Efficacy and Safety of NT 201 in the Treatment of Lateral Periorbital Wrinkles
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Cannes, France
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Nice, France
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Paris, France
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Duesseldorf, Germany
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Karlsruhe, Germany
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Munich, Germany
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Starnberg, Germany
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Roma, Italy
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Bexley. Kent, United Kingdom
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Glasgow, United Kingdom
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London, United Kingdom
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Sutton Coldfield, United Kingdom
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IncobutolinumtoxinA (Xeomin), 4-injection scheme
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. |
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)
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Placebo Comparator: Placebo 4-injection scheme
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.
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Intramuscular injection at day 0, at 3 and 4 injection sites per eye.
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Experimental: IncobotulinumtoxinA (Xeomin), 3-injection scheme
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. |
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)
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Placebo Comparator: Placebo 3-injection Scheme
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.
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Intramuscular injection at day 0, at 3 and 4 injection sites per eye.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline.
Time Frame: Week 4
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Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.
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Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Response assessed by the investigator at maximum smile for either eye area compared to baseline.
Time Frame: Weeks 2, 4, 12, and 20
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Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.
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Weeks 2, 4, 12, and 20
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Response assessed by the subject's global assessment at maximum smile for either eye area compared to baseline.
Time Frame: Weeks 2, 4, 12, and 20
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Responder: subjects with at least a moderate improvement, i.e. a score of at least +2 on a 9 point Likert scale.
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Weeks 2, 4, 12, and 20
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Eccleston, MD, MediZen, Sutton Coldfield, United Kingdom
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRZ 60201-0617/1
- 2006-005396-17 (EudraCT Number)
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