A phase 2a randomized controlled study to evaluate the pharmacokinetic, safety, tolerability and clinical effect of topically applied Umeclidinium in subjects with primary axillary hyperhidrosis

Nasir, Adnan; Bissonnette, Robert; Maari, Catherine; DuBois, Janet; Dumitrescu, Teodora Pene; Haddad, Jonathan; Yamaguchi, Yuji; D’Alessandro, Michelle Carvalho de Oliveira

doi:10.1111/jdv.14651

Cited by 11 publications

(13 citation statements)

References 16 publications

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confidence: 99%

“…Oral use is associated with improvements in QoL and clinical symptoms but at the cost of considerable systemic adverse events 11,12 . Topical formulations containing oxybutynin, GP, umeclidinium or sofpironium have also been used successfully in the treatment of HH but have not yet been approved in the European Union 13–16 …”

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confidence: 99%

“…11,12 Topical formulations containing oxybutynin, GP, umeclidinium or sofpironium have also been used successfully in the treatment of HH but have not yet been approved in the European Union. [13][14][15][16] The safety and efficacy of topical formulations containing GP bromide (GPB) for the treatment of PAHH were investigated in a phase I clinical trial in 2020. 17 The results confirmed the concept of a locally applied, locally acting product with a low potential for systemic side-effects.…”

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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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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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“…However, no clear separation from vehicle was observed for efficacy parameters. [154] Glycopyrronium is a highly polar quaternary amine and therefore cannot cross the blood-brain barrier, accounting for the lower incidence of CNS side effects compared to other anticholinergics. [132,155] It is available for clinical use as different salts.…”

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confidence: 99%

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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“…In addition, topical preparation of GPB has aroused interest as a treatment option for PHH [38] , and 1% GPB cream has completed the phase IIIa study [39] . A dermal preparation of Umeclidinium (UMEC) ammonium bromide is also under way [40] .…”

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confidence: 99%

Topical anticholinergic medications for primary hyperhidrosis: A protocol for a systematic review and meta-analysis

Gao

Zhu

Liu

et al. 2022

Preprint

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IntroductionPrimary hyperhidrosis (PHH) is a chronic condition characterized by excessive sweating. Several topical anticholinergic agents have been developed, but the evidence for the efficacy and tolerability of changing medication pathways of anticholinergics for PHH is limited.Methods and analysisPubMed, the Cochrane Library, Embase, the Web of Science, and the Cochrane Central Register of Controlled Trials will be searched from inception to March 2022 for studies that may be eligible for inclusion. Randomized controlled trials (RCTs) of PHH treated by topical anticholinergic drugs will be included. The primary outcomes include severity of hyperhidrosis measured quantitatively, the Hyperhidrosis Disease Severity Scale (HDSS) score or the proportion of subjects with a minimum 2-grade improvement from baseline in HDSS, the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) score and Dermatology Life Quality Index (DLQI). The secondary outcomes focused on safety and tolerability. Study selection, data extraction and assessment of risk of bias will be performed by two investigators independently. Data synthesis will be performed with RevMan 5.4 software.Ethics and disseminationEthical approval will not be needed in this review due to no data are involved in patient’s information and privacy. The results will be published and diffused in a peer-reviewed journal or relative conferences.Strengths and limitations of this studyThis systematic review will be the first to evaluate the efficacy and safety of topical anticholinergic agents in the treatment of PHH.Different inclusion criteria between studies and different skin sites where drugs applied may lead to clinical heterogeneity, which will be explored in the subgroup analysis.This study will also focus on evaluating systemic and topical safety and tolerability of topical application of anticholinergics.

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A phase 2a randomized controlled study to evaluate the pharmacokinetic, safety, tolerability and clinical effect of topically applied Umeclidinium in subjects with primary axillary hyperhidrosis

Abstract: Background Hyperhidrosis is a common medical condition which can have a significant impact on quality of life. Ume-

Cited by 11 publications

References 16 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*

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

Topical anticholinergic medications for primary hyperhidrosis: A protocol for a systematic review and meta-analysis

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