Comparative Study of the Effect of Dysport and Botox

Phase 4

Completed

• Conditions: Aging

• Registration Number: NCT00434863
• Lead Sponsor: Laserklinik Karlsruhe

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study Completion: 2006-03
• Status Verified: 2007-02
• Study First Submitted: 2007-02-12
• Study First Submitted QC: 2007-02-12
• Last Update Submitted: 2007-02-12
• Study First Posted: 2007-02-13
• Last Update Posted: 2007-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Measures

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

Trial Locations

Locations (1)

Laserklinik Karlsruhe; 🇩🇪 Karlsruhe, BW, Germany