Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy

NCT04294251 | Completed Phase 3

• 1 other identifier: DW_DWP450301
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in masseter muscle thickness

  Change from baseline in masseter muscle thickness by Ultrasonography

  12 weeks

Secondary Outcomes (3)

• Change from baseline in masseter muscle thickness

  24 weeks

• Change from baseline in lower face volume

  24 weeks

• Overall satisfaction of subject: questionnaire

  24 weeks

Study Arms (2)

DWP450

EXPERIMENTAL

Drug: DWP450

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

DWP450 DRUG

Botulinum toxin type A(DWP450) will be administered intramuscularly to the bilateral masseter muscles on Day 1.

DWP450

Placebo DRUG

Placebo(Normal Saline) will be administered intramuscularly to the bilateral masseter muscles on Day 1.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
• 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.
• Subject who had previously received botulinum toxin within 12 weeks prior to the study entry.
• Subject with known hypersensitivity to botulinum toxin.
• Subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study period.
• Subjects who are not eligible for this study at the discretion of the investigator.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Chung-ang University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

DWP450

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: March 4, 2020
• Primary Completion: January 7, 2021
• Study Completion: August 10, 2021
• Last Updated: November 30, 2022

Record last verified: 2020-07

Locations

KR (1)