Treatment of Hyperhidrosis With Oxybutynin

Phase 3CompletedNCT01855256

University Hospital, Brest62 enrolled

Overview

Evaluation of the effectiveness of oxybutynin in hyperhidrosis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hyperhidrosis

Interventions

OxybutyninDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

CHG de Morlaix

Morlaix, France, France

Hospital, Brest

Brest, France

CHG Landerneau

Landerneau, France

Dermatologist'S Office

Quimper, France

Outcomes

Primary Outcomes

Evaluation of the effectiveness of oxybutynin in hyperhidrosis

Two scales are used for this evaluation (Hyperhydrosis Disease Severity Scale and Dermatology Life Quality Index )

Time frame: 6 weeks

Secondary Outcomes

Safety evaluation of treatment in this indication

Number of Participants with Adverse Events will be followed.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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