NCT01728337

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Hexsel Dermatology Clinic · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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).

Detailed 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).

Conditions

• Sun-induced Wrinkles

Interventions

Type	Name	Description
DRUG	Dysport	Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
DRUG	Xeomin	Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-11-19
• Last updated: 2019-07-26
• Results posted: 2014-08-11

Locations

1 site across 1 country: Brazil