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

Phase 4

Completed

• Conditions: Hyperhidrosis
• Interventions: Drug: Oxybutynin; Drug: placebo

• Registration Number: NCT01310712
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-02
• Status Verified: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-03-07
• Study First Posted: 2011-03-08
• Last Update Submitted: 2011-09-21
• Last Update Posted: 2011-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adult patients with hyperhidrosis

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Exclusion Criteria

• Glaucoma and pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oxybutynin	Oxybutynin	patients will receive in the end of the treatment, 10 mg of oxybutynin a day
Placebo	placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Improvement of Quality of life in patients with hyperhidrosis with the use of oxybutynin	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

Secondary Outcome Measures

Name	Time	Method
The use of oxybutynin diminishes hyperhidrosis	6 weeks	if the use of oxybutynin diminishes hyperhidrosis

Trial Locations

Locations (1)

Hospital das Clinicas da FMUSP; 🇧🇷 Sao Paulo, Brazil