NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines (Head2Head)
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ClinicalTrials.gov Identifier: NCT00777803 |
Recruitment Status :
Completed
First Posted : October 22, 2008
Results First Posted : February 10, 2012
Last Update Posted : March 8, 2012
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Condition or disease | Intervention/treatment | Phase |
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Glabellar Frown Lines | Drug: NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®)) Drug: OnabotulinumtoxinA (Vistabel®) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 381 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | April 2009 |
Actual Study Completion Date : | May 2009 |
Arm | Intervention/treatment |
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Experimental: IncobotulinumtoxinA (Xeomin®/Bocouture®)
IncobotulinumtoxinA (Xeomin®/Bocouture®), 24 units; mode of administration: intramuscular injection.
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Drug: NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®))
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.
Other Name: "Botulinum toxin type A (150 kiloDalton), free from complexing proteins" |
Active Comparator: OnabotulinumtoxinA (Vistabel®)
OnabotulinumtoxinA (Vistabel®), 24 units; mode of administration: intramuscular injection.
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Drug: OnabotulinumtoxinA (Vistabel®)
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.
Other Names:
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- Responder by Independent Rater's Assessment at Maximum Frown at Week 4 [ Time Frame: 4 weeks after injection ]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.
- Responder by Independent Rater's Assessment at Maximum Frown at Week 12 [ Time Frame: 12 weeks after injection ]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.
- Responder by Independent Rater's Assessment at Rest at Week 4 [ Time Frame: 4 weeks after injection ]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.
- Responder by Independent Rater's Assessment at Rest at Week 12 [ Time Frame: 12 weeks after injection ]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.
- Responder by Investigator's Assessment at Maximum Frown at Week 4 [ Time Frame: 4 weeks after injection ]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.
- Responder by Investigator's Assessment at Maximum Frown at Week 12 [ Time Frame: 12 weeks after injection ]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.
- Responder by Investigator's Assessment at Rest at Week 4 [ Time Frame: 4 weeks after injection ]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.
- Responder by Investigator's Assessment at Rest at Week 12 [ Time Frame: 12 weeks after injection ]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.
- Responder by Patient's Assessment at Maximum Frown at Week 4 [ Time Frame: 4 weeks after injection ]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.
- Responder by Patient's Assessment at Maximum Frown at Week 12 [ Time Frame: 12 weeks after injection ]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.
- Responder by Patient's Assessment at Rest at Week 4 [ Time Frame: 4 weeks after injection ]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.
- Response by Patient's Assessment at Rest at Week 12 [ Time Frame: 12 weeks after injection ]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.
- Responder by Patient's Global Assessment at Week 4 [ Time Frame: 4 weeks after injection ]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.
- Responder by Patient's Global Assessment at Week 12 [ Time Frame: 12 weeks after injection ]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.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777803
Austria | |
Baden, Austria | |
Krems, Austria | |
Salzburg, Austria | |
Vienna, Austria | |
Germany | |
Bad Soden, Germany | |
Boeblingen, Germany | |
Cologne, Germany | |
Darmstadt, Germany | |
Frankfurt, Germany | |
Korschenbroich, Germany | |
Ludwigshafen, Germany | |
Munich, Germany | |
Wuppertal, Germany | |
United Kingdom | |
Glasgow, United Kingdom | |
Manchester, United Kingdom | |
Suttion Coldfield, United Kingdom | |
Winchester, United Kingdom |
Study Director: | Medical Expert | Merz Pharmaceuticals GmbH |
Responsible Party: | Merz Pharmaceuticals GmbH |
ClinicalTrials.gov Identifier: | NCT00777803 |
Other Study ID Numbers: |
MRZ 60201 GL_3002 2008-002713-40 ( EudraCT Number ) |
First Posted: | October 22, 2008 Key Record Dates |
Results First Posted: | February 10, 2012 |
Last Update Posted: | March 8, 2012 |
Last Verified: | March 2012 |
Botulinum Toxins Botulinum Toxins, Type A abobotulinumtoxinA incobotulinumtoxinA Acetylcholine Release Inhibitors Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents |