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

NCT00541723 | Completed Phase 3

• 2 other identifiers: MRZ 60201-0617/12006-005396-17
• Study Type: interventional
• Target: 111
• Locations: 4 countries
• Sites: 12

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).

Conditions

Lateral Periorbital Wrinkles

Outcome Measures

Primary Outcomes (1)

• Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline.

  Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.

  Week 4

Secondary Outcomes (2)

• Response assessed by the investigator at maximum smile for either eye area compared to baseline.

  Weeks 2, 4, 12, and 20

• Response assessed by the subject's global assessment at maximum smile for either eye area compared to baseline.

  Weeks 2, 4, 12, and 20

Study Arms (4)

IncobutolinumtoxinA (Xeomin), 4-injection scheme

EXPERIMENTAL

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.

Drug: IncobotulinumtoxinA (Xeomin)

Placebo 4-injection scheme

PLACEBO COMPARATOR

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.

Drug: Placebo

IncobotulinumtoxinA (Xeomin), 3-injection scheme

EXPERIMENTAL

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.

Drug: IncobotulinumtoxinA (Xeomin)

Placebo 3-injection Scheme

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

IncobotulinumtoxinA (Xeomin) DRUG

Intramuscular injection at day 0, at 3 and 4 injection sites per eye (4 x 3 or 3 x 4 units = 12 units per eye)

IncobotulinumtoxinA (Xeomin), 3-injection scheme; IncobutolinumtoxinA (Xeomin), 4-injection scheme

Placebo DRUG

Intramuscular injection at day 0, at 3 and 4 injection sites per eye.

Placebo 3-injection Scheme; Placebo 4-injection scheme

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- Significant facial asymmetry

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (12)

Unknown Facility

Cannes, France

Location

Unknown Facility

Nice, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Düsseldorf, Germany

Location

Unknown Facility

Karlsruhe, Germany

Location

Unknown Facility

Munich, Germany

Location

Unknown Facility

Starnberg, Germany

Location

Unknown Facility

Roma, Italy

Location

Unknown Facility

Bexley. Kent, United Kingdom

Location

Unknown Facility

Glasgow, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Sutton Coldfield, United Kingdom

Location

MeSH Terms

Interventions

incobotulinumtoxinA

Study Officials

• David Eccleston, MD

  MediZen, Sutton Coldfield, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2007
• First Posted: October 10, 2007
• Study Start: September 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: May 1, 2008
• Last Updated: March 8, 2012

Record last verified: 2012-03

Locations

FR (3); IT (1); GB (4); DE (4)