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

NCT ID: NCT00777803

Last Updated: 2012-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 381 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-05-31

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.

Conditions

Glabellar Frown Lines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IncobotulinumtoxinA (Xeomin®/Bocouture®)

IncobotulinumtoxinA (Xeomin®/Bocouture®), 24 units; mode of administration: intramuscular injection.

Group Type: EXPERIMENTAL

NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®))

Intervention Type: DRUG

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.

OnabotulinumtoxinA (Vistabel®)

OnabotulinumtoxinA (Vistabel®), 24 units; mode of administration: intramuscular injection.

Group Type: ACTIVE_COMPARATOR

OnabotulinumtoxinA (Vistabel®)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

"Botulinum toxin type A (150 kiloDalton), free from complexing proteins"; "BOTOX® Cosmetic"; "Botulinum toxin type A (900 kiloDalton)"

Eligibility Criteria

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'.

Exclusion Criteria

• Marked facial asymmetry.
• Ptosis of eyelid and/or eyebrow.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merz Pharmaceuticals GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Expert

Role: STUDY_DIRECTOR

Merz Pharmaceuticals GmbH

Locations

Baden, , Austria

Krems, , Austria

Salzburg, , Austria

Vienna, , Austria

Bad Soden, , Germany

Böblingen, , Germany

Cologne, , Germany

Darmstadt, , Germany

Frankfurt, , Germany

Korschenbroich, , Germany

Ludwigshafen, , Germany

Munich, , Germany

Wuppertal, , Germany

Glasgow, , United Kingdom

Manchester, , United Kingdom

Suttion Coldfield, , United Kingdom

Winchester, , United Kingdom

Countries

Austria; Germany; United Kingdom

References

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.

Reference Type: RESULT

PMID: 21134045 (View on PubMed)

Other Identifiers

2008-002713-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MRZ 60201 GL_3002

Identifier Type: -

Identifier Source: org_study_id