Use of Oxybutynin to Treat Axillary Hyperhidrosis

This study has been completed.
Sponsor:
Information provided by:
Grupo de Cirurgia Vascular
ClinicalTrials.gov Identifier:
NCT01118429
First received: April 29, 2010
Last updated: May 5, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Axillary Hyperhidrosis
Osmidrosis
Drug: Oxybutynin
Drug: Placebo

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Oxybutynin to Treat Axillary Hyperhidrosis

Resource links provided by NLM:


Further study details as provided by Grupo de Cirurgia Vascular:

Primary Outcome Measures:
  • Effectiveness of treatment by a clinical questionnaire [ Time Frame: 6 weeks of treatment ] [ Designated as safety issue: No ]

    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


  • Effectiveness of treatment using a clinical questionnaire [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Treatment of hyperhidrosis at other sites [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    These evaluations were used to assess (1) the patients' clinical improvement in hyperhidrosis at other sites, using a clinical questionnaire.


Enrollment: 100
Study Start Date: January 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   14 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with axillary hyperhidrosis

Exclusion Criteria:

  • glaucoma and micturition disorders, pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118429

Locations
Brazil
Hospital das Clinicas da FMUSP
Sao Paulo, Brazil, 04534000
Sponsors and Collaborators
Grupo de Cirurgia Vascular
Investigators
Principal Investigator: Nelson Wolosker, MD, PhD Hospital das Clinicas, University of Sao Paulo
  More Information

Publications:
Responsible Party: Nelson Wolosker, HCFMUSP
ClinicalTrials.gov Identifier: NCT01118429     History of Changes
Other Study ID Numbers: 0083/10
Study First Received: April 29, 2010
Last Updated: May 5, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Grupo de Cirurgia Vascular:
hyperhidrosis
axillary
osmidrosis
oxybutynin

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Oxybutynin
Mandelic Acids
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
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Renal Agents

ClinicalTrials.gov processed this record on July 20, 2014