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

Primary Purpose

Hyperhidrosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Sponsored by
Allergan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis focused on measuring Axillary Hyperhidrosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Marked axillary hyperhidrosis Exclusion Criteria: Previous use of botulinum toxin for hyperhidrosis

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Subject's assessment of the severity of hyperhidrosis

    Secondary Outcome Measures

    Measurement of axillary sweat production

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    May 27, 2011
    Sponsor
    Allergan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00168402
    Brief Title
    A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2002 (undefined)
    Primary Completion Date
    October 2005 (Actual)
    Study Completion Date
    October 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Allergan

    4. Oversight

    5. Study Description

    Brief Summary
    This is a three-year study in subjects with axillary hyperhidrosis involving injection of Botulinum Toxin Type A into the axilla to reduce sweating.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperhidrosis
    Keywords
    Axillary Hyperhidrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    193 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Botulinum Toxin Type A
    Primary Outcome Measure Information:
    Title
    Subject's assessment of the severity of hyperhidrosis
    Secondary Outcome Measure Information:
    Title
    Measurement of axillary sweat production

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Marked axillary hyperhidrosis Exclusion Criteria: Previous use of botulinum toxin for hyperhidrosis

    12. IPD Sharing Statement

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

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