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Comparative Study of the Effect of Dysport and Botox

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00434863
First Posted: February 13, 2007
Last Update Posted: February 13, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Laserklinik Karlsruhe
  Purpose
The purpose of this study is to test the effect of Dysport and Botox on forehead wrinkles and EMG activity.

Condition Intervention Phase
Aging Drug: botulinum toxin type A Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Comparative Randomized Double-Blinded Study of the Effect of Dysport and Botox on Forehead Wrinkles and EMG Activity

Resource links provided by NLM:


Further study details as provided by Laserklinik Karlsruhe:

Primary Outcome Measures:
  • 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:
  • Side Effects upon completion of the study (20 weeks after injection)

Estimated Enrollment: 24
Study Start Date: October 2005
Estimated Study Completion Date: March 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434863


Locations
Germany
Laserklinik Karlsruhe
Karlsruhe, BW, Germany, 76133
Sponsors and Collaborators
Laserklinik Karlsruhe
Investigators
Principal Investigator: Syrus Karsai, MD Laserklinik Karlsruhe
  More Information

ClinicalTrials.gov Identifier: NCT00434863     History of Changes
Other Study ID Numbers: CR-015-LK/2005
First Submitted: February 12, 2007
First Posted: February 13, 2007
Last Update Posted: February 13, 2007
Last Verified: February 2007

Keywords provided by Laserklinik Karlsruhe:
botulinum toxin type A
Dysport®
Botox®
hyperfunctional forehead lines
randomized controlled trial
double-blinded trial
electromyogram (EMG)

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
onabotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents