Treatment of Hyperhidrosis With Oxybutynin (H²O)

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 3

Conditions: Hyperhidrosis

Treatments: Drug: Oxybutynin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01855256

RB 12.035 H²O

Details and patient eligibility

About

Evaluation of the effectiveness of oxybutynin in hyperhidrosis

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups, including a placebo group

oxybutynin

Experimental group

Description:

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.

Treatment:

Drug: Oxybutynin

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo