NCT00434863

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed
Last Updated

February 13, 2007

Status Verified

February 1, 2007

First QC Date

February 12, 2007

Last Update Submit

February 12, 2007

Conditions

Aging

Keywords

botulinum toxin type ADysport®Botox®hyperfunctional forehead linesrandomized controlled trialdouble-blinded trialelectromyogram (EMG)

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

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

Interventions

botulinum toxin type ADRUG

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laserklinik Karlsruhe

Karlsruhe, Baden-Wurttemberg, 76133, Germany

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Syrus Karsai, MD

    Laserklinik Karlsruhe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2007

First Posted

February 13, 2007

Study Start

October 1, 2005

Study Completion

March 1, 2006

Last Updated

February 13, 2007

Record last verified: 2007-02

Locations

DE(1)