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

April 29, 2010
May 5, 2010
January 2007
June 2009   (final data collection date for primary outcome measure)
  • 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

Same as current
Complete list of historical versions of study NCT01118429 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Use of Oxybutynin to Treat Axillary Hyperhidrosis
Use of Oxybutynin to Treat Axillary Hyperhidrosis

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Axillary Hyperhidrosis
  • Osmidrosis
  • 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.
  • 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.
  • 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.
    Intervention: Drug: Oxybutynin
  • 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.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with axillary hyperhidrosis

Exclusion Criteria:

  • glaucoma and micturition disorders, pregnancy
Both
14 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01118429
0083/10
Yes
Nelson Wolosker, HCFMUSP
Grupo de Cirurgia Vascular
Not Provided
Principal Investigator: Nelson Wolosker, MD, PhD Hospital das Clinicas, University of Sao Paulo
Grupo de Cirurgia Vascular
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP