Treatment of Hyperhidrosis With Oxybutynin

NCT01855256 | Completed Phase 3 DMC

• 1 other identifier: RB 12.035 H²O
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 4

Brief Summary

Evaluation of the effectiveness of oxybutynin in hyperhidrosis

Conditions

Hyperhidrosis

Keywords

hyperhidrosis; oxybutynin

Outcome Measures

Primary Outcomes (1)

• Evaluation of the effectiveness of oxybutynin in hyperhidrosis

  Two scales are used for this evaluation (Hyperhydrosis Disease Severity Scale and Dermatology Life Quality Index )

  6 weeks

Secondary Outcomes (1)

• Safety evaluation of treatment in this indication

  6 weeks

Study Arms (2)

oxybutynin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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.

oxybutynin

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead
• Ministry of Health, France: collaborator

Study Sites (4)

CHG de Morlaix

Morlaix, France, 29600, France

Location

Hospital, Brest

Brest, 29609, France

Location

CHG Landerneau

Landerneau, 29800, France

Location

Dermatologist'S Office

Quimper, 29000, France

Location

Related Publications (1)

• Schollhammer M, Brenaut E, Menard-Andivot N, Pillette-Delarue M, Zagnoli A, Chassain-Le Lay M, Sassolas B, Jouan N, Le Ru Y, Abasq-Thomas C, Greco M, Penven K, Roguedas-Contios AM, Dupre-Goetghebeur D, Gouedard C, Misery L, Le Gal G. Oxybutynin as a treatment for generalized hyperhidrosis: a randomized, placebo-controlled trial. Br J Dermatol. 2015 Nov;173(5):1163-8. doi: 10.1111/bjd.13973. Epub 2015 Oct 14.

  PMID: 26114588 RESULT

MeSH Terms

Conditions

Hyperhidrosis

Interventions

oxybutynin

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Martine SCHOLLHAMMER, MD

  ADBO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 16, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 3, 2025

Record last verified: 2014-07

Locations

FR (4)