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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding to total placebo volume 0.5 mL; mode of administration: intramuscular injection |
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| IncobotulinumtoxinA (Xeomin) (20 Units) | Experimental | IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl), 20 units, total volume 0.5 mL, mode of administration: intramuscular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IncobotulinumtoxinA (Xeomin) (20 Units) | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's assessment according to the Facial Wrinkle Scale (FWS) | Responder: FWS score of 0 or 1. | Day 30 |
| Patient's global assessment | Responder: subjects with a score of at least 2+. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's assessment according to FWS | Responder: FWS score of 0 or 1. | Day 7, 60, 90, and 120 |
| Patient's global assessment | Responder: subjects with a score of at least 2+. |
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Inclusion Criteria:
•Moderate to severe glabellar frown lines
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | Merz Pharmaceuticals GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Pharmaceuticals GmbH | Frankfurt | 60318 | Germany |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
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| Drug |
|
| Day 7, 60, 90, and 120 |