A Phase 3 interventional study of IncobotulinumtoxinA (Xeomin) and Placebo in Lateral Periorbital Wrinkles, sponsored by Merz Pharmaceuticals GmbH. Completed at 12 sites in 4 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-03-08.
Sponsored by Merz Pharmaceuticals GmbH · Phase 3, Interventional, and Treatment
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
Merz Pharmaceuticals GmbH is the lead sponsor of 60 studies on the registry; none are open to participants now.
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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)
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
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)
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
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)
Intramuscular injection at day 0, at 3 and 4 injection sites per eye.
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.
Time frame: Week 4
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.
Time frame: 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.
Time frame: Weeks 2, 4, 12, and 20
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Merz Pharmaceuticals GmbH