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:
NCT00168480
First received: September 13, 2005
Last updated: September 26, 2008
Last verified: September 2008
  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
Endpoint Classification: Safety/Efficacy 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:
  • Assessment of axillary sweat production [ Time Frame: Every 4 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient reported health outcome measures [ Time Frame: 1 Month Post-Treatment Visit ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
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.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00168480     History of Changes
Other Study ID Numbers: 191622-513
Study First Received: September 13, 2005
Last Updated: September 26, 2008
Health Authority: United States: Food and Drug Administration

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