Benign Masseteric Hypertrophy Clinical Trial
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.
Verified date | July 2023 |
Source | Huons Biopharma |
Contact | Ham kiltae |
Phone | +82-02-854-4700 |
kiltae.ham[@]HUONS.COM | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A double-blind, randomized, placebo-controlled, multi-center, phase III study to evaluate the efficacy and safety of LIZTOX in subjects with benign massesric hypertrophy
Status | Recruiting |
Enrollment | 168 |
Est. completion date | May 30, 2025 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - Male or female subject over 19 years of age and written informed consent is obtained. - Subject who has bisymmetry of masseter at visual and palpable assessment. - Subject who meets thickness of masseter muscle by ultrasonography. - Subject who has a scale of benign masseter hypertrophy of 4 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 lower facial 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, Eaton-Lambert 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 with known hypersensitivity to botulinum toxin. - 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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Chung-Ang University Hospital | Dongjak | Seoul |
Lead Sponsor | Collaborator |
---|---|
Huons Biopharma |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in masseter muscle thickness | Change from baseline in masseter muscle thickness by Ultrasonography | 12week |
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