Treatment of Hyperhidrosis With Oxybutynin

Phase 3

Completed

• Conditions: Hyperhidrosis
• Interventions: Drug: Placebo; Drug: Oxybutynin

• Registration Number: NCT01855256
• Lead Sponsor: University Hospital, Brest

Brief Summary

Evaluation of the effectiveness of oxybutynin in hyperhidrosis

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-16
• Study Start: 2013-06
• Primary Completion: 2014-02
• Study Completion: 2014-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-07
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
oxybutynin	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety evaluation of treatment in this indication	6 weeks	Number of Participants with Adverse Events will be followed.

Trial Locations

Locations (4)

CHG de Morlaix; 🇫🇷 Morlaix, France

Hospital, Brest; 🇫🇷 Brest, France

CHG Landerneau; 🇫🇷 Landerneau, France

Dermatologist'S Office; 🇫🇷 Quimper, France