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Completed

NCT Number: NCT01310712

Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study

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.

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Key information

Conditions

Hyperhidrosis Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital das Clinicas da FMUSP

São Paulo, 05679040, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients with hyperhidrosis

Exclusion criteria

  • Glaucoma and pregnancy

Treatment and study plan

Oxybutynin

Drug

5 mg every 12 hours for 6 weeks

Placebo

Drug

placebo twice a day for 42 days.

Primary outcomes

  1. 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

Secondary outcomes

  1. The use of oxybutynin diminishes hyperhidrosis

    Time frame: 6 weeks

    if the use of oxybutynin diminishes hyperhidrosis

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 8, 2011
Registry last updated
Sep 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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