MedTrace Logo

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

NCT00541723 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2012-03-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • David Eccleston, MD · MediZen, Sutton Coldfield, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-02-29
Completion
2008-05-31

Countries

  • France
  • Germany
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00541723 on ClinicalTrials.gov