Safety and Efficacy of Two Types of Botulinum Toxin Type A For the Treatment of Glabellar Lines

NCT ID: NCT01271452

Last Updated: 2019-01-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-04-30

Brief Summary

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This study will evaluate the safety and efficacy of two different types of botulinum toxin type A for the treatment of glabellar frown lines.

Detailed Description

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Conditions

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Glabellar Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vistabel®

botulinum toxin type A (Vistabel®)

Group Type ACTIVE_COMPARATOR

botulinum toxin type A

Intervention Type BIOLOGICAL

20 units (total dose) botulinum toxin type A injected into glabellar region on Day 0

Bocouture®

botulinum toxin type A (Bocouture®)

Group Type ACTIVE_COMPARATOR

botulinum toxin type A

Intervention Type BIOLOGICAL

30 units (total dose) botulinum toxin type A injected into glabellar region on Day 0

Interventions

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botulinum toxin type A

20 units (total dose) botulinum toxin type A injected into glabellar region on Day 0

Intervention Type BIOLOGICAL

botulinum toxin type A

30 units (total dose) botulinum toxin type A injected into glabellar region on Day 0

Intervention Type BIOLOGICAL

Other Intervention Names

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Vistabel® BOTOX® Cosmetic Bocouture®

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe glabellar frown lines

Exclusion Criteria

* Diagnosis of myasthenia gravis or Eaton Lambert syndrome
* Aesthetic treatment with botulinum toxin within 6 months or planned treatment with botulinum toxin for any reason during the study
* Prior filler treatments, surgeries, insertion procedures in/to the glabellar region
* Facial cosmetic procedures in the glabellar area within 6 months
* Bleeding disorders or use of anticoagulants within 10 days
* History of facial nerve palsy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

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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Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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Moers-Carpi M, Dirschka T, Feller-Heppt G, Hilton S, Hoffmann K, Philipp-Dormston WG, Rutter A, Tan K, Chapman MA, Fulford-Smith A. A randomised, double-blind comparison of 20 units of onabotulinumtoxinA with 30 units of incobotulinumtoxinA for glabellar lines. J Cosmet Laser Ther. 2012 Dec;14(6):296-303. doi: 10.3109/14764172.2012.738913. Epub 2012 Nov 15.

Reference Type BACKGROUND
PMID: 23057624 (View on PubMed)

Other Identifiers

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2010-021401-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MAF/AGN/Facial/011

Identifier Type: -

Identifier Source: org_study_id

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