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

Merz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Glabellar Frown Lines

Treatments: Drug: NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®)); Drug: OnabotulinumtoxinA (Vistabel®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00777803

MRZ 60201 GL_3002

2008-002713-40 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 381 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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381 participants in 2 patient groups

IncobotulinumtoxinA (Xeomin®/Bocouture®)

Experimental group

Description:

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

Treatment:

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

OnabotulinumtoxinA (Vistabel®)

Active Comparator group

Description:

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

Treatment:

Drug: OnabotulinumtoxinA (Vistabel®)