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临床试验/NCT01310712
NCT01310712已完成4 期

Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study.

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Improvement of Quality of life in patients with hyperhidrosis with the use of oxybutynin

研究概览

简要总结

Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.

详细描述

Introduction

Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.

Purpose: The objective of this study is to evaluate the effectiveness and patient satisfaction with the use of oxybutynin at low doses comparing to placebo for treating palmar hyperhidrosis.

Methods: This is a prospective, randomized and controlled study. From December 2010 to february 2011, 50 consecutive patients with palmar hyperhidrosis were treated with oxybutynin or placebo. Data were collected from 50 patients, and 5 (10,0%) patients were lost to follow-up. During the first week, patients received 2.5 mg of oxybutynin once a day in the evening. From the 8th to the 42nd day, they received 2.5 mg twice a day, and from the 43rd day to the end of the 12th week, they received 5 mg twice a day. All of the patients underwent 2 evaluations: before and after (12 weeks) the oxybutynin treatment, using a clinical questionnaire; and a clinical protocol for quality of life (QOL).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with hyperhidrosis

排除标准

  • Glaucoma and pregnancy

研究组 & 干预措施

oxybutynin

Experimental

patients will receive in the end of the treatment, 10 mg of oxybutynin a day

干预措施: Oxybutynin (Drug)

Placebo

Placebo Comparator

Placebo

干预措施: placebo (Drug)

结局指标

主要结局

Improvement of Quality of life in patients with hyperhidrosis with the use of oxybutynin

时间窗: 6 weeks

Using a Quality of life protocol we will study if patients with hyperhidrosis using oxybutynin have an improvement in their quality of life

次要结局

  • The use of oxybutynin diminishes hyperhidrosis(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nelson Wolosker

MD, PhD

University of Sao Paulo

研究点 (1)

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