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

Allergan

Status and phase: Completed; Phase 4

Conditions: Glabellar Lines

Treatments: Biological: botulinum toxin type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01271452

MAF/AGN/Facial/011

2010-021401-20 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 224 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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224 participants in 2 patient groups

Vistabel®

Active Comparator group

Description:

botulinum toxin type A (Vistabel®)

Treatment:

Biological: botulinum toxin type A

Biological: botulinum toxin type A

Bocouture®

Active Comparator group

Description:

botulinum toxin type A (Bocouture®)

Treatment:

Biological: botulinum toxin type A

Biological: botulinum toxin type A