this study was proposed to provide more scientific and objective data on the clinical and aesthetic effects of these two toxins (Dysport and Xeomin).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Brazilian Center For Studies in Dermatology
Porto Alegre, Rio Grande do Sul, Brazil
Percentage of Responders After 5 Months After the Procedure
Percentage (%) of responders, after 5 months of injection, to the effects of two botulinum toxin type A (BT-A), Dysport® and Xeomin®. Responders were defined as individuals who presented at least 1 score less in the Wrinkles Scale Score (WSS) at maximum contraction compared to the WSS score at baseline. WSS is a validated 4-point scale, at rest and at maximum voluntary contraction of the frontalis muscle, in which 0 means no wrinkles up to 3 which means sever wrinkles.
Time frame: 5 months after intervention
Maximum Evoked Compound Muscle Action Potential
To evaluate the duration, magnitude and peak of effects of two BT-A preparations, by measuring of the maximum Evoked Compound Muscle Action Potentials after contraction.
Time frame: 5 months after the procedure.
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