glycopyrronium bromide in patients with primary axillary hyperhidrosis: a randomised, double-blind, placebo-controlled study.

Br J Dermatol. 2019 Jun 19;:

Authors: Masur C, Soeberdt M, Kilic A, Knie U, Abels C

Abstract
primary hyperhidrosis (HH), a dysregulation of the parasympathetic nerve system, is characterized by focal symmetrical sweating of axillae, palms or the plantar region.1 Hyperhidrosis is a chronic condition with severe impact on patients’ quality of life, however, more than 50% of hyperhidrosis patients receive no treatment.1,2 Overall prevalence was reported to be 16% in German adults, with axillary hyperhidrosis being the most common form of HH.2 The objective of this study was to assess safety and tolerability, efficacy and pharmacokinetics, of escalating concentrations of glycopyrronium bromide (GPB), a competitive antagonist of muscarinic acetylcholine receptor mAChR, in subjects with axillary hyperhidrosis. This article is protected by copyright. All rights reserved.

PMID: 31218668 [PubMed – as supplied by publisher]

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]

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]

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]

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]