NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines

Study Overview
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Brief Summary
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NT 201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), is a Botulinum toxin type A preparation free of complexing proteins (150 kiloDalton). Injected into the muscle, NT201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is used for aesthetic treatment of mimic wrinkles and in the therapy of neurologic diseases. This study will investigate the safety and efficacy (non-inferiority) of NT 201 in comparison with OnabotulinumtoxinA (Vistabel®) in the treatment of glabellar frown lines.

Official Title
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A Prospective, Multicenter, Randomized, Rater- and Subject-Blind, Parallel Group Trial to Investigate the Non-Inferiority of NT 201, Free of Complexing Proteins, in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines

Conditions
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Glabellar Frown Lines

Intervention / Treatment
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* Drug: NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®))
* Drug: OnabotulinumtoxinA (Vistabel®)


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: • Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on a 4-point facial wrinkle scale) as assessed by the investigator's rating: 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe'. Main Exclusion Criteria: Marked facial asymmetry. Ptosis of eyelid and/or eyebrow.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IncobotulinumtoxinA (Xeomin®/Bocouture®)<br>IncobotulinumtoxinA (Xeomin®/Bocouture®), 24 units; mode of administration: intramuscular injection. | Drug: NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®))<br>* NT201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), active ingredient: Clostridium botulinum neurotoxin type A free from complexing proteins, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.<br>* Other names: Botulinum toxin type A (150 kiloDalton), free from complexing proteins;|
| Active Comparator: OnabotulinumtoxinA (Vistabel®)<br>OnabotulinumtoxinA (Vistabel®), 24 units; mode of administration: intramuscular injection. | Drug: OnabotulinumtoxinA (Vistabel®)<br>* OnabotulinumtoxinA (Vistabel®), active ingredient: Clostridium botulinum neurotoxin type A, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.<br>* Other names: Botulinum toxin type A (900 kiloDalton);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder by Independent Rater's Assessment at Maximum Frown at Week 4 | The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | 4 weeks after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder by Independent Rater's Assessment at Maximum Frown at Week 12 | The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | 12 weeks after injection | 
| Responder by Independent Rater's Assessment at Rest at Week 4 | The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | 4 weeks after injection | 
| Responder by Independent Rater's Assessment at Rest at Week 12 | The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | 12 weeks after injection | 
| Responder by Investigator's Assessment at Maximum Frown at Week 4 | The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | 4 weeks after injection | 
| Responder by Investigator's Assessment at Maximum Frown at Week 12 | The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | 12 weeks after injection | 
| Responder by Investigator's Assessment at Rest at Week 4 | The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | 4 weeks after injection | 
| Responder by Investigator's Assessment at Rest at Week 12 | The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | 12 weeks after injection | 
| Responder by Patient's Assessment at Maximum Frown at Week 4 | The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | 4 weeks after injection | 
| Responder by Patient's Assessment at Maximum Frown at Week 12 | The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | 12 weeks after injection | 
| Responder by Patient's Assessment at Rest at Week 4 | The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | 4 weeks after injection | 
| Response by Patient's Assessment at Rest at Week 12 | The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles. | 12 weeks after injection | 
| Responder by Patient's Global Assessment at Week 4 | The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 4 weeks after treatment rated by the patient. | 4 weeks after injection | 
| Responder by Patient's Global Assessment at Week 12 | The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 12 weeks after treatment rated by the patient. | 12 weeks after injection |