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Completed

NCT Number: NCT04294251

Efficacy and Safety of DWP450 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

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Key information

Conditions

Benign Masseteric Hypertrophy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chung-ang University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

DWP450

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Change from baseline in masseter muscle thickness

    Time frame: 12 weeks

    Change from baseline in masseter muscle thickness by Ultrasonography

Secondary outcomes

  1. Change from baseline in masseter muscle thickness

    Time frame: 24 weeks

    Change from baseline in masseter muscle thickness by Ultrasonography

  2. Change from baseline in lower face volume

    Time frame: 24 weeks

    Change from baseline in lower face volume by 3D digital imaging

  3. Overall satisfaction of subject: questionnaire

    Time frame: 24 weeks

    Subject satisfaction assessment using a scale ranging from very dissatisfied to very satisfied by questionnaire

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2020
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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