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Comparative Study of the Effect of Dysport and Botox

This study has been completed.
Sponsor:
Information provided by:
Laserklinik Karlsruhe
ClinicalTrials.gov Identifier:
NCT00434863
First received: February 12, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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:

MedlinePlus related topics: Botox
U.S. FDA Resources

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434863

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

No publications provided

ClinicalTrials.gov Identifier: NCT00434863     History of Changes
Other Study ID Numbers: CR-015-LK/2005
Study First Received: February 12, 2007
Last Updated: February 12, 2007
Health Authority: Germany: Ethics Commission

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, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013