The Treatment of Glabellar Frown Lines
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Merz North America, Inc.
- Enrollment
- 250
- Locations
- 10
- Primary Endpoint
- Efficacy, Measured as the Percentage of Participants Who Responded to Treatment
Study Overview
Brief 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).
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
IncobotulinumtoxinA
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points
Intervention: IncobotulinumtoxinA (Drug)
OnabotulinumtoxinA
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points
Intervention: OnabotulinumtoxinA (Drug)
Outcomes
Primary Outcomes
Efficacy, Measured as the Percentage of Participants Who Responded to Treatment
Time Frame: 1 Month from baseline
Response defined as ≥ 1 point improvement from baseline (prior to treatment) on the Facial Wrinkle Scale at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 1 month from treatment.
Secondary Outcomes
- Response at Maximum Frown Rated by Independent Rater(4 months from baseline)
- Response at Maximum Frown Rated by Treating Physician(4 months from baseline)
- Subject Satisfaction(4 months from baseline)
- Subject Perception of Treatment Onset(Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.)
- Subject Perception of Treatment Peak Effect(Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.)