Comparative Study of the Effect of Dysport and Botox

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00434863

Enrollment

Registered

2007-02-13

Start date

2005-10-31

Completion date

2006-03-31

Last updated

2007-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

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

Brief summary

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

Interventions

DRUGbotulinum toxin type A

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

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

* 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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Side Effects upon completion of the study (20 weeks after injection)	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026