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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-005396-17 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IncobutolinumtoxinA (Xeomin), 4-injection scheme | Experimental | IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150kD), free of complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free of complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl); total volume 0.24 mL per side, i.e. 4 x 0.06 mL (4 x 3 units = 12 units); mode of administration: intramuscular injection. |
|
| Placebo 4-injection scheme | 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; total volume 0.24 mL per side, i.e. 4 x 0.06 mL placebo solution; mode of administration: intramuscular injection. |
|
| IncobotulinumtoxinA (Xeomin), 3-injection scheme | Experimental | IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150kD), free of complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free of complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl); total volume 0.24 mL per side, i.e. 3 x 0.08 mL (3 x 4 units = 12 units); Mode of administration: intramuscular injection. |
|
| Placebo 3-injection Scheme | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IncobotulinumtoxinA (Xeomin) | Drug | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 2, 4, 12, and 20 |
| Response assessed by the subject's global assessment at maximum smile for either eye area compared to baseline. |
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Main Inclusion Criteria:
- Moderate (grade 2) to severe (grade 3) symmetrical lateral periorbital wrinkles assessed by the investigator according to the 4-point scale at maximum smile
Main Exclusion Criteria:
- Significant facial asymmetry
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| Name | Affiliation | Role |
|---|---|---|
| David Eccleston, MD | MediZen, Sutton Coldfield, United Kingdom | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cannes | France | |||||
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Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; total volume 0.24 mL per side, i.e. 3 x 0.08 mL placebo solution; mode of administration: intramuscular injection.
|
| Placebo | Drug | Intramuscular injection at day 0, at 3 and 4 injection sites per eye. |
|
Responder: subjects with at least a moderate improvement, i.e. a score of at least +2 on a 9 point Likert scale. |
| Weeks 2, 4, 12, and 20 |
| Nice |
| France |
| Paris | France |
| Düsseldorf | Germany |
| Karlsruhe | Germany |
| Munich | Germany |
| Starnberg | Germany |
| Roma | Italy |
| Bexley. Kent | United Kingdom |
| Glasgow | United Kingdom |
| London | United Kingdom |
| Sutton Coldfield | United Kingdom |
| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
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