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

Phase 3

Completed

• Conditions: Lateral Periorbital Wrinkles
• Interventions: Drug: IncobotulinumtoxinA (Xeomin); Drug: Placebo

• Registration Number: NCT00541723
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

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).

Detailed Description

Conducted in Europe

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-08
• Study First Submitted QC: 2007-10-08
• Study First Posted: 2007-10-10
• Primary Completion: 2008-02
• Study Completion: 2008-05
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Read More

Exclusion Criteria

• Significant facial asymmetry

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IncobutolinumtoxinA (Xeomin), 4-injection scheme	IncobotulinumtoxinA (Xeomin)	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.
Placebo 4-injection scheme	Placebo	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.
IncobotulinumtoxinA (Xeomin), 3-injection scheme	IncobotulinumtoxinA (Xeomin)	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.
Placebo 3-injection Scheme	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline.	Week 4	Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.

Secondary Outcome Measures

Name	Time	Method
Response assessed by the investigator at maximum smile for either eye area compared to baseline.	Weeks 2, 4, 12, and 20	Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.
Response assessed by the subject's global assessment at maximum smile for either eye area compared to baseline.	Weeks 2, 4, 12, and 20	Responder: subjects with at least a moderate improvement, i.e. a score of at least +2 on a 9 point Likert scale.