A Phase 3, Randomized, Parallel-Group, Double-Blind, Multicenter Study Investigating the Safety and Efficacy of NT 201 Compared With Placebo in Adult Participants With Moderate to Severe Platysma Prominence in the United States
Merz North America, Inc.
Summary
The purpose of this study is to assess the safety and efficacy of NT 201 compared with placebo in participants with moderate to severe platysma prominence. The study will be conducted in two periods: Main Period (MP) and Open label Extension Period (OLEX).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Presence of four (medial and lateral, left and right) platysmal bands assessed at screening and baseline. * A score of Grade 3 ('moderate') or Grade 4 ('severe') on the MAPS-D at maximum contraction by the investigator and participant. Exclusion Criteria: * Hypersensitivity or a history of allergic reaction to botulinum toxin of any serotype or any of their formulation ingredients. * Any medical condition that may put the participant at increased risk with exposure to botulinum toxin of any serotype, or any disorders that might interfere with neuromuscular function. *…
Interventions
- DrugNT 201
Clostridium Botulinum neurotoxin A (150 kiloDalton \[kD\], free of complexing proteins), powder for solution for injection.
- DrugNT 201 Placebo
NT 201 matching-placebo
Locations (28)
- Merz Investigative SiteScottsdale, Arizona
- Merz Investigative SiteEncino, California
- Merz Investigative SiteLos Angeles, California
- Merz Investigative SiteRedondo Beach, California
- Merz Investigative SiteSanta Monica, California
- Merz Investigative SiteVista, California