Benign Masseteric Hypertrophy
Conditions
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
Interventions
DRUGDWP450
Botulinum toxin type A(DWP450) will be administered intramuscularly to the bilateral masseter muscles on Day 1.
DRUGPlacebo
Placebo(Normal Saline) will be administered intramuscularly to the bilateral masseter muscles on Day 1.
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in masseter muscle thickness | 12 weeks | Change from baseline in masseter muscle thickness by Ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in masseter muscle thickness | 24 weeks | Change from baseline in masseter muscle thickness by Ultrasonography |
| Change from baseline in lower face volume | 24 weeks | Change from baseline in lower face volume by 3D digital imaging |
| Overall satisfaction of subject: questionnaire | 24 weeks | Subject satisfaction assessment using a scale ranging from very dissatisfied to very satisfied by questionnaire |
Countries
South Korea
Outcome results
None listed