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

Primary Purpose

Hyperhidrosis

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Oxybutynin
placebo
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis focused on measuring hyperhidrosis, oxybutynin

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult patients with hyperhidrosis

Exclusion Criteria:

  • Glaucoma and pregnancy

Sites / Locations

  • Hospital das Clinicas da FMUSP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

oxybutynin

Placebo

Arm Description

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

Placebo

Outcomes

Primary Outcome Measures

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

The use of oxybutynin diminishes hyperhidrosis
if the use of oxybutynin diminishes hyperhidrosis

Full Information

First Posted
March 7, 2011
Last Updated
September 21, 2011
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01310712
Brief Title
Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study
Official Title
Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis
Keywords
hyperhidrosis, oxybutynin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oxybutynin
Arm Type
Experimental
Arm Description
patients will receive in the end of the treatment, 10 mg of oxybutynin a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Oxybutynin
Intervention Description
5 mg every 12 hours for 6 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo twice a day for 42 days.
Primary Outcome Measure Information:
Title
Improvement of Quality of life in patients with hyperhidrosis with the use of oxybutynin
Description
Using a Quality of life protocol we will study if patients with hyperhidrosis using oxybutynin have an improvement in their quality of life
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
The use of oxybutynin diminishes hyperhidrosis
Description
if the use of oxybutynin diminishes hyperhidrosis
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult patients with hyperhidrosis Exclusion Criteria: Glaucoma and pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WOLOSKER NELSON, Md, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas da FMUSP
City
Sao Paulo
ZIP/Postal Code
05679040
Country
Brazil

12. IPD Sharing Statement

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

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