Use of Oxybutynin to Treat Axillary Hyperhidrosis

Not Applicable

Completed

• Conditions: Axillary Hyperhidrosis; Osmidrosis
• Interventions: Drug: Oxybutynin; Drug: Placebo

• Registration Number: NCT01118429
• Lead Sponsor: Grupo de Cirurgia Vascular

Brief Summary

The objective of this study was to evaluate the effectiveness and patient satisfaction with the use of oxybutynin at low doses for treating axillary hyperhidrosis in a large series of patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2010-03
• Study First Submitted: 2010-04-29
• Study First Submitted QC: 2010-05-05
• Last Update Submitted: 2010-05-05
• Study First Posted: 2010-05-06
• Last Update Posted: 2010-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients with axillary hyperhidrosis

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Exclusion Criteria

• glaucoma and micturition disorders, pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxybutynin	Oxybutynin	Oxybutynin was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutynin into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.
Placebo	Placebo	Oxybutyinine was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutyn into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.

Primary Outcome Measures

Name	Time	Method
Effectiveness of treatment using a clinical questionnaire	After 12 weeks of treatment	These evaluations were used to assess (1) the patients' clinical improvement in axillary hyperhidrosis, using a clinical questionnaire: de Campos JR, Kauffman P, Werebe Ede C, Andrade Filho LO, Kusniek S, Wolosker N, Jatene FB.Quality of life, before and after thoracic sympathectomy: report on 378 operated patients.Ann Thorac Surg. 2003 Sep;76(3):886-91
Effectiveness of treatment by a clinical questionnaire	6 weeks of treatment	These evaluations were used to assess (1) the patients' clinical improvement in axillary hyperhidrosis, using a clinical questionnaire, published at 2003: de Campos JR, Kauffman P, Werebe Ede C, Andrade Filho LO, Kusniek S, Wolosker N, Jatene FB.Quality of life, before and after thoracic sympathectomy: report on 378 operated patients.Ann Thorac Surg. 2003 Sep;76(3):886-91

Secondary Outcome Measures

Name	Time	Method
Treatment of hyperhidrosis at other sites	6 weeks	These evaluations were used to assess (1) the patients' clinical improvement in hyperhidrosis at other sites, using a clinical questionnaire.

Trial Locations

Locations (1)

Hospital das Clinicas da FMUSP; 🇧🇷 Sao Paulo, Brazil