Back to resultsUse of Oxybutynin to Treat Axillary Hyperhidrosis
Primary Purpose
Axillary Hyperhidrosis, Osmidrosis
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Oxybutynin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Axillary Hyperhidrosis focused on measuring hyperhidrosis, axillary, osmidrosis, oxybutynin
Eligibility Criteria
Inclusion Criteria:
- patients with axillary hyperhidrosis
Exclusion Criteria:
- glaucoma and micturition disorders, pregnancy
Sites / Locations
- Hospital das Clinicas da FMUSP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oxybutynin
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Effectiveness of treatment by a clinical questionnaire
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
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
These evaluations were used to assess (1) the patients' clinical improvement in hyperhidrosis at other sites, using a clinical questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01118429
Brief Title
Use of Oxybutynin to Treat Axillary Hyperhidrosis
Official Title
Use of Oxybutynin to Treat Axillary Hyperhidrosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Grupo de Cirurgia Vascular
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axillary Hyperhidrosis, Osmidrosis
Keywords
hyperhidrosis, axillary, osmidrosis, oxybutynin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxybutynin
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Oxybutynin
Intervention Description
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 Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of treatment by a clinical questionnaire
Description
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
Time Frame
6 weeks of treatment
Title
Effectiveness of treatment using a clinical questionnaire
Description
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
Time Frame
After 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Treatment of hyperhidrosis at other sites
Description
These evaluations were used to assess (1) the patients' clinical improvement in hyperhidrosis at other sites, using a clinical questionnaire.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with axillary hyperhidrosis
Exclusion Criteria:
glaucoma and micturition disorders, pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelson Wolosker, MD, PhD
Organizational Affiliation
Hospital das Clinicas, University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas da FMUSP
City
Sao Paulo
ZIP/Postal Code
04534000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
20299178
Citation
Wolosker N, Yazbek G, de Campos JR, Munia MA, Kauffman P, Jatene FB, Puech-Leao P. Quality of life before surgery is a predictive factor for satisfaction among patients undergoing sympathectomy to treat hyperhidrosis. J Vasc Surg. 2010 May;51(5):1190-4. doi: 10.1016/j.jvs.2009.11.078. Epub 2010 Mar 29.
Results Reference
background
PubMed Identifier
20233806
Citation
de Campos JR, Wolosker N, Yazbek G, Munia MA, Kauffman P, Puech-Leao P, Jatene FB. Comparison of pain severity following video-assisted thoracoscopic sympathectomy: electric versus harmonic scalpels. Interact Cardiovasc Thorac Surg. 2010 Jun;10(6):919-22. doi: 10.1510/icvts.2009.225383. Epub 2010 Mar 16.
Results Reference
background
PubMed Identifier
19690657
Citation
Yazbek G, Wolosker N, Kauffman P, Campos JR, Puech-Leao P, Jatene FB. Twenty months of evolution following sympathectomy on patients with palmar hyperhidrosis: sympathectomy at the T3 level is better than at the T2 level. Clinics (Sao Paulo). 2009;64(8):743-9. doi: 10.1590/S1807-59322009000800006.
Results Reference
background
PubMed Identifier
19060999
Citation
Munia MA, Wolosker N, Kaufmann P, de Campos JR, Puech-Leao P. Sustained benefit lasting one year from T4 instead of T3-T4 sympathectomy for isolated axillary hyperhidrosis. Clinics (Sao Paulo). 2008 Dec;63(6):771-4. doi: 10.1590/s1807-59322008000600011.
Results Reference
background
PubMed Identifier
18266585
Citation
Wolosker N, Yazbek G, Ishy A, de Campos JR, Kauffman P, Puech-Leao P. Is sympathectomy at T4 level better than at T3 level for treating palmar hyperhidrosis? J Laparoendosc Adv Surg Tech A. 2008 Feb;18(1):102-6. doi: 10.1089/lap.2007.0030.
Results Reference
background
PubMed Identifier
17210397
Citation
Munia MA, Wolosker N, Kauffman P, de Campos JR, Puech-Leao P. A randomized trial of T3-T4 versus T4 sympathectomy for isolated axillary hyperhidrosis. J Vasc Surg. 2007 Jan;45(1):130-3. doi: 10.1016/j.jvs.2006.09.011.
Results Reference
background
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Use of Oxybutynin to Treat Axillary Hyperhidrosis
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