Category: Topical

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Topical glycopyrronium tosylate in Japanese patients with primary axillary hyperhidrosis: A randomized, double-blind, vehicle-controlled study

J Dermatol. 2021 Oct 11. doi: 10.1111/1346-8138.16188. Online ahead of print.

ABSTRACT

Glycopyrronium tosylate cloth, an anticholinergic drug, has been approved for the topical treatment of primary axillary hyperhidrosis in the USA, but its effects in Japanese patients have not been previously investigated. This 4-week, randomized, double-blind, vehicle-controlled, multicenter study was conducted to evaluate the efficacy and safety of glycopyrronium tosylate cloth for primary axillary hyperhidrosis patients in Japan. Eligible patients, who were ≥9 years of age and had primary axillary hyperhidrosis ≥6 months, with gravimetrically-measured sweat production ≥50 mg/5 min, and Hyperhidrosis Disease Severity Scale ≥3 (moderate) were randomized 1:1:1 to once daily topical glycopyrronium tosylate 3.75%, 2.5%, or vehicle. Overall, 497 patients (163 in the glycopyrronium tosylate 3.75% group, 168 in the glycopyrronium tosylate 2.5% group, and 166 in the vehicle group, hereinafter in this order) were randomized. Statistically higher proportions of patients in the glycopyrronium tosylate groups achieved ≥2-point improvement in Hyperhidrosis Disease Severity Scale and ≥50% reduction in sweat production from baseline versus vehicle at week 4 (51.6%, 41.1%, and 16.4%, respectively; p < 0.001 in both cases). Higher responder rates in the glycopyrronium tosylate groups compared with the vehicle group occurred as early as week 1. The most common treatment-emergent adverse events in patients treated with glycopyrronium tosylate were photophobia, mydriasis, thirst, and dysuria. Most treatment-emergent adverse events were mild as determined by the investigators. The incidence of treatment-emergent adverse events leading to treatment modification was low in the three groups. The 4-week use of topical glycopyrronium tosylate improved the patient-reported outcome measure Hyperhidrosis Disease Severity Scale and objectively-evaluated sweat production with a favorable benefit/risk profile.

PMID:34636057 | DOI:10.1111/1346-8138.16188

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Treatment of Axillary hyperhidrosis

J Cosmet Dermatol. 2021 Aug 20. doi: 10.1111/jocd.14378. Online ahead of print.

ABSTRACT

BACKGROUND: Axillary hyperhidrosis characterized by excessive sweating in the axillary regions is a frustrating chronic autonomic disorder leading to social embarrassment, impaired quality of life and usually associated with palmoplantar hyperhidrosis. Identifying the condition and its cause is central to the management.

AIM: The aim of this article is to discuss treatment options for axillary hyperhidrosis.

METHODS: Comprehensive literature search using PubMed and Google Scholar was performed to review relevant published articles related to diagnosis and treatment of axillary hyperhidrosis.

RESULTS: Treatment modalities for axillary hyperhydrosis vary from topical and systemic agents to injectables, newer devices and surgical measures. None except for physical measures using devices or surgery, which destroys the sweat glands to remove them, is possibly permanent and most are associated with attendant side effects.

CONCLUSION: Several treatments including medical and surgical option are available for the treatment of axillary hyperhydrosis. Patient education is important component of its management. Individualized approach of management is necessary for optimal outcome of treatment.

PMID:34416078 | DOI:10.1111/jocd.14378

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Hyperhidrosis and the risk of being treated for skin infections

J Dermatolog Treat. 2021 Jun 21:1-25. doi: 10.1080/09546634.2021.1944971. Online ahead of print.

