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Completed

NCT Number: NCT01118429

Use of Oxybutynin to Treat Axillary Hyperhidrosis

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.

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Key information

Conditions

Axillary Hyperhidrosis Body Odor Hyperhidrosis Osmidrosis Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

14 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clinicas da FMUSP

São Paulo, 04534000, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with axillary hyperhidrosis

Exclusion criteria

  • glaucoma and micturition disorders, pregnancy

Treatment and study plan

Oxybutynin

Drug

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

Drug

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 outcomes

  1. Effectiveness of treatment by a clinical questionnaire

    Time frame: 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

  2. Effectiveness of treatment using a clinical questionnaire

    Time frame: 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

Secondary outcomes

  1. Treatment of hyperhidrosis at other sites

    Time frame: 6 weeks

    These evaluations were used to assess (1) the patients' clinical improvement in hyperhidrosis at other sites, using a clinical questionnaire.

Sponsors and collaborators

Lead sponsor

Grupo de Cirurgia Vascular

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 6, 2010
Registry last updated
May 6, 2010

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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