Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study
|ClinicalTrials.gov Identifier: NCT01310712|
Recruitment Status : Completed
First Posted : March 8, 2011
Last Update Posted : September 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hyperhidrosis||Drug: Oxybutynin Drug: placebo||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study.|
|Study Start Date :||December 2010|
|Primary Completion Date :||February 2011|
|Study Completion Date :||March 2011|
patients will receive in the end of the treatment, 10 mg of oxybutynin a day
5 mg every 12 hours for 6 weeks
Placebo Comparator: Placebo
placebo twice a day for 42 days.
- 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
- The use of oxybutynin diminishes hyperhidrosis [ Time Frame: 6 weeks ]if the use of oxybutynin diminishes hyperhidrosis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310712
|Hospital das Clinicas da FMUSP|
|Sao Paulo, Brazil, 05679040|
|Principal Investigator:||WOLOSKER NELSON, Md, PhD||University of Sao Paulo|