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

October 25, 2011 updated by: Merz Pharmaceuticals GmbH

A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Open-label Extension Period to Investigate the Efficacy and Safety of IncobotulinumtoxinA (Xeomin), Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, IncobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study investigated the efficacy and safety of IncobotulinumtoxinA (Xeomin) in the treatment of glabellar frown lines compared to placebo. The study consisted of a Main Period and an Open-Label Extension [OLEX] Period of 120 days each.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60318
        • Merz Pharmaceuticals GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

•Moderate to severe glabellar frown lines

Exclusion Criteria:

  • Previous insertion of permanent material in the glabellar area
  • Neuromuscular function disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding to total placebo volume 0.5 mL; mode of administration: intramuscular injection
Drug: Placebo
Experimental: IncobotulinumtoxinA (Xeomin) (20 Units)
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl), 20 units, total volume 0.5 mL, mode of administration: intramuscular injection
Drug: IncobotulinumtoxinA (Xeomin) (20 Units)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator's assessment according to the Facial Wrinkle Scale (FWS)
Time Frame: Day 30
Responder: FWS score of 0 or 1.
Day 30
Patient's global assessment
Time Frame: Day 30
Responder: subjects with a score of at least 2+.
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator's assessment according to FWS
Time Frame: Day 7, 60, 90, and 120
Responder: FWS score of 0 or 1.
Day 7, 60, 90, and 120
Patient's global assessment
Time Frame: Day 7, 60, 90, and 120
Responder: subjects with a score of at least 2+.
Day 7, 60, 90, and 120

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merz Pharmaceuticals GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

February 1, 2007

First Submitted That Met QC Criteria

February 1, 2007

First Posted (Estimate)

February 2, 2007

Study Record Updates

Last Update Posted (Estimate)

October 26, 2011

Last Update Submitted That Met QC Criteria

October 25, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRZ 60201-0520/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glabellar Frown Lines

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe