Use of Oxybutynin to Treat Axillary Hyperhidrosis

May 5, 2010 updated by: Grupo de Cirurgia Vascular
The objective of this study was to evaluate the effectiveness and patient satisfaction with the use of oxybutynin at low doses for treating axillary hyperhidrosis in a large series of patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04534000
        • Hospital das Clinicas da FMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with axillary hyperhidrosis

Exclusion Criteria:

  • glaucoma and micturition disorders, pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxybutynin
Oxybutynin was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutynin into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.
Drug: Oxybutynin
Oxybutynin was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutynin into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.
Placebo Comparator: Placebo
Oxybutyinine was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutyn into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.
Drug: Placebo
Oxybutyinine was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutyn into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of treatment by a clinical questionnaire
Time Frame: 6 weeks of treatment

These evaluations were used to assess (1) the patients' clinical improvement in axillary hyperhidrosis, using a clinical questionnaire, published at 2003:

de Campos JR, Kauffman P, Werebe Ede C, Andrade Filho LO, Kusniek S, Wolosker N, Jatene FB.Quality of life, before and after thoracic sympathectomy: report on 378 operated patients.Ann Thorac Surg. 2003 Sep;76(3):886-91
6 weeks of treatment
Effectiveness of treatment using a clinical questionnaire
Time Frame: After 12 weeks of treatment

These evaluations were used to assess (1) the patients' clinical improvement in axillary hyperhidrosis, using a clinical questionnaire:

de Campos JR, Kauffman P, Werebe Ede C, Andrade Filho LO, Kusniek S, Wolosker N, Jatene FB.Quality of life, before and after thoracic sympathectomy: report on 378 operated patients.Ann Thorac Surg. 2003 Sep;76(3):886-91
After 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment of hyperhidrosis at other sites
Time Frame: 6 weeks
These evaluations were used to assess (1) the patients' clinical improvement in hyperhidrosis at other sites, using a clinical questionnaire.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Cirurgia Vascular

Investigators

  • Principal Investigator: Nelson Wolosker, MD, PhD, Hospital das Clinicas, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

April 29, 2010

First Submitted That Met QC Criteria

May 5, 2010

First Posted (Estimate)

May 6, 2010

Study Record Updates

Last Update Posted (Estimate)

May 6, 2010

Last Update Submitted That Met QC Criteria

May 5, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0083/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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