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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nelson Wolosker, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01310712
First received: March 7, 2011
Last updated: September 21, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Hyperhidrosis
Drug: Oxybutynin
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Improvement of Quality of life in patients with hyperhidrosis with the use of oxybutynin [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    if the use of oxybutynin diminishes hyperhidrosis


Enrollment: 50
Study Start Date: December 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients with hyperhidrosis

Exclusion Criteria:

  • Glaucoma and pregnancy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01310712

Locations
Brazil
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
  More Information

No publications provided

Responsible Party: Nelson Wolosker, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01310712     History of Changes
Other Study ID Numbers: University of Sao Paulo
Study First Received: March 7, 2011
Last Updated: September 21, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
hyperhidrosis
oxybutynin

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Oxybutynin
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014