Treatment of Hyperhidrosis With Oxybutynin (H²O)
|ClinicalTrials.gov Identifier: NCT01855256|
Recruitment Status : Completed
First Posted : May 16, 2013
Last Update Posted : July 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hyperhidrosis||Drug: Oxybutynin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Treatment of Hyperhidrosis With Oxybutynin: a Randomized Controlled Double Blind Against Placebo|
|Study Start Date :||June 2013|
|Primary Completion Date :||February 2014|
|Study Completion Date :||March 2014|
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.
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.
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.
- 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 )
- Safety evaluation of treatment in this indication [ Time Frame: 6 weeks ]Number of Participants with Adverse Events will be followed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855256
|Brest, France, 29609|
|Landerneau, France, 29800|
|CHG de Morlaix|
|Morlaix, France, 29600|
|Quimper, France, 29000|
|Principal Investigator:||Martine SCHOLLHAMMER, MD||ADBO|