The Treatment of Glabellar Frown Lines

Study Overview
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Brief Summary
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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
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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.

Conditions
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Glabellar Frown Lines

Intervention / Treatment
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* Drug: IncobotulinumtoxinA
* Drug: OnabotulinumtoxinA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IncobotulinumtoxinA<br>20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points | Drug: IncobotulinumtoxinA<br>* 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection<br>* Other names: Botulinum toxin type A [150 kDa], free from complexing proteins;|
| Active Comparator: OnabotulinumtoxinA<br>20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points | Drug: OnabotulinumtoxinA<br>* 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection<br>* Other names: Botox®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 Month from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 4 months from baseline | 
| Subject Perception of Treatment Onset | Assessment of subject perception of date of treatment onset using a take-home diary | 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 | Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frown Lines, Glabellar Frown Lines, Facial Wrinkles