To investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in comparison to placebo in the treatment of moderate to severe lateral periorbital wrinkles at maximum smile and to compare two different application schemes of Xeomin. Each subject will be treated on the right and left eye area, using the same dose but different application schemes (i.e. 3 or 4 injection sites).
Conducted in Europe
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
111
Intramuscular injection at day 0, at 3 and 4 injection sites per eye (4 x 3 or 3 x 4 units = 12 units per eye)
Intramuscular injection at day 0, at 3 and 4 injection sites per eye.
Unnamed facility
Cannes, France
Unnamed facility
Nice, France
Unnamed facility
Paris, France
Unnamed facility
Düsseldorf, Germany
Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline.
Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.
Time frame: Week 4
Response assessed by the investigator at maximum smile for either eye area compared to baseline.
Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.
Time frame: Weeks 2, 4, 12, and 20
Response assessed by the subject's global assessment at maximum smile for either eye area compared to baseline.
Responder: subjects with at least a moderate improvement, i.e. a score of at least +2 on a 9 point Likert scale.
Time frame: Weeks 2, 4, 12, and 20
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Unnamed facility
Karlsruhe, Germany
Unnamed facility
Munich, Germany
Unnamed facility
Starnberg, Germany
Unnamed facility
Roma, Italy
Unnamed facility
Bexley. Kent, United Kingdom
Unnamed facility
Glasgow, United Kingdom
...and 2 more locations