Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study
Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperhidrosis
Intervention: Oxybutynin (Drug); placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Sao Paulo Official(s) and/or principal investigator(s): WOLOSKER NELSON, Md, PhD, Principal Investigator, Affiliation: University of Sao Paulo
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.
Clinical Details
Official title: Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Improvement of Quality of life in patients with hyperhidrosis with the use of oxybutynin
Secondary outcome: The use of oxybutynin diminishes hyperhidrosis
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).
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult patients with hyperhidrosis
Exclusion Criteria:
- Glaucoma and pregnancy
Locations and Contacts
Hospital das Clinicas da FMUSP, Sao Paulo 05679040, Brazil
Additional Information
Starting date: December 2010
Last updated: September 21, 2011
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