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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

Page last updated: August 23, 2015

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