Comparative Study of the Effect of Dysport and Botox

Condition(s) targeted: Aging

Intervention: botulinum toxin type A (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Laserklinik Karlsruhe

Official(s) and/or principal investigator(s):
Syrus Karsai, MD, Principal Investigator, Affiliation: Laserklinik Karlsruhe

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

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

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

Minimum age: 30 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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)

Laserklinik Karlsruhe, Karlsruhe, BW 76133, Germany

Starting date: October 2005
Ending date: March 2006
Last updated: February 12, 2007