Phase IV Study On Muscle Activity Of Two Commercial Preparations Of Botulinum

Sun-induced Wrinkles Clinical Trial

Official title: Phase IV, Randomized, Double-blind Study on Muscle Activity of Two Commercial Preparations of Botulinum Toxin Type A (Dysport and Xeomin) Administered to the Upper Third of the Face (Forehead Lines).

Status Completed

Clinical Trial Summary

this study was proposed to provide more scientific and objective data on the clinical and aesthetic effects of these two toxins (Dysport and Xeomin).

Clinical Trial Description

Subjects will perform 6 (six) visits during the study:

Screening visit, performed 30 to 1 day before the visit 1, when eligible subjects will be recruited and first evaluations will be performed; visit 1, which is the baseline and when the injections will be performed; visit 2, 30 +/- 3 days after the injections, when evaluations will be performed; visit 3, 90 +/- 3 days after the injections, when evaluations will be performed; 4, 120 +/- 3 days after the injections, when evaluations will be performed; visit 5, 150 +/- 3 days after the injections, when evaluations will be performed.

Assessment of percentage (%) of responders, after 5 months of injection, to the effects of two BT-A preparations, Dysport® and Xeomin®, by measuring frontalis m. wrinkle intensity at maximum contraction, as measured by visual Wrinkles Severity Scale (WSS). ;

Related Conditions & MeSH terms

• Sun-induced Wrinkles

• NCT number: NCT01728337
• Study type: Interventional
• Source: Brazilan Center for Studies in Dermatology
• Status: Completed
• Phase: Phase 4
• Start date: July 2011
• Completion date: February 2012