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

Allergan0 sites224 target enrollmentSeptember 2010

ConditionsGlabellar Lines

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Glabellar Lines
Sponsor: Allergan
Enrollment: 224
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)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

April 2011

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

Time Frame: 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 Outcomes

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 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 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 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 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 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 28 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS(Day 28)