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

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

Study Overview

• Status: Completed
• Conditions: Benign Masseteric Hypertrophy
• Intervention / Treatment: Drug: DWP450; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female subject over 18 years of age and written informed consent is obtained.
2. Subject with Benign Masseter Hypertrophy.
3. Subject who has Bisymmetry of masseter at visual assessment.
4. Subjects who meets thickness of Masseter muscle by ultrasonography.
5. Subjects who can and will comply with the requirements of the protocol.

Exclusion Criteria:

1. Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
2. Subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in lower facial area within 52 weeks prior to the study entry.
3. Subject who had previously received botulinum toxin within 12 weeks prior to the study entry.
4. Subject with known hypersensitivity to botulinum toxin.
5. Subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study period.
6. Subjects who are not eligible for this study at the discretion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo(Normal Saline) will be administered intramuscularly to the bilateral masseter muscles on Day 1.
EXPERIMENTAL: DWP450	Drug: DWP450; Botulinum toxin type A(DWP450) will be administered intramuscularly to the bilateral masseter muscles on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in masseter muscle thickness	Change from baseline in masseter muscle thickness by Ultrasonography	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in masseter muscle thickness	Change from baseline in masseter muscle thickness by Ultrasonography	24 weeks
Change from baseline in lower face volume	Change from baseline in lower face volume by 3D digital imaging	24 weeks
Overall satisfaction of subject: questionnaire	Subject satisfaction assessment using a scale ranging from very dissatisfied to very satisfied by questionnaire	24 weeks

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 4, 2020
• Primary Completion (ACTUAL): January 7, 2021
• Study Completion (ACTUAL): August 10, 2021

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (ACTUAL): March 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: DW_DWP450301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No