The Treatment of Glabellar Frown Lines
Status and phase
Completed
Phase 4
Conditions
Glabellar Frown Lines
Treatments
Drug: IncobotulinumtoxinA
Drug: OnabotulinumtoxinA
Details and patient eligibility
About
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).
Full description
This is a prospective, multicenter, randomized, double-blind, parallel group clinical study to investigate the equivalence of incobotulinumtoxinA (Xeomin®) to onabotulinumtoxinA (Botox®) in the treatment of glabellar frown lines.
Enrollment
250 patients
Sex
Female
Ages
18 to 50 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
250 participants in 2 patient groups
IncobotulinumtoxinA
Experimental group
Description:
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points
Treatment:
Drug: IncobotulinumtoxinA
OnabotulinumtoxinA
Active Comparator group
Description:
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points
Treatment:
Drug: OnabotulinumtoxinA
Trial contacts and locations
10
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Data sourced from clinicaltrials.gov
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