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IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines

NCT00770211 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2011-10-07

Study results available
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Summary

The study objective is to show the superior efficacy of IncobotulinumtoxinA (Xeomin) over placebo by evaluation of treatment success analyzing the investigator's rating on the Facial Wrinkle Scale and the patient's assessment on a 4-point scale. 255 female and male patients with moderate to severe glabellar frown lines will be randomized in a 2:1 ratio to receive one injection of IncobotulinumtoxinA (Xeomin) or placebo and will be followed up until day 120.

Conditions

  • Moderate to Severe Glabellar Frown Lines

Interventions

DRUG

IncobotulinumtoxinA (Xeomin) (20 Units)

The treatment will be administered only once at day 0 at five injection sites in the glabellar area. The total dose of 20 Units IncobotulinumtoxinA (Xeomin) is reconstituted in a total injection volume of 0.5 mL that is to be injected to the five sites in equal aliquots of 0.1 mL.

DRUG

Placebo

The treatment will be administered only once at day 0 at five injection sites in the glabellar area. Volume of Placebo equivalent to IncobotulinumtoxinA (Xeomin).

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • William Hanke, MD

  • Rhoda Narins, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-03-31
Completion
2009-06-30

Countries

  • United States

Study Locations

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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 NCT00770211 on ClinicalTrials.gov