Glabellar Frown Lines
Conditions
Brief summary
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.
Interventions
DRUGPlacebo
Sponsors
Merz Pharmaceuticals GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
•Moderate to severe glabellar frown lines
Exclusion criteria
* Previous insertion of permanent material in the glabellar area * Neuromuscular function disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's assessment according to the Facial Wrinkle Scale (FWS) | Day 30 | Responder: FWS score of 0 or 1. |
| Patient's global assessment | Day 30 | Responder: subjects with a score of at least 2+. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's assessment according to FWS | Day 7, 60, 90, and 120 | Responder: FWS score of 0 or 1. |
| Patient's global assessment | Day 7, 60, 90, and 120 | Responder: subjects with a score of at least 2+. |
Countries
Germany
Outcome results
None listed