Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy

NCT04294251 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-11-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-04
Primary Completion
2021-01-07
Completion
2021-08-10

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04294251 on ClinicalTrials.gov