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

This study has been completed.
Information provided by:
Allergan Identifier:
First received: September 13, 2005
Last updated: September 26, 2008
Last verified: September 2008
A study using Botulinum Toxin Type A in adolescents with axillary hyperhidrosis.

Condition Intervention Phase
Biological: Botulinum Toxin Type A
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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 using the HDS Scale [ Time Frame: Monthly ]

Secondary Outcome Measures:
  • Measurement of axillary sweat production [ Time Frame: Week 4, Week 8 and any re-injection visit ]

Enrollment: 144
Study Start Date: August 2005
Study Completion Date: June 2007
Primary Completion Date: June 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 up to 6 times during the study depending on the response to treatment
Other Name: BOTOX®


Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Marked axillary hyperhidrosis

Exclusion Criteria:

  • Previous use of botulinum toxin for hyperhidrosis
  Contacts and Locations
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Please refer to this study by its identifier: NCT00168415

United States, Oregon
Portland, Oregon, United States
Canada, British Columbia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Study Director: Medical Director Allergan
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Allergan, Inc. Identifier: NCT00168415     History of Changes
Other Study ID Numbers: 191622-075
Study First Received: September 13, 2005
Last Updated: September 26, 2008

Additional relevant MeSH terms:
Sweat Gland Diseases
Skin Diseases
Botulinum Toxins
Botulinum Toxins, Type A
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 processed this record on April 21, 2017