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

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01310712
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
3
Duration (Months)
16.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study.
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Feb 1, 2011
Actual Study Completion Date :
Mar 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: oxybutynin

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

Drug: Oxybutynin
5 mg every 12 hours for 6 weeks
Placebo Comparator: Placebo

Placebo

Drug: placebo
placebo twice a day for 42 days.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. The use of oxybutynin diminishes hyperhidrosis [6 weeks]

    if the use of oxybutynin diminishes hyperhidrosis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adult patients with hyperhidrosis
Exclusion Criteria:
  • Glaucoma and pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital das Clinicas da FMUSP Sao Paulo Brazil 05679040

Sponsors and Collaborators

  • University of Sao Paulo

Investigators

  • Principal Investigator: WOLOSKER NELSON, Md, PhD, University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nelson Wolosker, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01310712
Other Study ID Numbers:
  • University of Sao Paulo
First Posted:
Mar 8, 2011
Last Update Posted:
Sep 22, 2011
Last Verified:
Mar 1, 2011
Keywords provided by Nelson Wolosker, MD, PhD, University of Sao Paulo
hyperhidrosis
oxybutynin
Additional relevant MeSH terms:
Hyperhidrosis
Oxybutynin

Study Results

No Results Posted as of Sep 22, 2011