Back to resultsA Study Using Botulinum Toxin Type A in Adolescents 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
Subject's assessment of the severity of hyperhidrosis using the HDS Scale
Secondary Outcome Measures
Measurement of axillary sweat production
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00168415
Brief Title
A Study Using Botulinum Toxin Type A in Adolescents With Axillary Hyperhidrosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
A study using Botulinum Toxin Type A in adolescents 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
144 (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 up to 6 times during the study depending on the response to treatment
Primary Outcome Measure Information:
Title
Subject's assessment of the severity of hyperhidrosis using the HDS Scale
Time Frame
Monthly
Secondary Outcome Measure Information:
Title
Measurement of axillary sweat production
Time Frame
Week 4, Week 8 and any re-injection visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 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
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
26059781
Citation
Glaser DA, Pariser DM, Hebert AA, Landells I, Somogyi C, Weng E, Brin MF, Beddingfield F. A Prospective, Nonrandomized, Open-Label Study of the Efficacy and Safety of OnabotulinumtoxinA in Adolescents with Primary Axillary Hyperhidrosis. Pediatr Dermatol. 2015 Sep-Oct;32(5):609-17. doi: 10.1111/pde.12620. Epub 2015 Jun 8.
Results Reference
derived
Learn more about this trial
A Study Using Botulinum Toxin Type A in Adolescents With Axillary Hyperhidrosis
We'll reach out to this number within 24 hrs