Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-31 @ 1:44 AM
Study NCT ID:
NCT00849992
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2009-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535669', 'term': 'Actinic cheilitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077271', 'term': 'Imiquimod'}, {'id': 'D010778', 'term': 'Photochemotherapy'}], 'ancestors': [{'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-12', 'studyFirstSubmitDate': '2009-02-23', 'studyFirstSubmitQcDate': '2009-02-23', 'lastUpdatePostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical and pathological complete cure rates.', 'timeFrame': '3 and 12 months after therapy'}], 'secondaryOutcomes': [{'measure': 'clinical, safety, epidemiological and histopathological data', 'timeFrame': 'post-treatment', 'description': 'Through collecting patient data and post-treatment biopsy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Actinic cheilitis', 'Imiquimod 5%', 'Photodynamic therapy'], 'conditions': ['Actinic Cheilitis']}, 'descriptionModule': {'briefSummary': 'Actinic cheilitis is a common precancerous lesion of the lip. The purpose of this study is to compare imiquimod 5% therapy and photodynamic therapy. The data will include effect data, histology (skin analysis), epidemiological data and follow-up data.', 'detailedDescription': 'Randomized study comparing imiquimod 5% with photodynamic therapy for actinic cheilitis. Histological, efficacy, epidemiological and clinical data will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical findings of actinic cheilitis.\n* Histological findings demonstrating epithelial changes equal to or greater than mild epithelial dysplasia in severity (mild - moderate - severe).\n* Age above 18.\n* Willingness to take post-treatment biopsy.\n\nExclusion Criteria:\n\n* Disorders predisposing to photosensitivity (porphyria, SLE).\n* Pregnancy or nursing.\n* Known allergy to any excipients in the study creams.\n* prescribed topical retinoids, 5-fluorouracil, cryodestruction, surgical excision and curettage.'}, 'identificationModule': {'nctId': 'NCT00849992', 'briefTitle': 'Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Randomized Prospective Study Comparing 5% Imiquimod and Photodynamic Therapy for Actinic Cheilitis', 'orgStudyIdInfo': {'id': '20115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Imiquimod 5%', 'description': 'Patients randomized to this arm will receive treatment with imiquimod 5%', 'interventionNames': ['Drug: Imiquimod 5%']}, {'type': 'OTHER', 'label': 'Photodynamic therapy', 'description': 'Patients will be randomized to receive photodynamic therapy twice at a 2 week interval to the affected area.', 'interventionNames': ['Procedure: Photodynamic therapy']}], 'interventions': [{'name': 'Imiquimod 5%', 'type': 'DRUG', 'otherNames': ['Aldara'], 'description': 'Imiquimod 5% cream used three days a week for 4 weeks', 'armGroupLabels': ['Imiquimod 5%']}, {'name': 'Photodynamic therapy', 'type': 'PROCEDURE', 'description': 'Photodynamic therapy involves applying Metvix cream to the affected area followed by illumination. It will be done twice during the study at a 2 week interval.', 'armGroupLabels': ['Photodynamic therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'St. Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Stein H Sundstrøm, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Olavs Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}