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Efficacy and Safety of Nabota (DWP450) in Benign Masseteric Hypertrophy
NCT04294251Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2020
- Primary completion
- Jan 2021
- Countries
- 1
- Sponsor
- Daewoong Pharmaceutical
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- prabotulinumtoxinA
- Conditions
- benign masseteric hypertrophy (BMH)
01
Overview
Phase 3, randomised, double-blind trial in benign masseteric hypertrophy (BMH) comparing DWP450 with Placebo (2 arms). Primary endpoint: Change from baseline in masseter muscle thickness at 12 weeks. Started Mar 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
DWP450
Nabota (PrabotulinumtoxinA) intramuscular injection
Placebo
Normal Saline intramuscular injection
03
Who it enrols
Adult patients with benign masseteric hypertrophy and bisymmetry of the masseter muscle confirmed by ultrasonography, excluding those with neuromuscular conditions or recent facial aesthetic procedures.
04
Endpoints
Primary
Change from baseline in masseter muscle thickness
Secondary
Change from baseline in masseter muscle thickness
Change from baseline in lower face volume
Overall satisfaction of subject
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