The Treatment of Glabellar Frown Lines
- Conditions
- Glabellar Frown Lines
- Interventions
- Registration Number
- NCT02096081
- Lead Sponsor
- Merz North America, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 250
- Outpatient females 18 to 50 years of age
- Moderate to severe glabellar frown lines
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IncobotulinumtoxinA IncobotulinumtoxinA 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points OnabotulinumtoxinA OnabotulinumtoxinA 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points
- Primary Outcome Measures
Name Time Method Efficacy, Measured as the Percentage of Participants Who Responded to Treatment 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 Outcome Measures
Name Time Method Response at Maximum Frown Rated by Independent Rater 4 months from baseline Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 4 months from baseline.
Response at Maximum Frown Rated by Treating Physician 4 months from baseline Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 4 months from treatment.
Subject Satisfaction 4 months from baseline Assessment of subject treatment satisfaction by subject questionnaire and diary at 4 months from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as "Satisfaction" and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as "Dissatisfaction." Subjects with missing data were categorized as "Missing."
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. Assessment of subject perception of date of treatment onset using a take-home 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. Assessment of subject perception of date of treatment peak effect using a take-home diary
Trial Locations
- Locations (10)
Merz Investigative Site #001300
🇺🇸Sacramento, California, United States
Merz Investigative Site #001099
🇺🇸Los Angeles, California, United States
Merz Investigative Site #001299
🇺🇸Santa Monica, California, United States
Merz Investigative Site #001298
🇺🇸Washington, D.C., District of Columbia, United States
Merz Investigative Site #001170
🇺🇸Washington, D.C., District of Columbia, United States
Merz Investigative Site #001101
🇺🇸Coral Gables, Florida, United States
Merz Investigative Site #001097
🇺🇸Nashville, Tennessee, United States
Merz Investigative Site #001105
🇺🇸Metairie, Louisiana, United States
Merz Investigative Site #001098
🇺🇸Chestnut Hill, Massachusetts, United States
Merz Investigative Site #001297
🇺🇸New York, New York, United States