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

Hyperhidrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310712
• Other study ID #: University of Sao Paulo
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2011
• Last updated: September 21, 2011
• Start date: December 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Adult patients with hyperhidrosis

Exclusion Criteria:

• Glaucoma and pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Drug:
• Oxybutynin
5 mg every 12 hours for 6 weeks
• placebo
placebo twice a day for 42 days.

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da FMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of Quality of life in patients with hyperhidrosis with the use of oxybutynin	Using a Quality of life protocol we will study if patients with hyperhidrosis using oxybutynin have an improvement in their quality of life	6 weeks	Yes
Secondary	The use of oxybutynin diminishes hyperhidrosis	if the use of oxybutynin diminishes hyperhidrosis	6 weeks	Yes