IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines
A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Open-label Extension Period to Investigate the Efficacy and Safety of IncobotulinumtoxinA (Xeomin), Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
1 other identifier
interventional
256
1 country
1
Brief Summary
IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, IncobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study investigated the efficacy and safety of IncobotulinumtoxinA (Xeomin) in the treatment of glabellar frown lines compared to placebo. The study consisted of a Main Period and an Open-Label Extension \[OLEX\] Period of 120 days each.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2006
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 1, 2007
CompletedFirst Posted
Study publicly available on registry
February 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedOctober 26, 2011
October 1, 2011
6 months
February 1, 2007
October 25, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
Investigator's assessment according to the Facial Wrinkle Scale (FWS)
Responder: FWS score of 0 or 1.
Day 30
Patient's global assessment
Responder: subjects with a score of at least 2+.
Day 30
Secondary Outcomes (2)
Investigator's assessment according to FWS
Day 7, 60, 90, and 120
Patient's global assessment
Day 7, 60, 90, and 120
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo 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
IncobotulinumtoxinA (Xeomin) (20 Units)
EXPERIMENTALIncobotulinumtoxinA (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
Interventions
Eligibility Criteria
You may qualify if:
- Moderate to severe glabellar frown lines
You may not qualify if:
- Previous insertion of permanent material in the glabellar area
- Neuromuscular function disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Merz Pharmaceuticals GmbH
Frankfurt, 60318, Germany
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Medical Expert
Merz Pharmaceuticals GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2007
First Posted
February 2, 2007
Study Start
October 1, 2006
Primary Completion
April 1, 2007
Study Completion
November 1, 2007
Last Updated
October 26, 2011
Record last verified: 2011-10