NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines (Head2Head)

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

Study Description

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

Study Design

• 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

Arms and Interventions

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)"

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Study Director: Medical Expert; Merz Pharmaceuticals GmbH

More Information

Publications of Results:

Sattler G, Callander MJ, Grablowitz D, Walker T, Bee EK, Rzany B, Flynn TC, Carruthers A. Noninferiority of incobotulinumtoxinA, free from complexing proteins, compared with another botulinum toxin type A in the treatment of glabellar frown lines. Dermatol Surg. 2010 Dec;36 Suppl 4:2146-54. doi: 10.1111/j.1524-4725.2010.01706.x.

• 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
• Results First Posted: February 10, 2012
• Last Update Posted: March 8, 2012
• Last Verified: March 2012

Additional relevant MeSH terms:

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