Benign Masseteric Hypertrophy
Conditions
Keywords
BMH
Brief summary
A double-blind, randomized, placebo-controlled, multi-center, phase III study to evaluate the efficacy and safety of LIZTOX in subjects with benign Masseteric hypertrophy
Interventions
DRUGBotulinum toxin type A
Botulinum toxin type A(HU-014) will be administered intramuscularly to the bilateral masseter muscles on Visit 2.
DRUGnormal Saline
Normal Saline will be administered intramuscularly to the bilateral masseter muscles on Visit 2.
Sponsors
Huons Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subject over 19 years of age and written informed consent is obtained. * Subject who has bilaterally symmetrical of masseter at visual and palpable assessment. * Subject who average masseter muscle thickness of at least 14mm on each side in males and 12mm in females at maximum clenching by ultrasonography. * Subject who has a masseter muscle hypertrophy scale of 4(marked) or more as determined by investigator. * Subject who fully understands this clinical trial and voluntarily writes ICF in the clinical trial.
Exclusion criteria
* Subject who had previously received botulinum toxin within 12 weeks prior to the study entry. * Subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in masseter muscle area within 48 weeks prior to the study entry. * Subject who has a disease(e.g. Temporo mandibular joint disorder, etc.) * Subject who were diagnosed Myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition that might influence with neuromuscular function. * Subject who had taken medication(e.g. muscle relaxant, polypeptide antibiotics, aminoglycoside antibiotics, etc.) within 4 weeks prior to the study entry. * Subject who are hypersensitive to investigational drug components (botulinum toxin, serum albumin, etc.) * Subject who are pregnant or lactating or planing pregnancy or disagreed to avoid pregnancy during study period. * Subject who participate other clinical trials within 4 weeks prior to the study entry. * Subject who are not eligible for this study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average change from baseline in masseter muscle thickness on both sides at maximum clenching | 12weeks | The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average change from baseline in masseter muscle thickness on both sides at rest | 4, 8, 12, 16, 20, 24weeks | The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements. |
| Average rate change from baseline in masseter muscle thickness on both sides at maximum clenching | 4, 8, 12, 16, 20, 24weeks | The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements. |
| Average rate change from baseline in masseter muscle thickness on both sides at rest | 4, 8, 12, 16, 20, 24weeks | The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements. |
| Change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging | 4, 8, 12, 16, 20, 24weeks | When measuring, the volume of the lower face was measured twice and the average value was used. |
| Average change from baseline in masseter muscle thickness on both sides at maximum clenching | 4, 8, 16, 20, 24weeks | The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements. |
| The proportion of subjects who reported an overall improvement of more than 50% at maximum clenching and at rest. | 4, 8, 12, 16, 20, 24weeks | Overall improvement criteria: +4 (100% complete improvement) \ -4 (100% very marked worsening) |
| The proportion of subjects who rated overall satisfaction as 'satisfied' at maximum clenching and at rest | 4, 8, 12, 16, 20, 24weeks | Overall satisfaction criteria: grade 1 (very dissatisfied) \ grade 7 (very satisfied), Grade 6 or higher (satisfied, very satisfied) is evaluated as satisfied. |
| The proportion of subjects with a masseter muscle hypertrophy scale (MMHS) ≤3 | 4, 8, 12, 16, 20, 24weeks | MMHS Evaluation criteria: The facial contour and the condition of the bilateral masseter muscles are assessed on a scale from grade 1 (minimal) to grade 5 (very marked). |
| Rate of change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging | 4, 8, 12, 16, 20, 24weeks | When measuring, the volume of the lower face was measured twice and the average value was used. |
Countries
South Korea
Outcome results
None listed