Safety and efficacy of topical formulations containing 0·5, 1 and 2% glycopyrronium bromide in patients with primary axillary hyperhidrosis: a randomized, double‐blind, placebo‐controlled study

Masur, Clarissa; Soeberdt, Michael; Kilić, Ana; Knie, Ulrich; Abels, Christoph

doi:10.1111/bjd.18234

Cited by 10 publications

(22 citation statements)

References 4 publications

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“…It is the most frequently used PROM in randomized controlled trials (RCTs) in dermatology. In addition, gravimetric sweat production was measured in milligrams for a duration of 5 min according to an internal standard operating procedure/manual and as already performed in the previous trial 14 . Data of the HidroQoL and the HDSS were collected at all four timepoints [days –7 to –4 (screening), day 1 (baseline), day 15 and day 29], DLQI data were collected from day 1 to day 29 and gravimetric sweat production was assessed at screening, baseline and day 29 (Figure 2).…”

Section: Methodsmentioning

confidence: 99%

“…Patients with severe primary axillary hyperhidrosis were asked to complete the HidroQoL four times during the phase III randomized placebo‐controlled part of a clinical trial investigating the effects of a topical cream containing 1% glycopyrronium bromide. The safety and efficacy of this topical cream was reported recently 14 . The study was registered (ClinicalTrials.gov identifier: NCT03658616) and ethical approval was given by the corresponding ethics committees of the different countries.…”

Section: Methodsmentioning

confidence: 99%

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Hyperhidrosis Quality of Life Index (HidroQoL©): further validation and clinical application in patients with axillary hyperhidrosis using data from a phase III randomized controlled trial*

et al. 2020

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Summary Background The Hyperhidrosis Quality of Life Index (HidroQoL©) is a validated patient‐reported outcome measure capturing the quality of life of people affected by hyperhidrosis. Objectives We aimed to extend the validity evidence to physician‐confirmed diagnosis of primary axillary hyperhidrosis. Methods Data from a phase III randomized placebo‐controlled clinical trial were used (n = 171). Confirmatory factor analysis was carried out to confirm the a priori two‐factor structure of the HidroQoL. Internal consistency was assessed using Cronbach’s α. Intraclass correlation coefficients (ICCs) were calculated to evaluate test–retest reliability after days –7 to –4. Convergent validity was assessed using correlations with the Dermatology Life Quality Index (DLQI), the Hyperhidrosis Disease Severity Scale (HDSS) and gravimetric sweat production. Known groups were analysed to evaluate discriminative validity. Responsiveness after 29 days was assessed and minimal important difference (MID) values were calculated using both anchor‐ and distribution‐based approaches. All analyses were carried out for total HidroQoL and its two domains. Results The two‐factor structure of the HidroQoL was confirmed. Internal consistency and test–retest reliability were strong (Cronbach’s α 0·81–0·90; ICCs 0·89–0·93). Correlations with other outcome measures were in line with a priori hypotheses. The HidroQoL discriminated between different severity groups (P ≤ 0·001) and showed sensitivity to change towards improvement (P < 0·001). An MID value of 4 is proposed for the total scale. Conclusions This study supports excellent measurement properties including clinical applicability of the HidroQoL in primary axillary hyperhidrosis and suggests a MID of 4 be applied to clinical trial data.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Hyperhidrosis Quality of Life Index (HidroQoL©): further validation and clinical application in patients with axillary hyperhidrosis using data from a phase III randomized controlled trial*

et al. 2020

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Section: Discussionmentioning

confidence: 99%

“…[90,91] Anticholinergic glycopyrronium used for treating various conditions (peptic ulcers, excessive salivation and COPD [155] ) was recently found to be effective and safe in the treatment of axillary hyperhidrosis. [180][181][182][183][184] The serotonin reuptake inhibitor fluoxetine, a compound showing very diverse activity and approved antidepressant, shows promising results as an agent to treat contact hypersensitivity reactions [215] and AD. [220] In conclusion, drug discovery in the field of dermato-endocrinology has progressed a lot in the last two decades, yielding a multitude of candidates which may lead to effective and safe treatment options for patients suffering from chronic inflammatory diseases of the skin or skin appendages.…”

Section: Summary and Con Clus I On Smentioning

confidence: 99%

“…The 1% and 2% glycopyrrolate creams showed clear reductions in symptom severity and adverse events were mild‐to‐moderate for all formulations. [ 180 ] Based on these results, the 1% cream was selected for further clinical development and a phase III trial (NCT03658616) to confirm the initial results is currently ongoing.…”

Section: Modulators Of the Cholinergic Systemmentioning

confidence: 99%

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Current and emerging treatments targeting the neuroendocrine system for disorders of the skin and its appendages

Soeberdt

Kilić

Abels

2020

Experimental Dermatology

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The skin as a neuroendocrine organ and the role of neuroendocrine signalling in the development of disorders affecting the skin and its appendages has received increasing attention in the last years. Different neuroendocrine systems have been described in the barrier organ skin, including the thyroid system, the hypothalamicpituitary-adrenal axis, the opioid, the endocannabinoid, the cholinergic, the secosteroidogenic and the serotonergic systems. All of these systems have been implicated in the development of skin diseases, which often have an inflammatory origin. These discoveries have led to an increase in the development of new drugs targeting components of neuroendocrine signalling pathways. Additionally, attempts have been made to repurpose already approved drugs targeting neuroendocrine signalling pathways in other organs for the treatment of skin diseases. Recently published results from preclinical and clinical studies look promising and may offer improved therapies to patients suffering from skin diseases in the near future. In this review, from a pharmaceutical point of view, we focus on recent progress in synthetic drug development of compounds targeting neuroendocrine signalling in the skin and its appendages to treat skin diseases such as atopic dermatitis, psoriasis, acne, alopecia areata and hyperhidrosis.

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Neue Entwicklungen bei Topika

Wohlrab

2019

Hautarzt

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Safety and efficacy of topical formulations containing 0·5, 1 and 2% glycopyrronium bromide in patients with primary axillary hyperhidrosis: a randomized, double‐blind, placebo‐controlled study

Cited by 10 publications

References 4 publications

Hyperhidrosis Quality of Life Index (HidroQoL©): further validation and clinical application in patients with axillary hyperhidrosis using data from a phase III randomized controlled trial*

Hyperhidrosis Quality of Life Index (HidroQoL©): further validation and clinical application in patients with axillary hyperhidrosis using data from a phase III randomized controlled trial*

Current and emerging treatments targeting the neuroendocrine system for disorders of the skin and its appendages

Neue Entwicklungen bei Topika

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