Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines

Merz Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Glabellar Frown Lines

Treatments: Drug: Botulinum neurotoxin type A, free of complexing proteins; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00430586

MRZ 60201-0527/1

Details and patient eligibility

About

NT 201 is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, NT 201 causes local weakening to full paralysis depending on the administered dose. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study will determine the optimal dose of NT 201 in the treatment of glabellar frown lines.

Enrollment: 191 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe glabellar frown lines

Exclusion criteria

• Previous insertion of permanent material in the glabellar area
• Neuromuscular function disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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191 participants in 4 patient groups, including a placebo group

20 U NT 201

Experimental group

Treatment:

Drug: Botulinum neurotoxin type A, free of complexing proteins

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

10 U NT 201

Experimental group

Treatment:

Drug: Botulinum neurotoxin type A, free of complexing proteins

30 U NT 201

Experimental group

Treatment:

Drug: Botulinum neurotoxin type A, free of complexing proteins