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Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) in Korea

NCT ID: NCT02043145

Last Updated: 2014-06-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

727 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-04-30

Brief Summary

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This post marketing surveillance study in Korea will evaluate the safety and efficacy of BOTOX (botulinum toxin Type A) in patients who receive treatment according to standard of care for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines in clinical practice.

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Detailed Description

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Conditions

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Hyperhidrosis Muscle Spasticity Glabellar Lines

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Axillary Hyperhidrosis

Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.

botulinum toxin Type A

Intervention Type BIOLOGICAL

Botulinum toxin Type A (BOTOX®) as prescribed according to standard of care in clinical practice.

Focal Spasticity

Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.

botulinum toxin Type A

Intervention Type BIOLOGICAL

Botulinum toxin Type A (BOTOX®) as prescribed according to standard of care in clinical practice.

Glabellar Lines

Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.

botulinum toxin Type A

Intervention Type BIOLOGICAL

Botulinum toxin Type A (BOTOX®) as prescribed according to standard of care in clinical practice.

Interventions

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botulinum toxin Type A

Botulinum toxin Type A (BOTOX®) as prescribed according to standard of care in clinical practice.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines.

Exclusion Criteria

* None.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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EPI-MULT-100

Identifier Type: -

Identifier Source: org_study_id

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