Comparative Study of the Effect of Dysport and Botox

February 12, 2007 updated by: Laserklinik Karlsruhe

A Comparative Randomized Double-Blinded Study of the Effect of Dysport and Botox on Forehead Wrinkles and EMG Activity

The purpose of this study is to test the effect of Dysport and Botox on forehead wrinkles and EMG activity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

24

Phase

  • Phase 4

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
    • BW
      • Karlsruhe, BW, Germany, 76133
        • Laserklinik Karlsruhe

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

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age between 30 and 70 years
  • moderate to severe hyperfunctional forehead wrinkles at maximum contraction and at rest

Exclusion Criteria:

  • application of botulinum toxin products for a period of 12 months prior to the study
  • any significant health disturbances
  • facial nerve palsy, and any facial conditions that could confound safety or efficacy results
  • pregnancy and breast-feeding
  • neuromuscular diseases
  • drugs interfering with neuromuscular function (e.g. aminoglycosides)

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: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
EMG Muscular Activity at baseline and 0.5, 1, 2, 4, 8 and 10 weeks after injection, followed by weekly examinations for a total observation period of 20 weeks
Frown Wrinkle Severity (photographs and questionnaire) at baseline and 0.5, 1, 2, 4, 8 and 10 weeks after injection, followed by weekly examinations for a total observation period of 20 weeks

Secondary Outcome Measures

Outcome Measure
Side Effects upon completion of the study (20 weeks after injection)

Collaborators and Investigators

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

Sponsor

Laserklinik Karlsruhe

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, 2005

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

February 12, 2007

First Submitted That Met QC Criteria

February 12, 2007

First Posted (Estimate)

February 13, 2007

Study Record Updates

Last Update Posted (Estimate)

February 13, 2007

Last Update Submitted That Met QC Criteria

February 12, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-015-LK/2005

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.

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