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

NCT ID: NCT00168480

Last Updated: 2008-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

424 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-04-30

Brief Summary

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This is a three year open-label study in subjects with axillary hyperhidrosis.

Detailed Description

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Conditions

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Hyperhidrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Botulinum Toxin Type A

Group Type EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type BIOLOGICAL

100 U, repeated treatments at \> 4 month intervals up to Month 32, over a 36-month study period

Interventions

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Botulinum Toxin Type A

100 U, repeated treatments at \> 4 month intervals up to Month 32, over a 36-month study period

Intervention Type BIOLOGICAL

Other Intervention Names

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BOTOX®

Eligibility Criteria

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Inclusion Criteria

* Marked axillary hyperhidrosis

Exclusion Criteria

* Previous use of botulinum toxin for hyperhidrosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Allergan, Inc.

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Portland, Oregon, United States

Site Status

Pinneberg, , Germany

Site Status

Gothenburg, , Sweden

Site Status

Nottingham, , United Kingdom

Site Status

Countries

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United States Germany Sweden United Kingdom

Other Identifiers

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191622-513

Identifier Type: -

Identifier Source: org_study_id