Category: Axillary

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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.

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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]

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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]

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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]

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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.

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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]

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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]

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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]

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The quality of life and satisfaction rate of patients with upper limb hyperhidrosis before and after bilateral endoscopic thoracic sympathectomy.

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The quality of life and satisfaction rate of patients with upper limb hyperhidrosis before and after bilateral endoscopic thoracic sympathectomy.

Saudi J Anaesth. 2019 Jan-Mar;13(1):16-22

Authors: Hajjar WM, Al-Nassar SA, Al-Sharif HM, Al-Olayet DM, Al-Otiebi WS, Al-Huqayl AA, Hajjar AW

Abstract
Background: Hyperhidrosis is a functional disorder identified by excessive sweating. Its incidence is approximately 1% in any population. Bilateral endoscopic thoracic sympathectomy (BETS) intervention is the definitive treatment of choice for palmar and axillary hyperhidrosis.
Aims and Objectives: The purpose of this study is to evaluate and compare the quality of life (QOL) and satisfaction rate of patients with upper limb hyperhidrosis before and after BETS surgery and the influence of compensatory hyperhidrosis (CH) on patients’ QOL after surgery.
Settings and Design: This study is a cross-sectional study designed to generate longitudinal data.
Subjects and Methods: This study is a cross-sectional study designed to generate longitudinal data pre- and postbilateral BETS prospectively. This study was conducted in the surgery department of University Hospital in Riyadh, Saudi Arabia. Hundred patients with upper limb hyperhidrosis who underwent BETS from 2014 to 2017 were included. A modified and validated QOL questionnaire for hyperhidrosis was completed by the patients themselves in order to compare the QOL for patients both before and after BETS. Patients’ satisfaction and the occurrence of CH were obtained postoperatively.
Statistical Analysis Used: Data were analyzed using the SPSS® statistical package for social studies, version 22.0 (SPSS 22; IBM Corp., New York, NY, USA) for Windows®.
Results: A total of 100 patients completed the questionnaire; 94% of patients had a positive QOL outcome after the surgery. The mean decrease in QOL scores was -42.0 points toward better QOL. The site of sweating had a significant effect on the patients’ QOL before and after the surgery (P value < 0.001). Moreover, 76% of patients reported a high satisfaction rate.
Conclusion: Primary hyperhidrosis can negatively impair patients’ QOL in different domains. BETS showed to be an effective option for improving the QOL of patients and it provided both short- and long-term effectiveness in treating upper limb hyperhidrosis. CH did not interfere with the rate of patient satisfaction or their QOL postoperatively.

PMID: 30692883 [PubMed]

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Effectiveness of bilateral clipping of the thoracic sympathetic chain for the treatment of severe palmar and/or axillary hyperhidrosis and facial flushing.

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Effectiveness of bilateral clipping of the thoracic sympathetic chain for the treatment of severe palmar and/or axillary hyperhidrosis and facial flushing.

Cir Esp. 2019 Jan 23;:

Authors: Fibla Alfara JJ, Molins López-Rodó L, Hernández Ferrández J, Guirao Montes Á

Abstract
INTRODUCTION: Division of the thoracic sympathetic chain is the standard treatment for severe palmar and/or axillary hyperhidrosis and facial flushing. Clipping is an alternative option which allows the block to be reverted in cases of intolerable compensatory sweating.
METHODS: This is a prospective study performed to assess: a) results of clipping of the thoracic sympathetic chain in patients with palmar and/or axillary hyperhidrosis and facial flushing; and b) to determine the improvement obtained after removal of the clip in patients with unbearable compensatory sweating. We included 299 patients (598 procedures) diagnosed with palmar hyperhidrosis (n=110), palmar and/or axillary hyperhidrosis (n=78), axillary hyperhidrosis (n=35), and facial flushing (n=76), who underwent videothoracoscopic clipping between 2007 and 2015.
RESULTS: 128 men and 171 women were treated, with mean age of 28 years. A total of 290 patients (97.0%) were discharged within 24hours. The procedure was effective in 92.3% (99.1% in palmar hyperhidrosis, 96,1% in palmar and/or axillary hyperhidrosis, 74.3% in axillary hyperhidrosis, and 86.8% in facial flushing). Nine patients (3%) presented minor complications. Compensatory sweating developed in 137 patients (45.8%): moderate in 113 (37.8%), severe in 16 (5.3%) and unbearable in 8 (2.7%). The clip was removed in these 8 patients; symptoms improved in 5 (62.8%), with sustained effect on hyperhidrosis in 4 of them.
CONCLUSIONS: Clipping of the thoracic sympathetic chain is an effective and safe procedure. If incapacitating compensatory sweating develops, this technique allows the clips to be removed with reversion of symptoms in a considerable number of patients.

PMID: 30685056 [PubMed – as supplied by publisher]

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Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials.

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Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials.

Pediatr Dermatol. 2018 Nov 19;:

Authors: Hebert AA, Glaser DA, Green L, Werschler WP, Forsha DW, Drew J, Gopalan R, Pariser DM

Abstract
OBJECTIVES: Hyperhidrosis in pediatric patients has been understudied. Post hoc analyses of two phase 3 randomized, vehicle-controlled, 4-week trials (ATMOS-1 [NCT02530281] and ATMOS-2 [NCT02530294]) were performed to assess efficacy and safety of topical anticholinergic glycopyrronium tosylate (GT) in pediatric patients.
METHODS: Patients had primary axillary hyperhidrosis ≥ 6 months, average Axillary Sweating Daily Diary (ASDD/ASDD-Children [ASDD-C]) Item 2 (sweating severity) score ≥ 4, sweat production ≥ 50 mg/5 min (each axilla), and Hyperhidrosis Disease Severity Scale (HDSS) ≥ 3. Coprimary end points were ≥ 4-point improvement on ASDD/ASDD-C Item 2 (a validated patient-reported outcome) and change in gravimetrically measured sweat production at Week 4. Efficacy and safety data are shown through Week 4 for the pediatric (≥ 9 to ≤ 16 years) vs older (> 16 years) subgroups.
RESULTS: Six hundred and ninety-seven patients were randomized in ATMOS-1/ATMOS-2 (GT, N = 463; vehicle, N = 234); 44 were ≥ 9 to ≤ 16 years (GT, n = 25; vehicle, n = 19). Baseline disease characteristics were generally similar across subgroups. GT-treated pediatric vs older patients had comparable improvements in ASDD/ASDD-C Item 2 (sweating severity) responder rate, HDSS responder rate (≥ 2-grade improvement]), sweat production, and quality of life (mean change from Baseline in Dermatology Life Quality Index [DLQI]/children’s DLQI), with greater improvement vs vehicle. Treatment-emergent adverse events were similar between subgroups, and most were mild, transient, and infrequently led to discontinuation.
CONCLUSIONS: Topical, once-daily GT improved disease severity (ASDD/ASDD-C, HDSS), sweat production, and quality of life (DLQI), with similar findings in children, adults, and the pooled population. GT was well tolerated, and treatment-emergent adverse events were qualitatively similar between subgroups and consistent with other anticholinergics.

PMID: 30451318 [PubMed – as supplied by publisher]