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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00541723
First received: October 8, 2007
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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).


Condition Intervention Phase
Lateral Periorbital Wrinkles
Drug: IncobotulinumtoxinA (Xeomin)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 in Comparison to Placebo and to Compare Two Different Application Schemes of NT 201 in the Treatment of Lateral Periorbital Wrinkles

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.


Secondary Outcome Measures:
  • Response assessed by the investigator at maximum smile for either eye area compared to baseline. [ Time Frame: Weeks 2, 4, 12, and 20 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Weeks 2, 4, 12, and 20 ] [ Designated as safety issue: No ]
    Responder: subjects with at least a moderate improvement, i.e. a score of at least +2 on a 9 point Likert scale.


Enrollment: 111
Study Start Date: September 2007
Study Completion Date: May 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IncobutolinumtoxinA (Xeomin), 4-injection scheme

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)
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)
Placebo Comparator: Placebo 4-injection scheme
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
Intramuscular injection at day 0, at 3 and 4 injection sites per eye.
Experimental: IncobotulinumtoxinA (Xeomin), 3-injection scheme

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)
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)
Placebo Comparator: Placebo 3-injection Scheme
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
Intramuscular injection at day 0, at 3 and 4 injection sites per eye.

Detailed Description:

Conducted in Europe

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541723

Locations
France
Cannes, France
Nice, France
Paris, France
Germany
Duesseldorf, Germany
Karlsruhe, Germany
Munich, Germany
Starnberg, Germany
Italy
Roma, Italy
United Kingdom
Bexley. Kent, United Kingdom
Glasgow, United Kingdom
London, United Kingdom
Sutton Coldfield, United Kingdom
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Principal Investigator: David Eccleston, MD MediZen, Sutton Coldfield, United Kingdom
  More Information

No publications provided

Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00541723     History of Changes
Other Study ID Numbers: MRZ 60201-0617/1, 2006-005396-17
Study First Received: October 8, 2007
Last Updated: March 7, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014