IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, IncobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study investigated the efficacy and safety of IncobotulinumtoxinA (Xeomin) in the treatment of glabellar frown lines compared to placebo. The study consisted of a Main Period and an Open-Label Extension \[OLEX\] Period of 120 days each.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
256
Merz Pharmaceuticals GmbH
Frankfurt, Germany
Investigator's assessment according to the Facial Wrinkle Scale (FWS)
Responder: FWS score of 0 or 1.
Time frame: Day 30
Patient's global assessment
Responder: subjects with a score of at least 2+.
Time frame: Day 30
Investigator's assessment according to FWS
Responder: FWS score of 0 or 1.
Time frame: Day 7, 60, 90, and 120
Patient's global assessment
Responder: subjects with a score of at least 2+.
Time frame: Day 7, 60, 90, and 120
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