Category: Axillary

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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]

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A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis.

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A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis.

J Dermatol. 2021 Jan 07;:

Authors: Yokozeki H, Fujimoto T, Abe Y, Igarashi M, Ishikoh A, Omi T, Kanda H, Kitahara H, Kinoshita M, Nakasu I, Hattori N, Horiuchi Y, Maruyama R, Mizutani H, Murakami Y, Watanabe C, Kume A, Hanafusa T, Hamaguchi M, Yoshioka A, Egami Y, Matsuo K, Matsuda T, Akamatsu M, Yorozuya T, Takayama S

Abstract
A phase 3 study was conducted to verify the efficacy and safety of 5% sofpironium bromide (BBI-4000) gel (hereinafter referred to as sofpironium) administrated for 6 weeks in Japanese patients with primary axillary hyperhidrosis. The primary efficacy end-point was the proportion of patients who satisfied both criteria of a Hyperhidrosis Disease Severity Score (HDSS) of 1 or 2 at the end of 6-week treatment and a 50% or more reduction in total gravimetric weight of sweat at the end of treatment relative to baseline. A total of 281 patients were randomized to receive 5% sofpironium (141 patients) or vehicle (140 patients), and all patients were included in the full analysis set (FAS). In the FAS, 70.1% of patients were female, and the median age was 35.0 years. The proportion of patients who achieved the primary efficacy end-point was 53.9% in the sofpironium group and 36.4% in the vehicle group, with a statistically significant difference of 17.5% (95% confidence interval, 6.02-28.93) between these two groups (P = 0.003). The incidence of adverse events was 44.0% in the sofpironium group and 30.7% in the vehicle group, and the incidence of adverse drug reactions was 16.3% in the sofpironium group and 5.0% in the vehicle group. Reported adverse events were generally mild or moderate in severity. In the sofpironium group, common events (incidence, ≥5%) were nasopharyngitis (14.2%) and dermatitis/erythema at the application site (8.5%/5.7%), with no serious adverse events reported. This study demonstrated the efficacy and safety of 5% sofpironium.

PMID: 33410265 [PubMed – as supplied by publisher]

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[Hyperhidrosis from diagnosis to management].

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[Hyperhidrosis from diagnosis to management].

Rev Med Interne. 2020 Nov 28;:

Authors: Aubignat M

Abstract
Hyperhidrosis is defined as uncontrollable, excessive and unpredictable sweating that exceeds the needs related to thermoregulation. It preferentially affects axillary, palms, soles and face but can affect any part of the body. This ostensibly benign symptom can have a major negative impact on quality of life sometimes leading to isolation and depression. Moreover, in some cases hyperhidrosis can be secondary to an underlying pathology sometimes malignant which must be identified quickly. Consequently, each doctor should be able to develop a diagnostic and therapeutic approach for this relatively frequent and probably underdiagnosed and undertreated reason for consultation. In this review, we focus on diagnosis hyperhidrosis and its management.

PMID: 33261887 [PubMed – as supplied by publisher]

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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]

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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.

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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]

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Oxybutynin in primary hyperhidrosis: a long-term real-life study.

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Oxybutynin in primary hyperhidrosis: a long-term real-life study.

Dermatol Ther. 2020 Sep 27;:e14344

Authors: Almeida ART, Ferrari F, Restrepo MVS, Rocha VB

Abstract
Hyperhidrosis is a condition of excessive sweating beyond physiological parameters that can seriously impair quality of life. This study aims to evaluate the oral oxybutynin effectiveness in hyperhidrosis, besides its tolerance and safety. In a real-life long-term study, thirty patients with primary hyperhidrosis and Hyperhidrosis Disease Severity Scale (HDSS) with score of at least two were submitted to a questionnaire to assess demographic data, HDSS and side effects of oxybutynin. Most patients were women (n = 23, 76.7%), median age was 40y (range 12-70, SD 17.5) and 17(56.7%) had family history of hyperhidrosis. The most common hyperhidrosis form was axillary (n = 15, 50.0%), followed by palmoplantar (n = 8, 26.7%), cranio-facial (n = 11, 36.7%) and trunk (n = 5, 16.7%). Median duration of treatment was 2.4y (range 1-6y, SD 1.3). Thus, all patients used oxybutynin for at least one year, 30% for two years, 20% three years, 17% four years and 3% six years. There was a significant improvement in HDSS score of patients (P < 0.001). This real life study suggests that oxybutynin is effective and safe for treatment of hyperhidrosis, both in children and adults, with mild and tolerable side effects, with significant improvement in HDSS. This article is protected by copyright. All rights reserved.

PMID: 32981151 [PubMed – as supplied by publisher]

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Diagnosis, impact and management of hyperhidrosis including endoscopic thoracic sympathectomy.

Diagnosis, impact and management of hyperhidrosis including endoscopic thoracic sympathectomy.

Med J Malaysia. 2020 Sep;75(5):555-560

Authors: Ho YL, Fauzi M, Sothee K, Basheer A

Abstract
INTRODUCTION: Hyperhidrosis is a disorder of excessive and uncontrollable sweating beyond the body’s physiological needs. It can be categorised into primary or secondary hyperhidrosis based on its aetiology. Detailed history review including onset of symptoms, laterality of disease and family history are crucial which may suggest primary hyperhidrosis. Secondary causes such as neurological diseases, endocrine disorders, haematological malignancies, neuroendocrine tumours and drugs should be adequately examined and investigated prior to deciding on further management. The diagnosis of primary hyperhidrosis should only be made only after excluding secondary causes. Hyperhidrosis is a troublesome disorder that often results in social, professional, and psychological distress in sufferers. It remains, however, a treatment dilemma among some healthcare providers in this region.
METHODS: The medical records and clinical outcomes of 35 patients who underwent endoscopic thoracic sympathectomy for primary hyperhidrosis from 2008 to 2018 in Department of Cardiothoracic Surgery were reviewed.
RESULTS: The mean age of the patients was 27±10.1years, with male and female distribution of 18 and 17, respectively. Fifty-one percent of patients complained of palmar hyperhidrosis, while 35% of them had concurrent palmaraxillary and 14% had palmar-plantar-axillary hyperhidrosis. Our data showed that 77% (n=27) of patients were not investigated for secondary causes of hyperhidrosis, and they were not counselled on the non-surgical therapies. All patients underwent single-staged bilateral endoscopic thoracic sympathectomy. There was resolution of symptoms in all 35 (100%) patients with palmar hyperhidrosis, 13(76%) patients with axillary hyperhidrosis and only 2 (50%) patients with plantar hyperhidrosis. Postoperatively 34.3% (n=12) of patients reported compensatory hyperhidrosis. There were no other complications such as pneumothorax, chylothorax, haemothorax and Horner’s Syndrome.
CONCLUSION: Clinical evaluation of hyperhidrosis in local context has not been well described, which may inadvertently result in the delay of appropriate management, causing significant social and emotional embarrassment and impair the quality of life of the subjects. Detailed clinical assessment and appropriate timely treatment, be it surgical or non-surgical therapies, are crucial in managing this uncommon yet distressing disease.

PMID: 32918426 [PubMed – as supplied by publisher]