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Completed

NCT Number: NCT01855256

Treatment of Hyperhidrosis With Oxybutynin

Evaluation of the effectiveness of oxybutynin in hyperhidrosis

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Key information

Conditions

Hyperhidrosis Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHG de Morlaix, Morlaix, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxybutynin

Drug

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

Drug

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.

Primary outcomes

  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 outcomes

  1. Safety evaluation of treatment in this indication

    Time frame: 6 weeks

    Number of Participants with Adverse Events will be followed.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Treatment of Hyperhidrosis With Oxybutynin: a Randomized Controlled Double Blind Against Placebo

Acronym: H²O

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 16, 2013
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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