IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines
NCT ID: NCT00770211
Last Updated: 2011-10-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
271 participants
INTERVENTIONAL
2008-10-31
2009-06-30
Brief Summary
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Detailed Description
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Eight (8) sites in the United States participated in this trial. The study was led by one Lead PI and a Co-Lead PI who was assisting the Lead PI. The role of the Lead PI and the Co-Lead PI was executed by one of the PIs of this study, respectively. The PI at each site was a medical doctor who was experienced in aesthetic dermatology, i.e. who had several years (\>= 2 years) of experience in treatment of glabellar frown lines with BTX-A preparations. The PI was the person who led the team at one trial site and who was responsible for the conduct of the clinical trial at the site. The sub-investigator was a member of the team designated by the PI to perform important trial-related decisions. A maximum number of two sub-investigators could be authorized for injection and rating if necessary. At each site, ideally one investigator was to inject and rate all subjects. Injecting and rating sub-investigators had to be medical doctors with several years of experience in treatment of glabellar frown lines with BTX-A preparations. A subject had to be rated by the same investigator at all visits. Another phase 3 trial MRZ 60201-0724/1 (NCT00770029) with design and endpoints identical to those in this trial was performed in order to compare efficacy and safety results with a second study population.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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IncobotulinumtoxinA (Xeomin) (20 Units)
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl), 20 units, total volume 0.5 mL, mode of administration: intramuscular injection
IncobotulinumtoxinA (Xeomin) (20 Units)
The treatment will be administered only once at day 0 at five injection sites in the glabellar area. The total dose of 20 Units IncobotulinumtoxinA (Xeomin) is reconstituted in a total injection volume of 0.5 mL that is to be injected to the five sites in equal aliquots of 0.1 mL.
Placebo
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding to total placebo volume 0.5 mL; mode of administration: intramuscular injection
Placebo
The treatment will be administered only once at day 0 at five injection sites in the glabellar area. Volume of Placebo equivalent to IncobotulinumtoxinA (Xeomin).
Interventions
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IncobotulinumtoxinA (Xeomin) (20 Units)
The treatment will be administered only once at day 0 at five injection sites in the glabellar area. The total dose of 20 Units IncobotulinumtoxinA (Xeomin) is reconstituted in a total injection volume of 0.5 mL that is to be injected to the five sites in equal aliquots of 0.1 mL.
Placebo
The treatment will be administered only once at day 0 at five injection sites in the glabellar area. Volume of Placebo equivalent to IncobotulinumtoxinA (Xeomin).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on Facial Wrinkle Scale as assessed by investigator's rating: 0= 'none', 1= 'mild', 2= 'moderate', 3= 'severe')
* Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on Facial Wrinkle Scale as assessed by patient's assessment: 0= 'none', 1= 'mild', 2= 'moderate', 3= 'severe')
* Stable medical condition
Exclusion Criteria
* Previous treatment with any facial aesthetic procedure (e.g. injection with biodegradable fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 month
* Previous insertion of permanent material in the glabellar area (regardless of the time between previous treatment and this study)
* Planned treatment with Botulinum toxin of any serotype in any other body region during the study period
* Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area and the surrounding areas (including eye brow)
* Any other planned facial aesthetic procedure during the trial period
* Inability to substantially lessen glabellar frown lines even by physically spreading them apart
* Marked facial asymmetry or ptosis of eyelid and/or eyebrow
* History of facial nerve palsy
* Any infection in the area of the injection sites
18 Years
ALL
No
Sponsors
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Merz Pharmaceuticals GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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William Hanke, MD
Role: PRINCIPAL_INVESTIGATOR
Rhoda Narins, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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About Skin Dermatoloy
Englewood, Colorado, United States
Center for Cosmetic Enhancement
Aventura, Florida, United States
Frederic Brandt
Coral Gables, Florida, United States
Advanced Dermatology Research Institute
Lincolnshire, Illinois, United States
Laser & Skin Surgery Center of Indiana
Carmel, Indiana, United States
Joel Schlessinger
Omaha, Nebraska, United States
Image Dermatology P.C.
Montclair, New Jersey, United States
Rhoda Narins
White Plains, New York, United States
Countries
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Other Identifiers
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MRZ 60201 - 0741 / 1
Identifier Type: -
Identifier Source: org_study_id