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A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00168480
First Posted: September 15, 2005
Last Update Posted: September 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Allergan
  Purpose
This is a three year open-label study in subjects with axillary hyperhidrosis.

Condition Intervention Phase
Hyperhidrosis Biological: Botulinum Toxin Type A Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Assessment of axillary sweat production [ Time Frame: Every 4 Months ]

Secondary Outcome Measures:
  • Patient reported health outcome measures [ Time Frame: 1 Month Post-Treatment Visit ]

Enrollment: 424
Study Start Date: November 2003
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Botulinum Toxin Type A
Biological: Botulinum Toxin Type A
100 U, repeated treatments at > 4 month intervals up to Month 32, over a 36-month study period
Other Name: BOTOX®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Marked axillary hyperhidrosis

Exclusion Criteria:

  • Previous use of botulinum toxin for hyperhidrosis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168480


Locations
United States, Oregon
Portland, Oregon, United States
Germany
Pinneberg, Germany
Sweden
Goteborg, Sweden
United Kingdom
Nottingham, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00168480     History of Changes
Other Study ID Numbers: 191622-513
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: September 29, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents