Category: Axillary

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Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax): Evaluation of Measurement Performance

J Drugs Dermatol. 2021 Apr 1;20(4):410-418. doi: 10.36849/JDD.2021.5569.

ABSTRACT

BACKGROUND: Clinical trials of primary axillary hyperhidrosis (AHH) require rigorous measurement of AHH severity from the patient’s perspective. Previously, we reported conceptualization and item content development for the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale.

OBJECTIVE: To evaluate the psychometric performance and estimate clinically meaningful change scores for the HDSM-Ax in a Phase IIb clinical study of sofpironium bromide gel for AHH.

METHOD: HDSM-Ax measurement performance was analyzed in trial response data using two psychometric paradigms: Classical Test and Rasch Measurement Theories (CTT; RMT). HDSM-Ax meaningful change scores were estimated from anchor-based methods using two global summary questions of hyperhidrosis severity and the Hyperhidrosis Disease Severity Score (HDSS).

RESULTS: HDSM-Ax satisfied CTT and RMT criteria as a fit-for-purpose outcome measure in AHH clinical trials. Within-person anchor-based analyses indicated a 1-point change in HDSM-Ax severity score (range, 0–4) represents a clinically meaningful change in AHH severity.

CONCLUSION: HDSM-Ax is a well-defined and reliable measure of AHH severity. A 1-point change in HDSM-Ax score is clinically meaningful. J Drugs Dermatol.20(4):410-418. doi:10.36849/JDD.5569.

PMID:33852243 | DOI:10.36849/JDD.2021.5569

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Bilateral one-stage single-port sympathicotomy in primary focal hyperhidrosis, a prospective cohort study: treat earlier?

J Cardiothorac Surg. 2021 Mar 25;16(1):50. doi: 10.1186/s13019-021-01430-0.

ABSTRACT

BACKGROUND: Primary Focal Hyperhidrosis (PFH) has a detrimental effect on Quality of Life. Repetitive, non-curative symptomatic strategies dominate current treatment of PFH, in spite of the availability of an effective and permanent curative treatment like Endoscopic Thoracic Sympathectomy (ETS). Current surgical optimization may allow for a re-established position of sympathetic modulation in this treatment algorithm. We sought to evaluate the safety, effectiveness, and long-term results of a Bilateral One-stage Single-port Sympathicotomy (BOSS) procedure in PFH patients and to identify subgroups benefitting most.

METHODS: Prospective analysis of 163 patients, 35 (21.5%) underwent Rib-3 (R3) BOSS for palmar PFH, 58 (35.6%) R3-R5 BOSS for axillary PFH and 70 (42.9%) R3-R5 BOSS for combined palmar/axillary PFH. Effectiveness was measured using Skindex-29 and the Hyperhidrosis Disease Severity Scale (HDSS).

RESULTS: Overall Skindex-29-rating (46.5 ± 14.8 preoperatively vs 20.1 ± 20.6 postoperatively, p < 0.001), and HDSS score (3.71 ± 0.45 preoperatively vs 1.82 ± 0.86 postoperatively, p < 0.001) indicated a significant improvement in health-related quality of life after BOSS. R3 BOSS was superior to R3-R5 BOSS in terms of HDSS score (1.49 vs 1.91 respectively, p = 0.004) and in terms of severe compensatory hyperhidrosis, a frequently reported side-effect (17.1% vs 32.8% respectively, p < 0.001). No major complications occurred.

CONCLUSIONS: BOSS is safe, effective, and offers a long-term curative solution in the treatment of PFH. Especially in the palmar PFH subgroup, R3 BOSS treatment results compare favorably to the treatment results of non-curative alternatives published in the current literature. Therefore, R3 BOSS should be offered to all patients with severe PFH, reporting insufficient benefit of treatment options such as oral and/or local agents.

PMID:33766091 | DOI:10.1186/s13019-021-01430-0

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Effects of lower thoracic sympathicotomy on plantar hyperhidrosis

J Thorac Dis. 2021 Feb;13(2):664-670. doi: 10.21037/jtd-20-2437.

ABSTRACT

BACKGROUND: The purpose of this study was to investigate whether performing lower thoracic sympathicotomy (LTS) from T10 to T12 affects plantar hyperhidrosis in patients with palmo-plantar (PP) or palmo-axillary-plantar (PAP) hyperhidrosis.

METHODS: Between January 2015 and January 2020, all consecutive patients with primary hyperhidrosis who underwent bilateral thoracoscopic sympathicotomy and met the inclusion criteria were included. Sympathicotomy was performed using one of the following two methods: the conventional upper thoracic vs. expanded thoracic sympathicotomy. In the expanded thoracic sympathicotomy, we expanded the level of sympathicotomy ranging from R5 to R12 in addition to the conventional upper thoracic sympathicotomy (R3 or R4). In cases of the expanded thoracic sympathicotomy, we defined the LTS as a sympathicotomy of the levels ranging from R10 to R12, which are related to plantar hyperhidrosis.

