Conditions: Sun-induced Wrinkles
Keywords: botulinum toxin, wrinkles
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 80
Healthy volunteers: yes

Brief 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).

Arms:
arm 1: 30 U of Dysport® was injected on the right side of the forehead and 12 U Xeomin® was injected on the left side of the forehead (dose-equivalence 2.5:1). arm 2: 30 U Dysport® was injected on the left side of the forehead and 12 U Xeomin® was injected on the right side of the forehead (dose-equivalence 2.5:1).

Interventions: intervention 1: Dysport intervention 2: Xeomin
Intervention descriptions: intervention 1: Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead. intervention 2: Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead

Protocol document: