Comparative Study of the Effect of Dysport and Botox

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434863
• Other study ID #: CR-015-LK/2005
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2007
• Last updated: February 12, 2007
• Start date: October 2005
• Est. completion date: March 2006

Study information

• Verified date: February 2007
• Source: Laserklinik Karlsruhe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging

Intervention

Drug:
• botulinum toxin type A

Locations

Country	Name	City	State
Germany	Laserklinik Karlsruhe	Karlsruhe	BW

Sponsors (1)

Lead Sponsor	Collaborator
Laserklinik Karlsruhe

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Side Effects upon completion of the study (20 weeks after injection)