Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-29 @ 1:38 AM
Study NCT ID:
NCT03837561
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2019-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2019-02-07', 'studyFirstSubmitQcDate': '2019-02-07', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity", 'timeFrame': 'at 4 weeks after the injection.', 'description': 'An investigator makes a live assessment of subject\'s glabellar lines at maximum frown on a 4-grade scale (0 (none), 1 (mild), 2 (moderate) and 3 (severe)) 4 weeks after the administration of the investigational drug or the comparator. 0 or 1 point is considered as "improved" and glabellar line improvement rate is calculated.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glabellar Frown Lines']}, 'descriptionModule': {'briefSummary': 'To Confirm the non-inferiority of CUNOX® to BOTOX® in the glabellar line improvement of moderate to severe glabellar lines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women aged between 18 and 65\n* Subjects attaining ≥ grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum forced frown\n* Subjects who voluntarily sign the informed consent\n\nExclusion Criteria:\n\n* Subjects with allergy or hypersensitivity to the investigational drugs or their components\n* Subjects who are participating in other clinical trials or have participated in clinical trials 30 days before screening\n* Subjects who are not eligible for this study at the discretion of the investigator"}, 'identificationModule': {'nctId': 'NCT03837561', 'briefTitle': 'The Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medy-Tox'}, 'officialTitle': 'Phase Ⅲ, Randomized, Double-Blind, Active Controlled, Multi-Center, Clinical Trial to Evaluate the Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines', 'orgStudyIdInfo': {'id': 'MT01-RU18GBL301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cunox', 'description': 'Cunox (botulinum toxin type A), 0.1 mL injected into each of 5 sites once.', 'interventionNames': ['Drug: Cunox']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Botox', 'description': 'Botox (botulinum toxin type A), 0.1 mL injected into each of 5 sites once.', 'interventionNames': ['Drug: Botox']}], 'interventions': [{'name': 'Cunox', 'type': 'DRUG', 'description': 'Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.', 'armGroupLabels': ['Cunox']}, {'name': 'Botox', 'type': 'DRUG', 'description': 'Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.', 'armGroupLabels': ['Botox']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'Medical Center Capital-Health', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medy-Tox', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}