Oxybutynin 3% gel for the treatment of primary focal hyperhidrosis in adolescents and young adults

Nguyen, N.; Gralla, Jane; Abbott, Jeff; Bruckner, Anna L.

doi:10.1111/pde.13404

Cited by 22 publications

(26 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A recent publication summarized favorable results on hyperhidrosis severity and quality of life in adolescents/young adults with topical administration of the anticholinergic oxybutynin, though this was a small (N = 10), uncontrolled pilot study . The unmet need for new therapies may be addressed with GT, which in this analysis mitigated disease severity while improving quality of life in pediatric patients, with a favorable safety profile.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials

Hebert

Glaser

Green

et al. 2018

Pediatric Dermatology

View full text Add to dashboard Cite

Objectives Hyperhidrosis in pediatric patients has been understudied. Post hoc analyses of two phase 3 randomized, vehicle‐controlled, 4‐week trials (ATMOS‐1 [NCT02530281] and ATMOS‐2 [NCT02530294]) were performed to assess efficacy and safety of topical anticholinergic glycopyrronium tosylate (GT) in pediatric patients. Methods Patients had primary axillary hyperhidrosis ≥ 6 months, average Axillary Sweating Daily Diary (ASDD/ASDD‐Children [ASDD‐C]) Item 2 (sweating severity) score ≥ 4, sweat production ≥ 50 mg/5 min (each axilla), and Hyperhidrosis Disease Severity Scale (HDSS) ≥ 3. Coprimary end points were ≥ 4‐point improvement on ASDD/ASDD‐C Item 2 (a validated patient‐reported outcome) and change in gravimetrically measured sweat production at Week 4. Efficacy and safety data are shown through Week 4 for the pediatric (≥ 9 to ≤ 16 years) vs older (> 16 years) subgroups. Results Six hundred and ninety‐seven patients were randomized in ATMOS‐1/ATMOS‐2 (GT, N = 463; vehicle, N = 234); 44 were ≥ 9 to ≤ 16 years (GT, n = 25; vehicle, n = 19). Baseline disease characteristics were generally similar across subgroups. GT‐treated pediatric vs older patients had comparable improvements in ASDD/ASDD‐C Item 2 (sweating severity) responder rate, HDSS responder rate (≥ 2‐grade improvement]), sweat production, and quality of life (mean change from Baseline in Dermatology Life Quality Index [DLQI]/children's DLQI), with greater improvement vs vehicle. Treatment‐emergent adverse events were similar between subgroups, and most were mild, transient, and infrequently led to discontinuation. Conclusions Topical, once‐daily GT improved disease severity (ASDD/ASDD‐C, HDSS), sweat production, and quality of life (DLQI), with similar findings in children, adults, and the pooled population. GT was well tolerated, and treatment‐emergent adverse events were qualitatively similar between subgroups and consistent with other anticholinergics.

show abstract

Section: Discussionmentioning

confidence: 99%

“…30,31 A recent publication summarized favorable results on hyperhidrosis severity and quality of life in adolescents/young adults with topical administration of the anticholinergic oxybutynin, though this was a small (N = 10), uncontrolled pilot study. 32…”

Section: Discussionmentioning

confidence: 99%

Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials

Hebert

Glaser

Green

et al. 2018

Pediatric Dermatology

View full text Add to dashboard Cite

show abstract

mentioning

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.…”

mentioning

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

View full text Add to dashboard Cite

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.

show abstract

“…[ 147 ] In a small pilot study (NCT02633371) with patients aged 13‐24 years, a 3% oxybutynin gel was applied topically and hyperhidrosis severity was reduced while adverse events were mostly mild‐to‐moderate. [ 148 ] A fixed dose combination of oxybutynin and pilocarpine, an agonist‐antagonist combination (called THVD‐102), has been assessed in patients with axillary and/or palmar hyperhidrosis. Efficacy and safety of the combination therapy were comparable to oxybutynin alone, but the incidence of dry mouth, the most common side effect of anticholinergics, was significantly reduced compared to oxybutynin monotherapy.…”

Section: Modulators Of the Cholinergic Systemmentioning

confidence: 99%

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

Soeberdt

Kilić

Abels

2020

Experimental Dermatology

View full text Add to dashboard Cite

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.

show abstract

Oxybutynin 3% gel for the treatment of primary focal hyperhidrosis in adolescents and young adults

Abstract: Oxybutynin 3% gel reduced hyperhidrosis severity and improved health-related quality of life in this small pilot study. Safety and efficacy should be further evaluated in a large, prospective, placebo-controlled study.

Cited by 22 publications

References 8 publications

Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials

Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials

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

Contact Info

Product

Resources

About