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Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study

Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01310712
Enrollment
50
Registered
2011-03-08
Start date
2010-12-31
Completion date
2011-03-31
Last updated
2011-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperhidrosis

Keywords

hyperhidrosis, oxybutynin

Brief summary

Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.

Detailed description

Introduction: Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects. Purpose: The objective of this study is to evaluate the effectiveness and patient satisfaction with the use of oxybutynin at low doses comparing to placebo for treating palmar hyperhidrosis. Methods: This is a prospective, randomized and controlled study. From December 2010 to february 2011, 50 consecutive patients with palmar hyperhidrosis were treated with oxybutynin or placebo. Data were collected from 50 patients, and 5 (10,0%) patients were lost to follow-up. During the first week, patients received 2.5 mg of oxybutynin once a day in the evening. From the 8th to the 42nd day, they received 2.5 mg twice a day, and from the 43rd day to the end of the 12th week, they received 5 mg twice a day. All of the patients underwent 2 evaluations: before and after (12 weeks) the oxybutynin treatment, using a clinical questionnaire; and a clinical protocol for quality of life (QOL).

Interventions

DRUGOxybutynin

5 mg every 12 hours for 6 weeks

DRUGplacebo

placebo twice a day for 42 days.

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Adult patients with hyperhidrosis

Exclusion criteria

* Glaucoma and pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Improvement of Quality of life in patients with hyperhidrosis with the use of oxybutynin6 weeksUsing a Quality of life protocol we will study if patients with hyperhidrosis using oxybutynin have an improvement in their quality of life

Secondary

MeasureTime frameDescription
The use of oxybutynin diminishes hyperhidrosis6 weeksif the use of oxybutynin diminishes hyperhidrosis

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026