Back to resultsEfficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy
Primary Purpose
Benign Masseteric Hypertrophy
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWP450
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Benign Masseteric Hypertrophy
Eligibility Criteria
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.
Sites / Locations
- Chung-ang University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DWP450
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in masseter muscle thickness
Change from baseline in masseter muscle thickness by Ultrasonography
Secondary Outcome Measures
Change from baseline in masseter muscle thickness
Change from baseline in masseter muscle thickness by Ultrasonography
Change from baseline in lower face volume
Change from baseline in lower face volume by 3D digital imaging
Overall satisfaction of subject: questionnaire
Subject satisfaction assessment using a scale ranging from very dissatisfied to very satisfied by questionnaire
Full Information
NCT ID
NCT04294251
First Posted
March 2, 2020
Last Updated
November 28, 2022
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT04294251
Brief Title
Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 4, 2020 (Actual)
Primary Completion Date
January 7, 2021 (Actual)
Study Completion Date
August 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Masseteric Hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DWP450
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DWP450
Intervention Description
Botulinum toxin type A(DWP450) will be administered intramuscularly to the bilateral masseter muscles on Day 1.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo(Normal Saline) will be administered intramuscularly to the bilateral masseter muscles on Day 1.
Primary Outcome Measure Information:
Title
Change from baseline in masseter muscle thickness
Description
Change from baseline in masseter muscle thickness by Ultrasonography
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in masseter muscle thickness
Description
Change from baseline in masseter muscle thickness by Ultrasonography
Time Frame
24 weeks
Title
Change from baseline in lower face volume
Description
Change from baseline in lower face volume by 3D digital imaging
Time Frame
24 weeks
Title
Overall satisfaction of subject: questionnaire
Description
Subject satisfaction assessment using a scale ranging from very dissatisfied to very satisfied by questionnaire
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Chung-ang University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy
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