NCT04294251

Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy

A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase Ⅲ Study to Evaluate the Efficacy and Safety of NABOTA® in Subjects With Benign Masseteric Hypertrophy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Study is A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy

Conditions

• Benign Masseteric Hypertrophy

Interventions

Type	Name	Description
DRUG	DWP450	Botulinum toxin type A(DWP450) will be administered intramuscularly to the bilateral masseter muscles on Day 1.
DRUG	Placebo	Placebo(Normal Saline) will be administered intramuscularly to the bilateral masseter muscles on Day 1.

Timeline

• Start date: 2020-03-04
• Primary completion: 2021-01-07
• Completion: 2021-08-10
• First posted: 2020-03-04
• Last updated: 2022-11-30

Locations

1 site across 1 country: South Korea