The Treatment of Glabellar Frown Lines

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to show that two FDA-approved botulinum toxin drugs called Xeomin® and Botox® can reduce the severity of vertical lines (wrinkles) that appear between the eyebrows (glabellar frown lines).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merz North America, Inc.; Merz Pharmaceuticals, LLC
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Outpatient females 18 to 50 years of age

• Moderate to severe glabellar frown lines

Exclusion Criteria:

• Glabellar Frown Lines at rest rating 3 on the 4-point Facial Wrinkle Scale

• Previous treatment with botulinum toxin

• Previous treatment with biodegradable fillers in glabellar area within last 12 months

• Any severe or uncontrolled systemic disease, malignant tumor, or medical history of HIV infection

• Known hypersensitivity to incobotulinumtoxinA or onabotulinumtoxinA or to any of their excipients

• Intake of any of the forbidden concomitant medication or other agents that might interfere with neuromuscular function or might interfere with the action of botulinum toxin type within 14 days prior to injection