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Treatment of Hyperhidrosis With Oxybutynin (H²O)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01855256
Recruitment Status : Completed
First Posted : May 16, 2013
Last Update Posted : July 8, 2014
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
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Brief Summary:
Evaluation of the effectiveness of oxybutynin in hyperhidrosis

Condition or disease Intervention/treatment Phase
Hyperhidrosis Drug: Oxybutynin Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Hyperhidrosis With Oxybutynin: a Randomized Controlled Double Blind Against Placebo
Study Start Date : June 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 )


Secondary Outcome Measures :
  1. Safety evaluation of treatment in this indication [ Time Frame: 6 weeks ]
    Number of Participants with Adverse Events will be followed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855256


Locations
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France
Hospital, Brest
Brest, France, 29609
CHG Landerneau
Landerneau, France, 29800
CHG de Morlaix
Morlaix, France, 29600
Dermatologist'S Office
Quimper, France, 29000
Sponsors and Collaborators
University Hospital, Brest
Ministry of Health, France
Investigators
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Principal Investigator: Martine SCHOLLHAMMER, MD ADBO
More Information
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01855256    
Other Study ID Numbers: RB 12.035 H²O
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Keywords provided by University Hospital, Brest:
hyperhidrosis
oxybutynin
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Oxybutynin
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents