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
Overview
- Phase
- Phase 3
- Intervention
- IncobotulinumtoxinA (Xeomin)
- Conditions
- Lateral Periorbital Wrinkles
- Sponsor
- Merz Pharmaceuticals GmbH
- Enrollment
- 111
- Primary Endpoint
- Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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
Conducted in Europe
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •Significant facial asymmetry
Arms & Interventions
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.
Intervention: IncobotulinumtoxinA (Xeomin)
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.
Intervention: Placebo
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.
Intervention: IncobotulinumtoxinA (Xeomin)
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline.
Time Frame: Week 4
Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.
Secondary Outcomes
- Response assessed by the investigator at maximum smile for either eye area compared to baseline.(Weeks 2, 4, 12, and 20)
- Response assessed by the subject's global assessment at maximum smile for either eye area compared to baseline.(Weeks 2, 4, 12, and 20)