IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines

Merz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Glabellar Frown Lines

Treatments: Drug: Placebo; Drug: IncobotulinumtoxinA (Xeomin) (20 Units)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00430963

MRZ 60201-0520/1

Details and patient eligibility

About

IncobotulinumtoxinA (Xeomin) 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, IncobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study investigated the efficacy and safety of IncobotulinumtoxinA (Xeomin) in the treatment of glabellar frown lines compared to placebo. The study consisted of a Main Period and an Open-Label Extension [OLEX] Period of 120 days each.

Enrollment: 256 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: Double Blind

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256 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding to total placebo volume 0.5 mL; mode of administration: intramuscular injection

Treatment:

Drug: Placebo

IncobotulinumtoxinA (Xeomin) (20 Units)

Experimental group

Description:

IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl), 20 units, total volume 0.5 mL, mode of administration: intramuscular injection

Treatment:

Drug: IncobotulinumtoxinA (Xeomin) (20 Units)