Treatment of Hyperhidrosis With Oxybutynin (H²O)

November 26, 2025 updated by: University Hospital, Brest

Treatment of Hyperhidrosis With Oxybutynin: a Randomized Controlled Double Blind Against Placebo

Evaluation of the effectiveness of oxybutynin in hyperhidrosis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • Hospital, Brest
      • Landerneau, France, 29800
        • CHG Landerneau
      • Quimper, France, 29000
        • Dermatologist'S Office
    • France
      • Morlaix, France, France, 29600
        • CHG de Morlaix

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age greater than 18 years
  • Patient affiliated to social security or beneficiary of such a regime
  • Patient able to consent
  • Patient with hyperhidrosis, generalized or localized (palmar, plantar, axillary) and whose score HDSS (Hyperidrosis Disease Severity Scale) is greater than two.

Exclusion Criteria:

  • Age less than 18 years
  • Patient who can't be followed
  • Patient participating in another clinical trial
  • Pregnant
  • Woman breastfeeding
  • Hypersensitivity to oxybutynin or any of the excipients
  • Risk of urinary retention related disorders uretroprostatiques
  • Intestinal obstruction
  • Toxic megacolon
  • Intestinal atony
  • Severe Ulcerative Colitis
  • Myasthenia
  • Closure glaucoma the anterior chamber angle or slightly deep

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: oxybutynin
Oxybutynin was done at 2.5 mg/day from day 1 to day 4, then at 5 mg/day from day 5 to day 7 and at 7.5 mg/day from day 8 to the end of the 6 weeks.
Drug: Oxybutynin
Oxybutynin is started at a dose of 2.5 mg / day and increased gradually until an effective dose without exceed 7.5 mg / day up to 6 weeks.
Placebo Comparator: Placebo
Placebo was done at 2.5 mg/day from day 1 to day 4, then at 5 mg/day from day 5 to day 7 and at 7.5 mg/day from day 8 to the end of the 6 weeks.
Drug: Placebo
Placebo is started at a dose of 2.5 mg / day and increased gradually until an effective dose without exceed 7.5 mg / day up to 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the effectiveness of oxybutynin in hyperhidrosis
Time Frame: 6 weeks
Two scales are used for this evaluation (Hyperhydrosis Disease Severity Scale and Dermatology Life Quality Index )
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety evaluation of treatment in this indication
Time Frame: 6 weeks
Number of Participants with Adverse Events will be followed.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Martine SCHOLLHAMMER, MD, ADBO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

May 15, 2013

First Posted (Estimated)

May 16, 2013

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RB 12.035 H²O

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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