Category: Axillary

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Rib-oriented Thoracoscopic Sympathetic Surgery for Hyperhidrosis: Prospective Long-term Results and Quality of Life.

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Rib-oriented Thoracoscopic Sympathetic Surgery for Hyperhidrosis: Prospective Long-term Results and Quality of Life.

Surg Laparosc Endosc Percutan Tech. 2021 Feb 16;:

Authors: Nachira D, Meacci E, Congedo MT, Petracca-Ciavarella L, Zanfrini E, Iaffaldano A, Vita ML, Chiappetta M, Griffo R, Lococo F, Margaritora S

Abstract
BACKGROUND: The optimal thoracoscopic sympathetic surgery for primary palmar and/or axillary hyperhidrosis (PPAH) is still unclear because of lack of uniform technique and qualitative/quantitative scales for definition of results. The aims of this study were to compare long-term outcomes based on the surgical technique and the level of sympathetic trunk interruption by clipping and to assess postoperative compensatory sweating (CS), patients’ satisfaction, and quality of life (QoL).
MATERIALS AND METHODS: Between September 2009 and April 2016, 94 patients who underwent 2-stage bilateral thoracoscopic rib-oriented (R) sympathetic clipping were prospectively followed up through the administration of standardized preoperative and postoperative questionnaires.Thirty-four (36.2%) patients underwent single-port transaxillary access instead of the standard two 5-mm incisions. The level of sympathetic clipping for PPAH was R3+4(top and bottom); in patients who complained associated facial or plantar hyperhidrosis R2-bottom and R5-top were clipped, respectively. Seventy-five patients completed bilateral surgery.
RESULTS: There were no significant differences between single-port and biportal video-assisted thoracoscopic surgery in terms of operative times and postoperative results. At a mean follow-up of 72 (SD: 26) months, CS was reported in 42 (56%) patients, severe only in 6 (8%). It was higher in the case of R2-bottom clipping (P=0.03). Thirty-one of 60 (51.6%) patients who had a plantar hyperhidrosis declared an improvement of feet sweating after surgery. Postoperative satisfaction was excellent (86.11% on a 0 to 100 scale) and 95.4% of patients declared an improvement in QoL, which was statistically significant in all evaluated parameters. These results were not related to the level of clipping.
CONCLUSION: Thoracoscopic R3 to R4 clipping appears to be a safe and effective treatment for PPAH. Although postoperative CS was common and higher after R2-bottom clipping, this did not seem to affect patients’ satisfaction and improvement in QoL.

PMID: 33605681 [PubMed – as supplied by publisher]

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A systematic evidence-based review of treatments for primary hyperhidrosis.

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A systematic evidence-based review of treatments for primary hyperhidrosis.

J Drug Assess. 2020 Dec 24;10(1):35-50

Authors: Stuart ME, Strite SA, Gillard KK

Abstract
Objective: Hyperhidrosis (excessive sweating) is associated with significant quality-of-life burden yet is often undertreated. With limited FDA-approved treatments, health care providers must determine optimal treatment among approved and off-label options. Key objectives of this review were to reassess, update, and expand a previous systematic review of commonly used treatment options for primary hyperhidrosis, including consideration of aluminum and zirconium compounds.
Methods: We performed a qualitative systematic review of efficacy, health-related quality of life, satisfaction, and safety of interventions, replicating and expanding the strategy outlined in a previous systematic review, with the addition of studies utilizing a within-patient design. We performed a critical appraisal of identified studies to determine risk of bias (RoB) and strength of evidence (SOE).
Results: A total of 32 studies were eligible for critical appraisal. Only three studies – two clinical trials of glycopyrronium cloth (2.4%) and one trial of botulinum toxin A injections in axillary hyperhidrosis were rated as “low” RoB; both had SOE ratings of “moderate” for use in axillary hyperhidrosis – the highest rating included in this review.
Conclusions: Optimal treatment choice depends on several factors, including understanding the quality of evidence regarding each treatment’s efficacy and safety (considerations of convenience and cost are beyond the scope of this review). In hyperhidrosis, as in other clinical conditions, treatment decisions should be patient centered. At this time, because of the quality of evidence, only imprecise estimates of effect are possible for hyperhidrosis treatments included in this review, and statements about comparative effectiveness are not possible.

PMID: 33489435 [PubMed]

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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]