Topical oxybutynin deodorant for axillary hyperhidrosis: a topic or a systemic effect? Rationale and design of the phase II today trial.

IF 0.8 Q4 PERIPHERAL VASCULAR DISEASE
Jornal Vascular Brasileiro Pub Date : 2025-02-21 eCollection Date: 2025-01-01 DOI:10.1590/1677-5449.202400982
Samantha Neves, Giuliano Giova Volpiani, Alexia Paganotti, Felipe Menegueti, Ricardo Sanchez Boix, Roberto Augusto Caffaro, Vanessa Prado Dos Santos, Eduardo Ramacciotti
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引用次数: 0

Abstract

Anticholinergics have been shown to enhance quality of life and reduce sweat in patients with hyperhidrosis. However, it remains unclear whether topical application specifically exerts local or systemic effects. This study's primary aim is to assess topical oxybutynin's impact on axillary hyperhidrosis. Twenty patients will be randomized into three groups. Group A will receive 2.5 mg of oral oxybutynin from day 1 to day 35 (on a variable frequency regimen). Group B will be administered a topical placebo for 35 days and Group C will receive a 10% oxybutynin topical spray, to be used twice daily for 35 days. The primary efficacy outcome will be the evaluation of the effectiveness of topical oxybutynin spray in treating hyperhidrosis. The TODAY trial will generate high-quality evidence on the effects of topical oxybutynin, assessing whether its impact is local or systemic in patients with axillary hyperhidrosis.

局部奥昔布宁除臭剂治疗腋下多汗症:是局部的还是全身性的?II期临床试验的基本原理和设计。
抗胆碱能药物已被证明可以提高多汗症患者的生活质量并减少出汗。然而,目前尚不清楚外用是否会产生局部或全身效应。本研究的主要目的是评估外用奥布宁对腋窝多汗症的影响。20名患者将被随机分为三组。A组从第1天到第35天接受2.5 mg口服奥施布宁(频率可变)。B组将给予局部安慰剂35天,C组将接受10%奥布宁局部喷雾剂,每天使用两次,持续35天。主要疗效结果将是评价局部奥布宁喷雾剂治疗多汗症的有效性。TODAY试验将产生高质量的证据,证明局部使用奥布宁的效果,评估其对腋窝多汗症患者的影响是局部的还是全身性的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Jornal Vascular Brasileiro
Jornal Vascular Brasileiro Medicine-Cardiology and Cardiovascular Medicine
CiteScore
1.20
自引率
0.00%
发文量
57
审稿时长
20 weeks
期刊介绍: The Jornal Vascular Brasileiro is editated and published quaterly to select and disseminate high-quality scientific contents concerning original research, novel surgical and diagnostic techniques, and clinical observations in the field of vascular surgery, angiology, and endovascular surgery. Its abbreviated title is J. Vasc. Bras., which should be used in bibliographies, footnotes and bibliographical references and strips.
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