Expert Opin Investig Drugs. 2021 Mar 11. doi: 10.1080/13543784.2021.1900114. Online ahead of print.
NO ABSTRACT
PMID:33691553 | DOI:10.1080/13543784.2021.1900114
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
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
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]
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]
Cost-effectiveness of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis.
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Cost-effectiveness of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis.
J Med Econ. 2020 Dec 01;:1
Authors: Bloudek LM, Gillard KK, Nguyen VB, Klein SZ
Abstract
AIMS: Primary axillary hyperhidrosis (PAHH) is a condition characterized by excessive sweating that negatively impacts health-related quality of life, with significant psychological and social impacts. Glycopyrronium tosylate (GT) is a topical anticholinergic approved in the United States for treatment of PAHH in patients 9 years of age and older. Our objective was to assess the cost-effectiveness of GT as first-line topical therapy compared to topical aluminum chloride from a United States commercial perspective.
MATERIALS AND METHODS: A Markov model was developed consisting of four health states based on the Hyperhidrosis Disease Severity Scale (HDSS) over a time horizon of five years with discount rates of 3% for both costs and outcomes. Transitions between health states were driven by HDSS response, defined as an improvement of ≥2 points. Non-responders and those who discontinue could switch to later line treatments or no treatment. Health utility scores were based on HDSS scores, supported by published literature.
RESULTS: Over five years, GT yielded 0.12 greater QALYs and 0.93 greater LYs with response compared to treatment with prescription aluminum chloride at an incremental cost of $10,584. Relative to prescription aluminum chloride, GT resulted in an incremental cost-effectiveness ratio (ICER) of $87,238 per QALY gained, $11,349 per LY with response. The ICER fell below $100,000 for 66% of probabilistic sensitivity analysis simulations and below $150,000 for 82% of simulations.
LIMITATIONS: This analysis represents a simplified scenario of a hypothetical PAHH patient. Due to sparse data, assumptions were required for treatment patterns, efficacy, and persistence.
CONCLUSION: Based on the analysis of incremental cost per QALY gained, GT is may be cost-effective relative to prescription aluminum chloride at commonly accepted willingness to pay thresholds.
PMID: 33256494 [PubMed – as supplied by publisher]
Efficacy and Tolerability of 20% Aluminum Sesquichlorohydrate vs 20% Aluminum Chloride for the Treatment of Axillary Hyperhidrosis: A Randomized Controlled Trial.
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Efficacy and Tolerability of 20% Aluminum Sesquichlorohydrate vs 20% Aluminum Chloride for the Treatment of Axillary Hyperhidrosis: A Randomized Controlled Trial.
Dermatol Ther. 2020 Sep 29;:e14354
Authors: Thianboonsong T, Kanokrungsee S, Paichitrojjana A, Udompataikul M, Kamanamool N, Rojhirunsakool S
Abstract
This study evaluated the efficacy and tolerability of topical aluminum sesquichlorohydrate (AS) when compared to aluminum chloride (AC) as a treatment for primary axillary hyperhidrosis. Twenty subjects were included in this randomized, controlled, split-side 8-week study. All participants applied 20% AS and 20% AC lotions in their axillae (one treatment per axilla) every night for 2 weeks; next, the application was reduced to three times a week for 4 weeks. The assessment was performed using the sweating intensity visual scale (SIVS), hyperhidrosis disease severity score (HDSS), patient satisfaction score, and the appearance of adverse effects on weeks 0, 1, 2, 4, 6, and 8. Both AS as well as AC application showed positive results, significantly differing from the baseline, as assessed using SIVS, HDSS, and patient satisfaction score at every follow-up visit; however, no significant difference was observed between the AS and AC groups at any follow-up visit. The mean time of response was 1.14 weeks for both treatments. A side effect was observed in one subject (5%), who reported itching on the AC axilla. The therapeutic effects persisted even after reducing the frequency of application and lasted for at least two weeks after cessation of use. In conclusion, topical 20% AS demonstrated similar efficacy to topical 20% AC in the treatment of primary axillary hyperhidrosis, with a high safety profile. This article is protected by copyright. All rights reserved.
