Comparative Study of the Effect of Dysport and Botox

Phase 4CompletedNCT00434863

Laserklinik Karlsruhe24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Aging

Interventions

botulinum toxin type ADRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Laserklinik Karlsruhe

Karlsruhe, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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