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CompletedNCT00434863Updated Feb 13, 2007

Comparative Study of the Effect of Dysport and Botox

A Phase 4 interventional study of botulinum toxin type A in Aging, sponsored by Laserklinik Karlsruhe. Completed at 1 site in Germany. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-02-13.

Sponsored by Laserklinik Karlsruhe · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Aging

Keywords

  • botulinum toxin type A
  • Dysport®
  • Botox®
  • hyperfunctional forehead lines
  • randomized controlled trial
  • double-blinded trial
  • electromyogram (EMG)
03

In context

Lead sponsor

Laserklinik Karlsruhe is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
24 participants

Interventions

  • Drugbotulinum toxin type A
06

What researchers measure

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)

07

Study locations

1 site
  • Laserklinik Karlsruhe
    Karlsruhe, BW 76133, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00434863
Lead sponsor
Laserklinik Karlsruhe
First posted
Feb 13, 2007
Start date
Oct 2005
Completion
Mar 2006
Last update
Feb 13, 2007

Study contacts

Syrus Karsai, MD
principal investigator · Laserklinik Karlsruhe
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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