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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
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Drug: NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®)) Drug: OnabotulinumtoxinA (Vistabel®) Phase 3

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: IncobotulinumtoxinA (Xeomin®/Bocouture®)
IncobotulinumtoxinA (Xeomin®/Bocouture®), 24 units; mode of administration: intramuscular injection.
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.
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:
  • "BOTOX® Cosmetic"
  • "Botulinum toxin type A (900 kiloDalton)"




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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
Criteria

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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
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Study Director: Medical Expert Merz Pharmaceuticals GmbH
Publications of Results:
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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
Additional relevant MeSH terms:
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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