Hyperhidrosis
Conditions
Keywords
hyperhidrosis, oxybutynin
Brief summary
Evaluation of the effectiveness of oxybutynin in hyperhidrosis
Interventions
DRUGOxybutynin
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.
DRUGPlacebo
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.
Sponsors
Ministry of Health, France
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the effectiveness of oxybutynin in hyperhidrosis | 6 weeks | Two scales are used for this evaluation (Hyperhydrosis Disease Severity Scale and Dermatology Life Quality Index ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation of treatment in this indication | 6 weeks | Number of Participants with Adverse Events will be followed. |
Countries
France
Outcome results
None listed