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

Overview

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.

Full Title of Study: “Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 2011

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).

Interventions

  • Drug: Oxybutynin
    • 5 mg every 12 hours for 6 weeks
  • Drug: placebo
    • placebo twice a day for 42 days.

Arms, Groups and Cohorts

  • Experimental: oxybutynin
    • patients will receive in the end of the treatment, 10 mg of oxybutynin a day
  • Placebo Comparator: Placebo
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • The use of oxybutynin diminishes hyperhidrosis
    • Time Frame: 6 weeks
    • if the use of oxybutynin diminishes hyperhidrosis

Participating in This Clinical Trial

Inclusion Criteria

  • Adult patients with hyperhidrosis Exclusion Criteria:
  • Glaucoma and pregnancy
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 60 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • University of Sao Paulo
    • Provider of Information About this Clinical Study
      • Principal Investigator: Nelson Wolosker, MD, PhD – University of Sao Paulo
    • Overall Official(s)
      • WOLOSKER NELSON, Md, PhD, Principal Investigator, University of Sao Paulo

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