Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-04 @ 4:54 PM
Study NCT ID:
NCT05964257
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-26
First Post:
2023-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy and Safety of LIZTOX in Subjects with Benign Masseteric Hypertrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2023-07-18', 'studyFirstSubmitQcDate': '2023-07-26', 'lastUpdatePostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average change from baseline in masseter muscle thickness on both sides at maximum clenching', 'timeFrame': '12weeks', 'description': 'The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.'}], 'secondaryOutcomes': [{'measure': 'Average change from baseline in masseter muscle thickness on both sides at maximum clenching', 'timeFrame': '4, 8, 16, 20, 24weeks', 'description': 'The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.'}, {'measure': 'Average change from baseline in masseter muscle thickness on both sides at rest', 'timeFrame': '4, 8, 12, 16, 20, 24weeks', 'description': 'The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.'}, {'measure': 'Average rate change from baseline in masseter muscle thickness on both sides at maximum clenching', 'timeFrame': '4, 8, 12, 16, 20, 24weeks', 'description': 'The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.'}, {'measure': 'Average rate change from baseline in masseter muscle thickness on both sides at rest', 'timeFrame': '4, 8, 12, 16, 20, 24weeks', 'description': 'The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.'}, {'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', 'description': 'When measuring, the volume of the lower face was measured twice and the average value was used.'}, {'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', 'description': 'When measuring, the volume of the lower face was measured twice and the average value was used.'}, {'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', 'description': 'Overall improvement criteria: +4 (100% complete improvement) \\~ -4 (100% very marked worsening)'}, {'measure': "The proportion of subjects who rated overall satisfaction as 'satisfied' at maximum clenching and at rest", 'timeFrame': '4, 8, 12, 16, 20, 24weeks', 'description': 'Overall satisfaction criteria: grade 1 (very dissatisfied) \\~ grade 7 (very satisfied), Grade 6 or higher (satisfied, very satisfied) is evaluated as satisfied.'}, {'measure': 'The proportion of subjects with a masseter muscle hypertrophy scale (MMHS) ≤3', 'timeFrame': '4, 8, 12, 16, 20, 24weeks', 'description': '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).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMH'], 'conditions': ['Benign Masseteric Hypertrophy']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subject over 19 years of age and written informed consent is obtained.\n* Subject who has bilaterally symmetrical of masseter at visual and palpable assessment.\n* Subject who average masseter muscle thickness of at least 14mm on each side in males and 12mm in females at maximum clenching by ultrasonography.\n* Subject who has a masseter muscle hypertrophy scale of 4(marked) or more as determined by investigator.\n* Subject who fully understands this clinical trial and voluntarily writes ICF in the clinical trial.\n\nExclusion Criteria:\n\n* Subject who had previously received botulinum toxin within 12 weeks prior to the study entry.\n* 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.\n* Subject who has a disease(e.g. Temporo mandibular joint disorder, etc.)\n* Subject who were diagnosed Myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition that might influence with neuromuscular function.\n* Subject who had taken medication(e.g. muscle relaxant, polypeptide antibiotics, aminoglycoside antibiotics, etc.) within 4 weeks prior to the study entry.\n* Subject who are hypersensitive to investigational drug components (botulinum toxin, serum albumin, etc.)\n* Subject who are pregnant or lactating or planing pregnancy or disagreed to avoid pregnancy during study period.\n* Subject who participate other clinical trials within 4 weeks prior to the study entry.\n* Subject who are not eligible for this study at the discretion of the investigator.'}, 'identificationModule': {'nctId': 'NCT05964257', 'briefTitle': 'To Evaluate the Efficacy and Safety of LIZTOX in Subjects with Benign Masseteric Hypertrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Huons Biopharma'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'HU-014_P3_BMH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HU-014', 'interventionNames': ['Drug: Botulinum toxin type A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: normal Saline']}], 'interventions': [{'name': 'Botulinum toxin type A', 'type': 'DRUG', 'description': 'Botulinum toxin type A(HU-014) will be administered intramuscularly to the bilateral masseter muscles on Visit 2.', 'armGroupLabels': ['HU-014']}, {'name': 'normal Saline', 'type': 'DRUG', 'description': 'Normal Saline will be administered intramuscularly to the bilateral masseter muscles on Visit 2.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dongjak', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-Ang University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huons Biopharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}