Efficacy and Safety of NT 201 in the Treatment of Lateral Periorbital Wrinkles
NCT ID: NCT00541723
Last Updated: 2012-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
111 participants
INTERVENTIONAL
2007-09-30
2008-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of NT 201 (IncobotulinumtoxinA [Xeomin]) in the Treatment of Glabellar Frown Lines
NCT00512135
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines
NCT00770211
Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Lateral Canthal Lines) in Subjects With Moderate to Severe Upper Facial Lines
NCT04594213
Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Crows Feet) in Subjects With Moderate to Severe Upper Facial Lines
NCT04622254
Split-Face Prospective Study Comparing Botox to Xeomin for the Treatment of Facial Wrinkles
NCT02122536
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
IncobotulinumtoxinA (Xeomin)
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)
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.
Placebo
Intramuscular injection at day 0, at 3 and 4 injection sites per eye.
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.
IncobotulinumtoxinA (Xeomin)
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)
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.
Placebo
Intramuscular injection at day 0, at 3 and 4 injection sites per eye.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IncobotulinumtoxinA (Xeomin)
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)
Placebo
Intramuscular injection at day 0, at 3 and 4 injection sites per eye.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merz Pharmaceuticals GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Eccleston, MD
Role: PRINCIPAL_INVESTIGATOR
MediZen, Sutton Coldfield, United Kingdom
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cannes, , France
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2006-005396-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MRZ 60201-0617/1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.