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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01310712
Recruitment Status : Completed
First Posted : March 8, 2011
Last Update Posted : September 22, 2011
Sponsor:
Information provided by (Responsible Party):
Nelson Wolosker, University of Sao Paulo

Study Description
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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
Hyperhidrosis Drug: Oxybutynin Drug: placebo 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
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Study Type : Interventional  (Clinical Trial)
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 : December 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Improvement of Quality of life in patients with hyperhidrosis with the use of oxybutynin [ Time Frame: 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 [ Time Frame: 6 weeks ]
    if the use of oxybutynin diminishes hyperhidrosis


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients with hyperhidrosis

Exclusion Criteria:

  • Glaucoma and pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310712


Locations
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Brazil
Hospital das Clinicas da FMUSP
Sao Paulo, Brazil, 05679040
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: WOLOSKER NELSON, Md, PhD University of Sao Paulo
More Information
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Responsible Party: Nelson Wolosker, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01310712    
Other Study ID Numbers: University of Sao Paulo
First Posted: March 8, 2011    Key Record Dates
Last Update Posted: September 22, 2011
Last Verified: March 2011
Keywords provided by Nelson Wolosker, University of Sao Paulo:
hyperhidrosis
oxybutynin
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Oxybutynin
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents