Efficacy and Safety of NT 201 in the Treatment of Lateral Periorbital Wrinkles

Merz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Lateral Periorbital Wrinkles

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00541723

2006-005396-17 (EudraCT Number)

MRZ 60201-0617/1

Details and patient eligibility

About

To investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in comparison to placebo in the treatment of moderate to severe lateral periorbital wrinkles at maximum smile and to compare two different application schemes of Xeomin. Each subject will be treated on the right and left eye area, using the same dose but different application schemes (i.e. 3 or 4 injection sites).

Full description

Conducted in Europe

Enrollment: 111 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Moderate (grade 2) to severe (grade 3) symmetrical lateral periorbital wrinkles assessed by the investigator according to the 4-point scale at maximum smile

Main Exclusion Criteria:

• Significant facial asymmetry

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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111 participants in 4 patient groups, including a placebo group

IncobutolinumtoxinA (Xeomin), 4-injection scheme

Experimental group

Description:

IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150kD), free of complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free of complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl); total volume 0.24 mL per side, i.e. 4 x 0.06 mL (4 x 3 units = 12 units); mode of administration: intramuscular injection.

Treatment:

Drug: IncobotulinumtoxinA (Xeomin)

Placebo 4-injection scheme

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; total volume 0.24 mL per side, i.e. 4 x 0.06 mL placebo solution; mode of administration: intramuscular injection.

Treatment:

Drug: Placebo

IncobotulinumtoxinA (Xeomin), 3-injection scheme

Experimental group

Description:

IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150kD), free of complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free of complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl); total volume 0.24 mL per side, i.e. 3 x 0.08 mL (3 x 4 units = 12 units); Mode of administration: intramuscular injection.

Treatment:

Drug: IncobotulinumtoxinA (Xeomin)

Placebo 3-injection Scheme

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; total volume 0.24 mL per side, i.e. 3 x 0.08 mL placebo solution; mode of administration: intramuscular injection.

Treatment:

Drug: Placebo