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

Phase 4

Completed

• Conditions: Glabellar Lines
• Interventions: Biological: botulinum toxin type A

• Registration Number: NCT01271452
• Lead Sponsor: Allergan

Brief Summary

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

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-01
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-05
• Study First Posted: 2011-01-06
• Study Completion: 2011-04
• Results First Submitted: 2011-12-09
• Results First Submitted QC: 2011-12-09
• Results First Posted: 2012-01-16
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bocouture®	botulinum toxin type A	botulinum toxin type A (Bocouture®)
Vistabel®	botulinum toxin type A	botulinum toxin type A (Vistabel®)

Primary Outcome Measures

Name	Time	Method
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)	Day 28	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 FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.

Secondary Outcome Measures

Name	Time	Method
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	Day 84	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. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.
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	Day 98	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. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.
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	Day 112	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. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.
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	Day 112	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. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.
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	Day 98	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. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.
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	Day 84	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. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.
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	Day 28	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. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.