Comparison of patient-reported disease severity and sweat measurements in primary focal hyperhidrosis

Gibbons, Mitchell; Armbrecht, Eric S.; Dudzinski, Jacob; Glaser, Dee Anna

doi:10.1016/j.jaad.2019.04.015

Cited by 5 publications

(7 citation statements)

References 3 publications

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“…Furthermore, in a phase III study with SB 5%, the proportion of patients whose HDSS was improved to a score of 1 or 2 at the EOT and with a > 50% reduction in gravimetrically assessed sweat production at the EOT was 53·9% (SB) vs. 36·4% (placebo) 33 . Only minor positive trends between gravimetry and HDSS scores were found in primary focal HH 37 . The poor correlation may be due to the combination of distinct concepts of tolerability and interference with daily activities in a single, patient self‐reported rating question 36,38 .…”

Section: Discussionmentioning

confidence: 97%

“…33 Only minor positive trends between gravimetry and HDSS scores were found in primary focal HH. 37 The poor correlation may be due to the combination of distinct concepts of tolerability and interference with daily activities in a single, patient self‐reported rating question. 36 , 38 Despite being disease‐specific, validated and frequently used, the HDSS could be flawed in its interpretation.…”

Section: Discussionmentioning

confidence: 99%

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A glycopyrronium bromide 1% cream for topical treatment of primary axillary hyperhidrosis: efficacy and safety results from a phase IIIa randomized controlled trial*

et al. 2021

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Summary Background Effective topical treatment options for patients with primary axillary hyperhidrosis (PAHH) are limited. A phase I trial showed promising results regarding the efficacy and safety of a topical cream containing glycopyrronium bromide (GPB). Objectives To assess the efficacy, safety and tolerability of a 4‐week topical treatment of GPB 1% cream in patients with PAHH vs. placebo. Methods In total, 171 patients (84 receiving placebo; 87 receiving GPB 1%) with PAHH were included in the 4‐week, multicentre, randomized, double‐blind, placebo‐controlled phase IIIa part of the pivotal study. Sweat production was measured by gravimetry. Patients rated the impact of disease with 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 GPB 1% group compared with the placebo group (P = 0·004). The improvement in HidroQoL exceeded the minimal clinically important difference of 4. The proportion of responders was twofold higher for sweat reduction (–197·08 mg GPB 1% vs. –83·49 mg placebo), HDSS (23% GPB 1% vs. 12% placebo) and HidroQoL (60% GPB 1% vs. 26% placebo). Treatment was safe: most treatment‐emergent adverse effects were mild or moderate, and transient. Local tolerability was very good, with 9% of patients having only mild or moderate application‐site reactions. The most reported adverse drug reaction was dry mouth (16%), an expected anticholinergic effect of the treatment. Conclusions GPB 1% cream may provide an effective new treatment option exhibiting a good safety profile for patients with PAHH. The long‐term open‐label part (phase IIIb) is ongoing.

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Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

A glycopyrronium bromide 1% cream for topical treatment of primary axillary hyperhidrosis: efficacy and safety results from a phase IIIa randomized controlled trial*

et al. 2021

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“…This large variation in GSP is not surprising, because many factors influence GSP including diet, emotions, environmental conditions, and medication use, 19 and it has been suggested that GSP is not a good indicator of hyperhidrosis disease severity. 20,21 The data from this study emphasize the need for multiple assessments to confirm treatment effect. 19…”

Section: Discussionmentioning

confidence: 81%

A Pilot Study of the Safety and Effectiveness of a Novel Device in Subjects With Axillary Hyperhidrosis

et al. 2022

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“…In one study, it was found that you needed at least 23 patients pooled to observe a significant difference when measuring the effect of treatment 7 . In another study (the only other study of sufficient quality), it was observed that a single low gravimetric value was not necessarily indicative of a less severe disease 8 . Gravimetry captures a single 5‐minute snapshot which might fail to capture the full disease burden.…”

Section: Resultsmentioning

confidence: 99%

“…7 In another study (the only other study of sufficient quality), it was observed that a single low gravimetric value was not necessarily indicative of a less severe disease. 8 Gravimetry captures a single 5-minute snapshot which might fail to capture the full disease burden. The method can still be used to show differences between two groups receiving different treatments but not in the single patient.…”

Section: Diagnosticsmentioning

confidence: 99%

Progress and lack of progress in hyperhidrosis research 2015–2020. A concise systematic review

Kristensen¹,

Nielsen²

2021

Int J Dermatology

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Hyperhidrosis is excessive sweating that is uncontrollable and occurring regardless of temperature. Quality of life is significantly impaired, and psychiatric comorbidity is common.The objective of the study is to undertake a systematic review of research in the last 5 years regarding hyperhidrosis. Five databases were searched from July 2015 to July 2020 for all research on hyperhidrosis. High-quality research articles were sought for progress in diagnosis, etiology and epidemiology, and use of patient reported outcomes (PROs) as well as randomized clinical trials (RCTs) on any treatment intervention.Outcomes of interest were disease severity, sweat rate, quality of life, patient satisfaction, and adverse events. Trial quality was assessed by the Cochrane risk-of-bias tool. A narrative synthesis was presented. Twenty-nine papers were included in the review: 13 investigational articles, 10 RCTs, three cohort studies, and three reviews. The studies varied in terms of quality, population, intervention, and methods of outcome assessment. The majority were very small studies, and most RCTs were at high risk of bias. Few studies on diagnosis, epidemiology, and etiology were of sufficient quality to be presented.The interventions discussed were iontophoresis, botulinum toxin, anticholinergic medication, curettage, and energy-based technologies. Progress in the diagnostics and etiology of hyperhidrosis is limited with the same being true for treatment. In a 5-year-old systematic review, it was concluded that there was moderate-quality evidence to support the use of botulinum toxin for axillary hyperhidrosis. It was advocated to conduct a trial comparing BTX and iontophoresis for palmar hyperhidrosis. Unfortunately, this has not yet been performed. Hyperhidrosis is still as underserved and under-studied as before.

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Comparison of patient-reported disease severity and sweat measurements in primary focal hyperhidrosis

Cited by 5 publications

References 3 publications

A glycopyrronium bromide 1% cream for topical treatment of primary axillary hyperhidrosis: efficacy and safety results from a phase IIIa randomized controlled trial*

A glycopyrronium bromide 1% cream for topical treatment of primary axillary hyperhidrosis: efficacy and safety results from a phase IIIa randomized controlled trial*

A Pilot Study of the Safety and Effectiveness of a Novel Device in Subjects With Axillary Hyperhidrosis

Progress and lack of progress in hyperhidrosis research 2015–2020. A concise systematic review

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