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Completed

NCT Number: NCT00541723

Efficacy and Safety 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).

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Key information

Conditions

Lateral Periorbital Wrinkles

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cannes, France

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About this study

Conducted in Europe

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Placebo

Drug

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

Primary outcomes

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

    Time frame: Week 4

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

Secondary outcomes

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

    Time frame: Weeks 2, 4, 12, and 20

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

  2. 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

    Responder: subjects with at least a moderate improvement, i.e. a score of at least +2 on a 9 point Likert scale.

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 10, 2007
Registry last updated
Mar 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.