Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT01791920
Status:
COMPLETED
Last Update Posted:
2022-04-15
First Post:
2013-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 262}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2013-02-13', 'studyFirstSubmitQcDate': '2013-02-13', 'lastUpdatePostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Responder rate of improvement in glabellar lines with Physician's rating of line severity", 'timeFrame': 'at 4 weeks post-injection', 'description': "Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 4weeks post injection."}], 'secondaryOutcomes': [{'measure': 'Safety evaluation in experimental drug treatment group', 'timeFrame': '4, 8, 12, 16 weeks post-injection'}, {'measure': "Responder rate of improvement in glabellar lines with Physician's rating of line severity", 'timeFrame': '8, 12, 16 weeks post-injection', 'description': "Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 8, 12, 16weeks post injection."}, {'measure': "Responder rate of improvement in glabellar lines at rest with investigator's live assessment of severity", 'timeFrame': '4, 8, 12, 16 weeks post-injection', 'description': "Improvement rate of glabellar lines at rest with investigator's live assessment of severity at 4, 8, 12, 16weeks post injection"}, {'measure': "Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment", 'timeFrame': '4, 8, 12, 16 weeks post-injection', 'description': "Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 4, 8, 12, 16weeks post injection"}, {'measure': "Responder rate of improvement in glabellar lines at rest with investigator's photo assessment", 'timeFrame': '4, 8, 12, 16 weeks post inejection', 'description': "Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16weeks post injection"}, {'measure': "Responder rate of improvement in glabellar lines with Subject's improvement assessment", 'timeFrame': '4, 8, 12, 16 weeks post-injections', 'description': "Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16weeks post injection"}, {'measure': "Subject's satisfaction rate", 'timeFrame': '4, 8, 12, 16 weeks post-injection', 'description': "Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Skin Aging']}, 'descriptionModule': {'briefSummary': 'To compare the safety and efficacy of Botulax® with Botox® in the 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* Patients attaining grade 2 or 3 in the investigator's rating of glabellar lines severity at maximum frown\n* Patients who voluntarily sign the informed consent\n* Patients who can comply with the study procedures and visit schedule\n\nExclusion Criteria:\n\n* Subjects who had facial plastic surgery (tissue augmentation, brow lift, and dermal resurfacing)treatment within 6 months. Those who had peeling or laser therapy\n* Subjects with skin disorders, scar or infection around glabellar region\n* Subjects who are taking Aspirin, NSAIDS or anti-coagulant\n* Subjects with facial palsy or eyelid ptosis\n* Subjects who diagnosed as neuromuscular junction disorder (e.g., myasthenia gravis, Lambert-Eaton Syndrome)\n* Subjects with history of drug intoxication, alcohol abuse and/or depressive disorder\n* Subjects with severe internal diseases (cardiovascular, respiratory, renal disease, liver disorder)\n* Subjects who have previously been treated with botulinum toxin within 3 months (Botulinum toxin type A: 3months, type B: 4 months)\n* Subject who have administered following drugs within the previous 4 months: Spectinomycin Hydrochloride, Aminoglycoside antibiotics, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics, muscle relaxants, anti-cholinergic agents, benzodiazepine and similar drugs, benzamide drugs, Tubocurarine-type muscle relaxants\n* Subjects who have possibility to take the drugs listed above\n* Subjects who have a plan to receive facial cosmetic procedures including dermal filler, chemical peeling and dermabrasion during study period\n* Subjects who have glabellar lines that are unable to be improved with any physical method\n* Subjects who have history of hypersensitivity to Botulinum toxin and other agents\n* Subjects who are pregnant or breast-feeding\n* Subjects who have a plan to be pregnant in 3months, or who are not doing contraceptive\n* Subjects who participated in other studies within 30 days or were not passed over 5 times of half life for investigational product\n* Subjects who are having trouble with acute disease\n* Subjects who have taken any treatment that can affect to glabellar lines and/or any lines around forehead within the previous 6 months\n* Subjects who are unable to communicate or follow the instructions\n* Subjects who are not eligible for this study based on investigator's judgement"}, 'identificationModule': {'nctId': 'NCT01791920', 'briefTitle': 'To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hugel'}, 'officialTitle': 'Double-blinded, Randomized, Active Control Comparative, Multicenter-designed, Phase III Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of "Botulax®" Compared to Botox Inj. in Patients With Moderate to Severe Glabellar Lines', 'orgStudyIdInfo': {'id': 'HG-11-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Botulinum toxin type A(Botox®)', 'description': 'Botulinum toxin type A', 'interventionNames': ['Drug: Botulinum toxin type A(Botulax®)']}, {'type': 'EXPERIMENTAL', 'label': 'Botulinum toxin type A (Botulax®)', 'description': 'Botulinum toxin type A', 'interventionNames': ['Drug: Botulinum toxin type A(Botox®)']}], 'interventions': [{'name': 'Botulinum toxin type A(Botulax®)', 'type': 'DRUG', 'description': 'Single administration, Day 0, 20 units', 'armGroupLabels': ['Botulinum toxin type A(Botox®)']}, {'name': 'Botulinum toxin type A(Botox®)', 'type': 'DRUG', 'description': 'Single administration, Day 0, 20units', 'armGroupLabels': ['Botulinum toxin type A (Botulax®)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Dongjak-gu', 'country': 'South Korea', 'facility': 'Chung-Ang University Hopspital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'state': 'Jongno-Gu', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'state': 'Jung-Gu', 'country': 'South Korea', 'facility': 'National Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'state': 'Nowon-Gu', 'country': 'South Korea', 'facility': 'Eulji General Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'state': 'Seocho-Gu', 'country': 'South Korea', 'facility': "The catholic university of Korea, Seoul ST. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'state': 'Seongbuk-Gu', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hugel', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}