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

NCT ID: NCT00168415

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

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-06-30

Brief Summary

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A study using Botulinum Toxin Type A in adolescents 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 up to 6 times during the study depending on the response to treatment

Interventions

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Botulinum Toxin Type A

100 U up to 6 times during the study depending on the response to treatment

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

12 Years

Maximum Eligible Age

17 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

Vancouver, British Columbia, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 26059781 (View on PubMed)

Other Identifiers

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191622-075

Identifier Type: -

Identifier Source: org_study_id