ABSTRACT

Background A few studies have described an increased prevalence of skin infections in individuals with hyperhidrosis compared to others. However, it remains uncertain whether hyperhidrosis is an independent risk factor for skin infections.Objective To compare the risk of skin infections in individuals with and without hyperhidrosis.Methods In this retrospective cohort study, data on hyperhidrosis were collected from the Danish Blood Donor Study. Blood donors included in 2010-2019 were followed from inclusion until December 2019. Data on redeemed prescriptions against skin infections were collected from the National Prescription Register. The intensity of prescription-use by hyperhidrosis status was assessed in Andersen-Gill models.Results Overall, 4,176 (9.6%) of 43,477 blood donors had self-reported hyperhidrosis and 437 (0.34%) of 127,823 blood donors had hospital diagnosed hyperhidrosis. Self-reported hyperhidrosis was associated with the use of antibiotic prescriptions (adjusted hazard ratio =1.21; 95% confidence interval 1.00-1.45, p = 0.047). Hospital diagnosed hyperhidrosis was associated with the use of antibiotic (adjusted hazard ratio =1.33; 95% confidence interval 1.03-1.68, p = 0.028) and topical antifungal prescriptions (adjusted hazard ratio =1.43; 95% confidence interval 1.04-1.97, p = 0.027).Conclusions Hyperhidrosis is associated with the use of prescriptions for antibiotics and topical antifungals. This suggests a clinically relevant association between hyperhidrosis and skin infections.

PMID:34152896 | DOI:10.1080/09546634.2021.1944971

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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&rsquo;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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Primary hyperhidrosis in children: A review of therapeutics

Pediatr Dermatol. 2021 Mar 4. doi: 10.1111/pde.14551. Online ahead of print.

ABSTRACT

Primary hyperhidrosis, an idiopathic disease that commonly affects the palms, soles, axillae, or craniofacial region, is characterized by perspiration in excess of what is required for physiologic cooling. This disease begins in childhood or adolescence and negatively impacts emotional, physical, and psychologic well-being. This review explores current therapeutic options for primary hyperhidrosis in the pediatric population, including topical therapies, oral therapies, non-surgical and procedural interventions, and adjunctive therapies. In addition, this review identifies new and emerging treatments and highlights the need for further research and therapeutic options for this impactful disease.

PMID:33660889 | DOI:10.1111/pde.14551

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Long-term Effectiveness of Microwave Thermoablation in Persons With Residual Limb Hyperhidrosis: A Case Series

Mil Med. 2021 Feb 25:usab083. doi: 10.1093/milmed/usab083. Online ahead of print.

ABSTRACT

Excessive sweating or focal hyperhidrosis (HH) of the residual limb in persons with amputations is thought to be a significant contributor to residual limb dermatoses, prosthesis dysfunction, and decreased quality of life. Treatment algorithms used for HH in persons without amputation do not effectively translate to residual limb HH, and research in this area is sparse. We discuss the long-term outcomes of three patients treated with microwave thermoablation (MT) on their residual limbs who had previously been unsuccessfully managed with topical antiperspirants and botulinum toxin injections. On average, there was a decrease of two points in the Hyperhidrosis Severity Scale score among the three patients 4-6 years after treatment. Although the reported side effects of post-procedure edema and prolonged time out of a prosthesis are challenging, MT of the residual limb appears to be a promising treatment modality for persons with amputation. Further investigations for standardized treatment guidelines are required to improve management of residual limb HH with MT.

PMID:33629722 | DOI:10.1093/milmed/usab083

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A 1% glycopyrronium bromide cream for the topical treatment of primary axillary hyperhidrosis: Efficacy and Safety Results from a Phase 3a Randomised Controlled Study.

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A 1% glycopyrronium bromide cream for the topical treatment of primary axillary hyperhidrosis: Efficacy and Safety Results from a Phase 3a Randomised Controlled Study.

