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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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 24, 2014