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

October 8, 2007
March 7, 2012
September 2007
February 2008   (final data collection date for primary outcome measure)
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.
Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline.
Complete list of historical versions of study NCT00541723 on ClinicalTrials.gov Archive Site
  • 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.
Response assessed by the investigator at maximum smile for either eye area compared to baseline. Response assessed by the subject's global assessment at maximum smile for either eye area compared to baseline.
Not Provided
Not Provided
 
Efficacy and Safety of NT 201 in the Treatment of Lateral Periorbital Wrinkles
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

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).

Conducted in Europe

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lateral Periorbital Wrinkles
  • 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)
  • Drug: Placebo
    Intramuscular injection at day 0, at 3 and 4 injection sites per eye.
  • 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.

    Intervention: Drug: IncobotulinumtoxinA (Xeomin)
  • 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.
    Intervention: Drug: Placebo
  • 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.

    Intervention: Drug: IncobotulinumtoxinA (Xeomin)
  • 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
May 2008
February 2008   (final data collection date for primary outcome measure)

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

Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   United Kingdom
 
NCT00541723
MRZ 60201-0617/1, 2006-005396-17
No
Merz Pharmaceuticals GmbH
Merz Pharmaceuticals GmbH
Not Provided
Principal Investigator: David Eccleston, MD MediZen, Sutton Coldfield, United Kingdom
Merz Pharmaceuticals GmbH
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP