Comparative Study of the Effect of Dysport and Botox

NCT ID: NCT00434863

Last Updated: 2007-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

botulinum toxin type A

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Laserklinik Karlsruhe

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Syrus Karsai, MD

Role: PRINCIPAL_INVESTIGATOR

Laserklinik Karlsruhe

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Laserklinik Karlsruhe

Karlsruhe, Baden-Wurttemberg, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CR-015-LK/2005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dysport® Adult Upper Limb Spasticity
NCT01313299 COMPLETED PHASE3