Clinical trial NCT05964257: To Evaluate the Efficacy and Safety of LIZTOX 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 LIZTOX in Subjects with Benign Masseteric Hypertrophy.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Benign Masseteric Hypertrophy
Keywords: BMH
Lead sponsor: Huons Biopharma
Sponsor class: INDUSTRY
First posted: 2023-07-27
Enrollment: 188
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Average change from baseline in masseter muscle thickness on both sides at maximum clenching
timeFrame: 12weeks
Secondary outcomes:
measure: Average change from baseline in masseter muscle thickness on both sides at maximum clenching
timeFrame: 4, 8, 16, 20, 24weeks
measure: Average change from baseline in masseter muscle thickness on both sides at rest
timeFrame: 4, 8, 12, 16, 20, 24weeks
measure: Average rate change from baseline in masseter muscle thickness on both sides at maximum clenching
timeFrame: 4, 8, 12, 16, 20, 24weeks
measure: Average rate change from baseline in masseter muscle thickness on both sides at rest
timeFrame: 4, 8, 12, 16, 20, 24weeks
measure: Change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging
timeFrame: 4, 8, 12, 16, 20, 24weeks
measure: Rate of change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging
timeFrame: 4, 8, 12, 16, 20, 24weeks
measure: The proportion of subjects who reported an overall improvement of more than 50% at maximum clenching and at rest.
timeFrame: 4, 8, 12, 16, 20, 24weeks
measure: The proportion of subjects who rated overall satisfaction as 'satisfied' at maximum clenching and at rest
timeFrame: 4, 8, 12, 16, 20, 24weeks
measure: The proportion of subjects with a masseter muscle hypertrophy scale (MMHS) ≤3
timeFrame: 4, 8, 12, 16, 20, 24weeks
Other outcomes:
Locations:
city: Dongjak
country: Korea, Republic of
facility: Chung-Ang University Hospital
state: Seoul
Study officials:
References: