Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-03-09 @ 4:02 PM
Study NCT ID:
NCT04081402
Status:
UNKNOWN
Last Update Posted:
2019-09-09
First Post:
2019-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 'ESTIMATED', 'count': 290}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-05', 'studyFirstSubmitDate': '2019-09-05', 'studyFirstSubmitQcDate': '2019-09-05', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from Baseline of Crow's feet Lines improvement rate [Time Frame: Week 4]", 'timeFrame': '4 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Crow's Feet Lines"]}, 'descriptionModule': {'briefSummary': "A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator\n\nExclusion Criteria:\n\n* Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)\n* From screening, Subject who get a plastic Surgery within 48 Weeks\n* Subject who has skin disorder including infection and scar on injection site\n* Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc.\n* Subject who takes a medication including anticoagulant, antithrombotic drug except low dose aspirin (below 325 mg/day)\n* Any condition that, in the view of the investigator, would interfere with study participation'}, 'identificationModule': {'nctId': 'NCT04081402', 'briefTitle': "A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines", 'organization': {'class': 'INDUSTRY', 'fullName': 'Huons Co., Ltd.'}, 'officialTitle': "A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines", 'orgStudyIdInfo': {'id': 'HU-014_P1/3_CFL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HU-014 Inj', 'interventionNames': ['Biological: HU-014']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Botox Inj', 'interventionNames': ['Biological: Botox Inj']}], 'interventions': [{'name': 'HU-014', 'type': 'BIOLOGICAL', 'description': 'Hutox Inj(Clostridium botulinum type A)', 'armGroupLabels': ['HU-014 Inj']}, {'name': 'Botox Inj', 'type': 'BIOLOGICAL', 'description': 'Botox Inj(Clostridium botulinum type A)', 'armGroupLabels': ['Botox Inj']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Huon', 'role': 'CONTACT', 'phone': '07074925149'}], 'facility': 'Huons', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jungmin Yu, Researcher', 'role': 'CONTACT', 'email': 'jungmin-yu@huons.com', 'phone': '070-7492-5100'}, {'name': 'Yubeen Choi, Researcher', 'role': 'CONTACT', 'email': 'ybin9398@huons.com', 'phone': '070-7492-5965'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huons Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}