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
About this trial
This is an interventional treatment trial for Hyperhidrosis focused on measuring hyperhidrosis, oxybutynin
Eligibility Criteria
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
NCT ID
NCT01310712
First Posted
March 7, 2011
Last Updated
September 21, 2011
Sponsor
University of Sao Paulo
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
Learn more about this trial
Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study
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