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
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View full resultsBasic Information
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COMPLETED
PHASE4
224 participants
INTERVENTIONAL
2010-09-30
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vistabel®
botulinum toxin type A (Vistabel®)
botulinum toxin type A
20 units (total dose) botulinum toxin type A injected into glabellar region on Day 0
Bocouture®
botulinum toxin type A (Bocouture®)
botulinum toxin type A
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
botulinum toxin type A
30 units (total dose) botulinum toxin type A injected into glabellar region on Day 0
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Munich, Bavaria, Germany
Countries
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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.
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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