RESULTS: A total of 103 subjects with PP (71 cases) or PAP (32 cases) hyperhidrosis were included. Palmar or axillary hyperhidrosis in all patients were alleviated after sympathicotomy. There was no difference in sweating decrease or CH according to the hyperhidrosis types or sympathicotomy techniques. In addition, no-LTS was performed in 77 cases and LTS was performed in 26 cases. In the no-LTS group, there were 65 and 12 cases of low and high degrees of CH, respectively. In the LTS group, there were 22 and four cases of low and high degrees of CH, respectively. There was no significant difference in CH between the no-LTS and LTS groups (P=0.981). Improvement in plantar hyperhidrosis in the no-LTS group was observed in 29 of 77 cases, while improvement in plantar hyperhidrosis in the LTS group was observed in 16 of 26 cases. The addition of LTS lead to significant improvement in plantar hyperhidrosis (P=0.034).

CONCLUSIONS: Performing LTS is a safe and feasible procedure that improved plantar sweating more so than it did in cases that did not undergo LTS. Therefore, we cautiously suggest that adding LTS helps in the treatment of plantar hyperhidrosis combined with palmar hyperhidrosis. Further studies on LTS are needed to validate these findings and will be helpful in establishing management guidelines.

PMID:33717539 | PMC:PMC7947522 | DOI:10.21037/jtd-20-2437

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A case series evaluating microwave-based therapy for axillary hyperhidrosis and bromhidrosis

J Dermatolog Treat. 2021 Feb 23:1-4. doi: 10.1080/09546634.2020.1856317. Online ahead of print.

ABSTRACT

INTRODUCTION: Axillary hyperhidrosis and bromhidrosis have serious social, emotional, and professional consequences. There are several treatments of axillary hyperhidrosis. We present a case series evaluating the efficacy and safety of microwave device for axillary hyperhidrosis and bromhidrosis.

MATERIALS AND METHODS: Seven patients were included in our case series. Four patients had both hyperhidrosis and bromhidrosis. Three patients had only hyperhidrosis. To evaluate the degree of hyperhidrosis and degree bromhidrosis a self-reported Hyperhidrosis Disease Severity Scale (HDSS) score and 4-point malodor grade were assessed. All patients underwent 1 or 2 microwave treatments. Patients underwent a survey on treatment outcomes and adverse effect conducted through telephone 12 months after their last procedure.

RESULTS: Six of seven patients had a 2-point drop in HDSS score. The four patients with bromhidrosis had a 2-point drop on the self-reported malodor measurement 12 months post treatment. Minor adverse effects related to the therapy occurred.

CONCLUSION: This novel microwave-based treatment was effective for the treatment of axillary hyperhidrosis and bromhidrosis. Patient satisfaction with the procedure is high, and adverse events are typically transient and well tolerated.

PMID:33622150 | DOI:10.1080/09546634.2020.1856317

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Botulinum Toxin Versus Placebo: A Meta-Analysis of Treatment and Quality-of-life Outcomes for Hyperhidrosis

Aesthetic Plast Surg. 2021 Feb 22. doi: 10.1007/s00266-021-02140-7. Online ahead of print.

ABSTRACT

AIMS: This study aims at assessing the treatment effect, disease severity and quality-of-life outcomes of botulinum toxin (BTX) injections for focal hyperhidrosis.

METHODS: We included randomized controlled trials of BTX injections compared with placebo for patients with primary or secondary focal hyperhidrosis. PubMed, Embase and the Cochrane Library were searched to August 2020. Gravimetric sweat rate reduction, disease severity measured by Hyperhidrosis Disease Severity Scale and quality-of-life assessment measured by Dermatology Life Quality Index were the outcomes of interest. Cochrane risk-of-bias tools were employed for quality assessment of given randomized controlled trials.

RESULTS: Eight studies met our inclusion criteria (n=937). Overall, risk bias was mixed and mostly moderate. BTX injections showed reduced risk in comparison with placebo for the gravimetric quantitative sweat reduction of > 50 % from baseline (risk difference: 0.63, 95% CI 0.51 to 0.74). Additionally, improvements were seen for disease severity and quality-of-life assessments evaluated by Hyperhidrosis Disease Severity Score reduction of ≥ 2 points (risk difference: 0.56, 95% CI 0.42 to 0.69) and mean change in Dermatology Life Quality Index (mean difference: – 5.55, 95% CI – 7.11 to – 3.98). The acquired data were insufficient to assess for long-term outcomes and limited to an eight-week follow-up period.

CONCLUSIONS: In focal axillary hyperhidrosis, BTX significantly reduces sweat production and yields superior outcomes in assessments of disease severity and quality-of-life. However, the quality-of-evidence is overall moderate and included studies account for short-term trial periods only. Further studies assessing BTX in comparison with first-line treatments for hyperhidrosis are warranted.

LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

PMID:33619611 | DOI:10.1007/s00266-021-02140-7

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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]