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A 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
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
September 13, 2005
Last Updated
September 26, 2008
Sponsor
Allergan
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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

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

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