Br J Dermatol. 2021 Jan 14;:

Authors: Abels C, Soeberdt M, Kilic A, Reich H, Knie U, Jourdan C, Schramm K, Heimstaedt-Muskett S, Masur C, Szeimies RM

Abstract
BACKGROUND: Effective topical treatment options for patients with primary axillary hyperhidrosis are limited. Recent phase 1 trial showed promising results regarding efficacy and safety for topical cream containing glycopyrronium bromide (GPB).
OBJECTIVE: To assess efficacy, safety and tolerability of a 4-week topical treatment with 1% GPB cream in subjects with primary axillary hyperhidrosis compared to placebo.
METHODS: 171 patients (84 placebo; 87 1% GPB) with primary axillary hyperhidrosis were included in this 4 week, multicenter, randomised, double-blind, placebo-controlled Phase 3a part of the pivotal study. Sweat production was measured by gravimetry. Patients rated disease impact using the Hyperhidrosis Disease Severity Scale (HDSS) and Hyperhidrosis Quality of Life Index (HidroQoL© ).
RESULTS: Absolute change in sweat production from baseline to day 29 in logarithmic values was significantly larger in the 1% GPB group than in the placebo group (p=0.0038). The improvement in HidroQoL© exceeded minimal clinically important difference of 4. The proportion of responders was two-fold higher than for placebo for sweat reduction, HDSS and HidroQoL© (-197.08 mg GPB vs. -83.49 mg placebo; 23% GPB vs 11.9% placebo and 59.8% GPB vs. 26.2% placebo respectively). Treatment was safe, most TEAEs were mild or moderate and transient. Local tolerability was very good with 9.2% of patients having only mild or moderate application site reactions. The most reported ADR was dry mouth (16.1%), an expected anticholinergic effect of the treatment.
CONCLUSION: 1% GPB cream may provide an effective new treatment option exhibiting a good safety profile for patients with primary axillary hyperhidrosis. The long-term open-label part (Phase 3b) is ongoing.

PMID: 33445205 [PubMed – as supplied by publisher]

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Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis.

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Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis.

Clin Pharmacokinet. 2021 Jan 12;:

Authors: Pariser DM, Lain EL, Mamelok RD, Drew J, Mould DR

Abstract
BACKGROUND: Glycopyrronium tosylate (GT; Qbrexza® [glycopyrronium] cloth, 2.4%) is a topical anticholinergic approved (USA) for primary axillary hyperhidrosis in patients aged ≥ 9 years.
OBJECTIVE: The objective of this study was to compare the pharmacokinetics and safety of GT to oral glycopyrrolate (phase I study) and assess the relationship between glycopyrronium pharmacokinetics and anticholinergic-related adverse events or efficacy with population pharmacokinetics using data from two phase II studies.
METHODS: In the phase I study, study staff applied GT to axillae of patients with primary axillary hyperhidrosis (aged 9-65 years) once daily (5 days); oral glycopyrrolate was administered to healthy adults (aged 18-65 years) every 8 hours (15 days). In the phase II studies (NCT02016885 [20 December, 2013], NCT02129660 [2 May, 2014]), adults with primary axillary hyperhidrosis applied topical glycopyrronium (0.8-3.2%) or vehicle to axillae once daily (4 weeks). Pharmacokinetic and adverse event data were collected in all studies.
RESULTS: Glycopyrronium pharmacokinetic parameters were similar between adult and pediatric patients treated with GT; there was no evidence of accumulation. Systemic absorption of glycopyrronium was lower with GT vs oral glycopyrrolate. No anticholinergic-related adverse events occurred with GT in the phase I study, while dry mouth and nasal dryness occurred with oral glycopyrrolate; anticholinergic adverse events occurred in the phase II studies. In the population pharmacokinetic analysis, frequency/severity of anticholinergic-related adverse events increased with higher glycopyrronium concentration; no relationship was observed between efficacy and pharmacokinetic measures.
CONCLUSIONS: These studies indicate limited absorption of GT compared to oral glycopyrrolate and a low risk of anticholinergic adverse events with proper GT administration when following instructions for use (wipe each underarm once with same cloth, wash hands, avoid ocular contact).

PMID: 33433785 [PubMed – as supplied by publisher]