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Completed

NCT Number: NCT00434863

Comparative Study of the Effect of Dysport and Botox

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

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Key information

Conditions

Aging

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Laserklinik Karlsruhe

Karlsruhe, Baden-Wurttemberg, 76133, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Botulinum Toxin Type A

Drug

Primary outcomes

  1. 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

  2. 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 outcomes

  1. Side Effects upon completion of the study (20 weeks after injection)

Sponsors and collaborators

Lead sponsor

Laserklinik Karlsruhe

Other

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Feb 13, 2007
Registry last updated
Feb 13, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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