Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-26 @ 2:29 PM
Study NCT ID:
NCT00463359
Status:
UNKNOWN
Last Update Posted:
2007-04-20
First Post:
2007-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study of the Treatment of Facial Nodular and Nodulocystic Basal Cell Carcinoma With Double Curettage and Cautery Followed by Application of Imiquimod to the Base
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003475', 'term': 'Curettage'}, {'id': 'D002425', 'term': 'Cautery'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'lastUpdateSubmitDate': '2007-04-19', 'studyFirstSubmitDate': '2007-04-19', 'studyFirstSubmitQcDate': '2007-04-19', 'lastUpdatePostDateStruct': {'date': '2007-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Basal Cell Carcinoma recurrence rates in 3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['basal cell carcinoma', 'curettage', 'Imiquimod', 'treatment'], 'conditions': ['Basal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine recurrence rates of nodular Basal Cell Carcinomas on the face removed with curettage and electrodessication (cautery) followed by application of Imiquimod cream to the base and further to achieve lower recurrence rates than after treatment with curettage and electrodessication alone.', 'detailedDescription': 'Basal Cell Carcinomas (BCC) are the commonest form of skin cancer in the white population. The face is where they most frequently occur and the nodular BCCs are the commonest type. Curettage and cautery/electrodessication (C\\&C) has been an established way of management of nodular BCCs for years, being a simple surgical procedure readily performed in outpatient clinics with good aesthetic results and high cure rates. The purpose of this study is to determine recurrence rates of nodular BCCs on the face removed with C\\&C followed by application of Imiquimod cream to the base and further to achieve lower recurrence rates than after treatment with C\\&C alone. Imiquimod is an immune response modifier with anti-tumour effects already licensed for the treatment of superficial BCCs in the UK.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '49 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Well-defined primary, not previously treated nodulo-cystic BCC\n* Size of the lesions: ≤ 1cm diameter\n* Facial lesions\n* Patient compliance competent\n* Patient physically able to apply the treatment (cream)\n\nExclusion Criteria:\n\n* Recurrent lesions\n* Superficial, morphoeic or pigmented BCC\n* Lesions close to vital structures; i.e. where C\\&C is not considered a standard treatment (eyelids, inner canthus, free borders)\n* Lesions within 1 cm of the eyelids, nose, lips and hairline\n* Immunosuppressed patients\n* Women in childbearing age, pregnancy and breast-feeding\n* Ages \\<50 or \\>90\n* Patients compliance incompetent\n* Patients physically incapable to apply the treatment (cream)\n* Patients with Gorlin Syndrome (nevoid Basal Cell Carcinoma syndrome)'}, 'identificationModule': {'nctId': 'NCT00463359', 'briefTitle': 'A Pilot Study of the Treatment of Facial Nodular and Nodulocystic Basal Cell Carcinoma With Double Curettage and Cautery Followed by Application of Imiquimod to the Base', 'organization': {'class': 'OTHER', 'fullName': 'University of Glasgow'}, 'officialTitle': 'A Pilot Study of the Treatment of Facial Nodular and Nodulocystic Basal Cell Carcinoma With Double Curettage and Cautery Followed by Application of Imiquimod to the Base', 'orgStudyIdInfo': {'id': 'WN07DE002'}, 'secondaryIdInfos': [{'id': 'EudraCT No: 2007-001961-14'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Imiquimod cream', 'type': 'DRUG'}, {'name': 'curettage and cautery', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G11 6NT', 'city': 'Glasgow', 'state': 'Lanarkshire', 'country': 'United Kingdom', 'contacts': [{'name': 'Robert Herd, Consultant Dermatologist', 'role': 'CONTACT', 'email': 'robert.herd@northglasgow.scot.nhs.uk', 'phone': '+441412111000', 'phoneExt': '6259'}, {'name': 'Areti Makrygeorgou, Staff Grade Dr', 'role': 'CONTACT', 'email': 'amakrygeorgou@hotmail.com', 'phone': '+441412111000', 'phoneExt': '2903'}, {'name': 'Areti Makrygeorgou, Staff Grade Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Robert Herd, Consultant Dermatologist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lorna MacKintosh, Specialist Registrar', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dermatology Department, Western Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'centralContacts': [{'name': 'Robert Herd, Consultant Dermatologist', 'role': 'CONTACT', 'email': 'robert.herd@northglasgow.scot.nhs.uk', 'phone': '+441412111000', 'phoneExt': '6259'}], 'overallOfficials': [{'name': 'Lorna MacKintosh, Specialist Registrar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western Infirmary'}, {'name': 'Areti Makrygeorgou, Staff Grade Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Western Infirmary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Glasgow', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, {'name': 'Glasgow Western Infirmary', 'class': 'OTHER'}]}}}