Back to resultsTreatment of Hyperhidrosis With Oxybutynin (H²O)
Primary Purpose
Hyperhidrosis
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Oxybutynin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis focused on measuring hyperhidrosis, oxybutynin
Eligibility Criteria
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
Sites / Locations
- Hospital, Brest
- CHG Landerneau
- CHG de Morlaix
- Dermatologist'S Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
oxybutynin
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Evaluation of the effectiveness of oxybutynin in hyperhidrosis
Two scales are used for this evaluation (Hyperhydrosis Disease Severity Scale and Dermatology Life Quality Index )
Secondary Outcome Measures
Safety evaluation of treatment in this indication
Number of Participants with Adverse Events will be followed.
Full Information
NCT ID
NCT01855256
First Posted
May 13, 2013
Last Updated
July 7, 2014
Sponsor
University Hospital, Brest
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT01855256
Brief Title
Treatment of Hyperhidrosis With Oxybutynin
Acronym
H²O
Official Title
Treatment of Hyperhidrosis With Oxybutynin: a Randomized Controlled Double Blind Against Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
Ministry of Health, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation of the effectiveness of oxybutynin in hyperhidrosis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis
Keywords
hyperhidrosis, oxybutynin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oxybutynin
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxybutynin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of the effectiveness of oxybutynin in hyperhidrosis
Description
Two scales are used for this evaluation (Hyperhydrosis Disease Severity Scale and Dermatology Life Quality Index )
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Safety evaluation of treatment in this indication
Description
Number of Participants with Adverse Events will be followed.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine SCHOLLHAMMER, MD
Organizational Affiliation
ADBO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital, Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHG Landerneau
City
Landerneau
ZIP/Postal Code
29800
Country
France
Facility Name
CHG de Morlaix
City
Morlaix
ZIP/Postal Code
29600
Country
France
Facility Name
Dermatologist'S Office
City
Quimper
ZIP/Postal Code
29000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Treatment of Hyperhidrosis With Oxybutynin
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