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
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Glabellar Frown Lines
- Sponsor
- Merz Pharmaceuticals GmbH
- Enrollment
- 256
- Locations
- 1
- Primary Endpoint
- Investigator's assessment according to the Facial Wrinkle Scale (FWS)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Moderate to severe glabellar frown lines
Exclusion Criteria
- •Previous insertion of permanent material in the glabellar area
- •Neuromuscular function disease
Arms & Interventions
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
Intervention: Placebo
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
Intervention: IncobotulinumtoxinA (Xeomin) (20 Units)
Outcomes
Primary Outcomes
Investigator's assessment according to the Facial Wrinkle Scale (FWS)
Time Frame: Day 30
Responder: FWS score of 0 or 1.
Patient's global assessment
Time Frame: Day 30
Responder: subjects with a score of at least 2+.
Secondary Outcomes
- Investigator's assessment according to FWS(Day 7, 60, 90, and 120)
- Patient's global assessment(Day 7, 60, 90, and 120)