Status:
ACTIVE_NOT_RECRUITING
To Evaluate the Efficacy and Safety of LIZTOX in Subjects with Benign Masseteric Hypertrophy
Lead Sponsor:
Huons Biopharma
Conditions:
Benign Masseteric Hypertrophy
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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
- 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
- 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.
Key Trial Info
Start Date :
July 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT05964257
Start Date
July 25 2023
End Date
May 30 2025
Last Update
September 26 2024
Active Locations (1)
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1
Chung-Ang University Hospital
Dongjak, Seoul, South Korea