Efficacy and Safety of NT 201 in the Treatment of Lateral Periorbital Wrinkles

Study Overview
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Brief Summary
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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).

Detailed Description
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Conducted in Europe

Official Title
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A Prospective, Randomized, Double-Blind, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 in Comparison to Placebo and to Compare Two Different Application Schemes of NT 201 in the Treatment of Lateral Periorbital Wrinkles

Conditions
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Lateral Periorbital Wrinkles

Intervention / Treatment
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* Drug: IncobotulinumtoxinA (Xeomin)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IncobutolinumtoxinA (Xeomin), 4-injection scheme<br>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. | Drug: IncobotulinumtoxinA (Xeomin)<br>* 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)<br>|
| Placebo Comparator: Placebo 4-injection scheme<br>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. | Drug: Placebo<br>* Intramuscular injection at day 0, at 3 and 4 injection sites per eye.<br>|
| Experimental: IncobotulinumtoxinA (Xeomin), 3-injection scheme<br>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. | Drug: IncobotulinumtoxinA (Xeomin)<br>* 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)<br>|
| Placebo Comparator: Placebo 3-injection Scheme<br>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. | Drug: Placebo<br>* Intramuscular injection at day 0, at 3 and 4 injection sites per eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |