Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-02-25 @ 4:49 PM
Study NCT ID:
NCT03908892
Status:
UNKNOWN
Last Update Posted:
2022-08-15
First Post:
2019-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Zanthoxylum Nitidum Tincture for Paronychia Caused by Afatinib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010304', 'term': 'Paronychia'}], 'ancestors': [{'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009260', 'term': 'Nail Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-11', 'studyFirstSubmitDate': '2019-02-21', 'studyFirstSubmitQcDate': '2019-04-07', 'lastUpdatePostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Paronychia progress rate', 'timeFrame': 'Through study completion, an average of 10 days.', 'description': 'Incidence of grade 2 or more paronychia during paronychia treatment period will be reported. This period will be from randomization till paronychia relief or progression. Frequency of evaluation for paronychia will be everyday.'}], 'secondaryOutcomes': [{'measure': 'Time to paronychia progress', 'timeFrame': 'Through study completion, an average of 10 days.', 'description': 'The time elapsed from randomization to either the date of grade 2 or more paronychia occurrence, treatment completion, or last follow-up information. Frequency of evaluation for paronychia will be everyday.'}, {'measure': 'Time to paronychia relief', 'timeFrame': 'Through study completion, an average of 10 days.', 'description': 'The time elapsed from randomization to either the date of paronychia relief, treatment completion, or last follow-up information. Paronychia relief is defined as that paronychia disappears. Frequency of evaluation for paronychia will be everyday.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Paronychia', 'Zanthoxylum nitidum tincture', 'Afatinib'], 'conditions': ['Paronychia']}, 'descriptionModule': {'briefSummary': 'This is a randomized control trial evaluating the efficacy of zanthoxylum nitidum tincture on preventing progression of paronychia caused by afatinib from grade 1 to grade 2/3. Enrolled participates will randomly receive original treatment or original treatment plus zanthoxylum nitidum tincture immersion of the sick nail(s).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathologically or cytologically confirmed non-small cell lung cancer；\n2. Undergoing treatment with afatinib；\n3. With grade 1 paronychia；\n4. Age between 18 to 80 years old；\n5. Estimated life expectancy of more than months；\n6. With the written informed consent.\n\nExclusion Criteria:\n\n1. Paronychia before afatinib treatment;\n2. Grade 2 or severer paronychia;\n3. Stop using afatinib or with reduced dose of afatinib;\n4. Currently diagnosed with severe encephalopathy or psychiatric disorders affecting patients ability of self expression.\n5. Has other legal, medical or ethical reasons that patients are not appropriate for clinical study.'}, 'identificationModule': {'nctId': 'NCT03908892', 'briefTitle': 'Effect of Zanthoxylum Nitidum Tincture for Paronychia Caused by Afatinib', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou University of Traditional Chinese Medicine'}, 'officialTitle': 'A Clinical Study on the Treatment of Paronychia Caused by Afatinib With Zanthoxylum Nitidum Tincture', 'orgStudyIdInfo': {'id': '2019KT1122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination group', 'description': 'Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day, plus local application with zanthoxylum nitidum tincture soaked blocks for the sick nail(s) for 30 minutes, twice a day, till paronychia relief or progression.', 'interventionNames': ['Drug: zanthoxylum nitidum tincture', 'Drug: tetracycline ointment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day, till paronychia relief or progression.', 'interventionNames': ['Drug: tetracycline ointment']}], 'interventions': [{'name': 'zanthoxylum nitidum tincture', 'type': 'DRUG', 'description': 'Local application with zanthoxylum nitidum tincture soaked blocks for the sick nail(s) for 30 minutes, twice a day.', 'armGroupLabels': ['Combination group']}, {'name': 'tetracycline ointment', 'type': 'DRUG', 'description': 'Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day', 'armGroupLabels': ['Combination group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanjuan Zhu, Dr.', 'role': 'CONTACT', 'email': 'zyjsophy@gzucm.edu.cn', 'phone': '86 20 81887233', 'phoneExt': '34830'}, {'name': 'Yihong Liu, Dr.', 'role': 'CONTACT', 'email': 'yihongl@gzucm.edu.cn', 'phone': '86 20 81887233', 'phoneExt': '34830'}, {'name': 'Haibo Zhang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Guangdong Provincial Hospital of Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yanjuan Zhu, Dr', 'role': 'CONTACT', 'email': 'zyjsophy@gzucm.edu.cn', 'phone': '86 20 81887233', 'phoneExt': '34830'}, {'name': 'Yihong Liu, Dr', 'role': 'CONTACT', 'email': 'yihongl@gzucm.edu.cn', 'phone': '80 20 81887233', 'phoneExt': '34830'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Haibo Zhang', 'investigatorAffiliation': 'Guangzhou University of Traditional Chinese Medicine'}}}}