Back to resultsA Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis
Primary Purpose
Hyperhidrosis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis
Eligibility Criteria
Inclusion Criteria: Marked axillary hyperhidrosis Exclusion Criteria: Previous use of botulinum toxin for hyperhidrosis
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Botulinum Toxin Type A
Outcomes
Primary Outcome Measures
Assessment of axillary sweat production
Secondary Outcome Measures
Patient reported health outcome measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00168480
Brief Title
A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
This is a three year open-label study in subjects with axillary hyperhidrosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
424 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Botulinum Toxin Type A
Intervention Type
Biological
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
BOTOX®
Intervention Description
100 U, repeated treatments at > 4 month intervals up to Month 32, over a 36-month study period
Primary Outcome Measure Information:
Title
Assessment of axillary sweat production
Time Frame
Every 4 Months
Secondary Outcome Measure Information:
Title
Patient reported health outcome measures
Time Frame
1 Month Post-Treatment Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Marked axillary hyperhidrosis
Exclusion Criteria:
Previous use of botulinum toxin for hyperhidrosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Portland
State/Province
Oregon
Country
United States
City
Pinneberg
Country
Germany
City
Goteborg
Country
Sweden
City
Nottingham
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis
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