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

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00168402
First received: September 13, 2005
Last updated: May 27, 2011
Last verified: May 2011
  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
Endpoint Classification: Safety Study
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Marked axillary hyperhidrosis

Exclusion Criteria:

  • Previous use of botulinum toxin for hyperhidrosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Therapeutic Area Head, Allergan, Inc
ClinicalTrials.gov Identifier: NCT00168402     History of Changes
Other Study ID Numbers: 191622-046
Study First Received: September 13, 2005
Last Updated: May 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Allergan:
Axillary Hyperhidrosis

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014