PMID: 32990370 [PubMed – as supplied by publisher]
Treatment Patterns, Depression, and Anxiety Among US Patients Diagnosed with Hyperhidrosis: A Retrospective Cohort Study.
Treatment Patterns, Depression, and Anxiety Among US Patients Diagnosed with Hyperhidrosis: A Retrospective Cohort Study.
Dermatol Ther (Heidelb). 2020 Sep 11;:
Authors: Klein SZ, Hull M, Gillard KK, Peterson-Brandt J
Abstract
INTRODUCTION: Hyperhidrosis is associated with social and emotional stress due to limitations on health-related quality of life. This study examined real-world treatment patterns and concomitant depression and/or anxiety in patients with hyperhidrosis.
METHODS: Commercial health plan members in the US with ≥ 2 hyperhidrosis diagnosis codes and/or antiperspirant prescription claims were identified from January 2010 through November 2017. A control cohort (CC) of patients without hyperhidrosis was matched to the hyperhidrosis cohort on demographic characteristics. Depression and/or anxiety were identified by ≥ 1 relevant diagnosis code or pharmacy claim. A multivariable logistic regression model estimated odds of treatment in the hyperhidrosis cohort, and depression/anxiety in the hyperhidrosis cohort and CC, adjusting for patient characteristics.
RESULTS: A total of 44,484 patients with hyperhidrosis were identified, of whom 58.5% were female, with a mean (± standard deviation) age of 36.5 ± 16.5 years (83.5% ≥ 18 years). A small majority of patients (51.6%, 0.69/person-year) received treatment with prescription antiperspirants. Post-index oral systemic therapies, medical procedures, and surgical options were uncommon. At 12 months post-index, 48.4% of the sample had not filled a prescription for extra- or prescription-strength antiperspirants. Compared with the CC (n = 137,451), a higher percentage of patients with hyperhidrosis had depression or anxiety reported during follow-up (41.1 vs. 28.2%, p < 0.001); this corresponded to higher adjusted odds of depression/anxiety in patients with hyperhidrosis [odds ratio (OR) 1.76, 95% confidence interval (CI) 1.72-1.80, p < 0.001]. Baseline depression and/or anxiety were associated with lower odds of receiving hyperhidrosis treatment (OR 0.77, 95% CI 0.73-0.80), as was increasing age and male gender. Patients with hyperhidrosis also had more frequent incident depression/anxiety during follow-up (18.2 vs. 10.6%, p < 0.001).
CONCLUSION: In this real-world analysis, hyperhidrosis was associated with increased odds of depression and/or anxiety. However, relatively low percentages of patients received prescription topical or oral treatments or underwent surgery, suggesting that tolerability, efficacy, and provider awareness may be limiting factors in the effective treatment of hyperhidrosis.
PMID: 32915394 [PubMed – as supplied by publisher]
Pharmacologic anisocoria secondary to topical glycopyrronium for axillary hyperhidrosis: an emerging clinical presentation.
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Pharmacologic anisocoria secondary to topical glycopyrronium for axillary hyperhidrosis: an emerging clinical presentation.
Can J Ophthalmol. 2020 Jul 28;:
Authors: Kaufman AR, Gulati S, Curnyn KM
PMID: 32735775 [PubMed – as supplied by publisher]
Stepwise treatment of primary focal hyperhidrosis with aluminium chloride hexahydrate lotion (20%) and oral glycopyrrolate: a retrospective study from a tertiary care centre
Abstract
Background
Primary focal hyperhidrosis is a common reason for dermatology outpatient visit and has significant impact on patient’s social and professional activities. The study describes the clinical profile of those patients and response with aluminum chloride hexahydrate lotion (ACH 20%) and oral glycopyrrolate (OGP).
Methods
A retrospective study was carried out at a tertiary care centre between the year 2016‐18. Details of history, baseline assessment, treatment response recorded in specially designed proformas were analysed. Initially the patients received topical ACH daily at night. Non‐responders were advised OGP 1 mg BD and increased to 2 mg BD if they didn’t respond. Response was measured according to patient global assessment and objective evaluation of sweating.
Results
Among total 69 patients 57 had onset