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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:
NCT00168402
First Posted: September 15, 2005
Last Update Posted: May 30, 2011
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 study in subjects with axillary hyperhidrosis involving injection of Botulinum Toxin Type A into the axilla to reduce sweating.

Condition Intervention Phase
Hyperhidrosis Drug: Botulinum Toxin Type A Phase 3

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:
  • Subject's assessment of the severity of hyperhidrosis

Secondary Outcome Measures:
  • Measurement of axillary sweat production

Enrollment: 193
Study Start Date: February 2002
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (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
No Contacts or Locations Provided
  More Information

Responsible Party: Therapeutic Area Head, Allergan, Inc
ClinicalTrials.gov Identifier: NCT00168402     History of Changes
Other Study ID Numbers: 191622-046
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: May 30, 2011
Last Verified: May 2011

Keywords provided by Allergan:
Axillary Hyperhidrosis

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