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

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ClinicalTrials.gov Identifier: NCT00168402
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 30, 2011
Sponsor:
Information provided by:
Allergan

Brief Summary:
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 or disease Intervention/treatment Phase
Hyperhidrosis Drug: Botulinum Toxin Type A Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2002
Primary Completion Date : October 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources




Primary Outcome Measures :
  1. Subject's assessment of the severity of hyperhidrosis

Secondary Outcome Measures :
  1. Measurement of axillary sweat production


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

Responsible Party: Therapeutic Area Head, Allergan, Inc
ClinicalTrials.gov Identifier: NCT00168402     History of Changes
Other Study ID Numbers: 191622-046
First Posted: September 15, 2005    Key Record Dates
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