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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection
Merz Investigative Site #001099
Los Angeles, California, United States
Merz Investigative Site #001300
Sacramento, California, United States
Merz Investigative Site #001299
Santa Monica, California, United States
Efficacy, Measured as the Percentage of Participants Who Responded to Treatment
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.
Time frame: 1 Month from baseline
Response at Maximum Frown Rated by Independent Rater
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 2 months from baseline.
Time frame: 2 months from baseline
Response at Maximum Frown Rated by Independent Rater
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 3 months from baseline.
Time frame: 3 months from baseline
Response at Maximum Frown Rated by Independent Rater
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.
Time frame: 4 months from baseline
Response at Maximum Frown Rated by Treating Physician
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 1 month from treatment.
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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 #001105
Metairie, Louisiana, United States
Merz Investigative Site #001098
Chestnut Hill, Massachusetts, United States
Merz Investigative Site #001297
New York, New York, United States
Merz Investigative Site #001097
Nashville, Tennessee, United States
Time frame: 1 month from baseline
Response at Maximum Frown Rated by Treating Physician
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 2 months from treatment.
Time frame: 2 months from baseline
Response at Maximum Frown Rated by Treating Physician
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 3 months from treatment.
Time frame: 3 months from baseline
Response at Maximum Frown Rated by Treating Physician
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.
Time frame: 4 months from baseline
Subject Satisfaction
Assessment of subject treatment satisfaction by subject questionnaire and diary at 1 month 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."
Time frame: 1 month from baseline
Subject Satisfaction
Assessment of subject treatment satisfaction by subject questionnaire and diary at 2 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."
Time frame: 2 months from baseline
Subject Satisfaction
Assessment of subject treatment satisfaction by subject questionnaire and diary at 3 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."
Time frame: 3 months from baseline
Subject Satisfaction
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."
Time frame: 4 months from baseline
Subject Perception of Treatment Onset
Assessment of subject perception of date of treatment onset using a take-home diary
Time frame: 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
Assessment of subject perception of date of treatment peak effect using a take-home diary
Time frame: Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.