H²O: Treatment of Hyperhidrosis With Oxybutynin

• Sponsor: University Hospital, Brest (Other)
• Overall Status: Completed
• CT.gov ID: NCT01855256
• Collaborator: Ministry of Health, France (Other)
• Enrollment: 62
• Locations: 4
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 15.5
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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

• Study Type: Interventional
• 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: Jun 1, 2013
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

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

Primary Outcome Measures

1. 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 Outcome Measures

1. Safety evaluation of treatment in this indication [6 weeks]

   Number of Participants with Adverse Events will be followed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital, Brest	Brest		France	29609
2	CHG Landerneau	Landerneau		France	29800
3	CHG de Morlaix	Morlaix		France	29600
4	Dermatologist'S Office	Quimper		France	29000

Sponsors and Collaborators

• University Hospital, Brest
• Ministry of Health, France

Investigators

• Principal Investigator: Martine SCHOLLHAMMER, MD, ADBO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Brest
• ClinicalTrials.gov Identifier: NCT01855256
• Other Study ID Numbers: RB 12.035 H²O
• First Posted: May 16, 2013
• Last Update Posted: Jul 8, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by University Hospital, Brest: hyperhidrosis; oxybutynin
• Additional relevant MeSH terms: Hyperhidrosis; Oxybutynin

Study Results

No Results Posted as of Jul 8, 2014