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Vistabel vs Bocouture for Glabellar Lines
NCT01271452Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2010
- Primary completion
- Jan 2011
- Countries
- 1
- Sponsor
- Allergan
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- glabellar lines
01
Overview
Phase 4, randomised, double-blind trial of botulinum toxin type A in glabellar lines (2 arms), sponsored by Allergan. Primary endpoint: Number of Subjects With a Treatment Response at Day 28 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the Facial Wrinkle Scale (FWS). Started Sep 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Vistabel
20 units botulinum toxin type A (Vistabel)
Bocouture
30 units botulinum toxin type A (Bocouture)
03
Who it enrols
Patients with moderate to severe glabellar frown lines, excluding those with neuromuscular disorders (myasthenia gravis, Eaton Lambert), recent botulinum toxin treatment, or bleeding disorders.
04
Endpoints
Primary
Number of Subjects With a Treatment Response at Day 28 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the Facial Wrinkle Scale (FWS)
Secondary
Number of Subjects With a Treatment Response at Day 84 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS
Number of Subjects With a Treatment Response at Day 98 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS
Number of Subjects With a Treatment Response at Day 112 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS
Number of Subjects With a Treatment Response at Day 28 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS
Number of Subjects With a Treatment Response at Day 84 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS
Number of Subjects With a Treatment Response at Day 98 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS
Number of Subjects With a Treatment Response at Day 112 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS
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