Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2026-01-01 @ 6:26 AM
Study NCT ID:
NCT00189306
Status:
COMPLETED
Last Update Posted:
2010-08-10
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077271', 'term': 'Imiquimod'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jim.lee@gracewaypharma.com', 'phone': '267-984-0400', 'title': 'Medical Director', 'organization': 'Graceway Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).', 'eventGroups': [{'id': 'EG000', 'title': 'Aldara', 'description': 'Aldara (imiquimod) cream 5%', 'otherNumAtRisk': 169, 'otherNumAffected': 130, 'seriousNumAtRisk': 169, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Application site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 100, 'numAffected': 100}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}], 'seriousEvents': [{'term': 'Embolism pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Non-hodgkins lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Excision BCC R forehead', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Pulmonary carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Bleeding post colonoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Cholecyctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Colon carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Bladder carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Prostatic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Acute renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}, {'term': 'Chronic renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aldara', 'description': 'Aldara (imiquimod) cream 5%'}], 'classes': [{'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 data sets: ITT - all enrolled subjects and PP - ITT subjects free from major protocol violations and applied at least 60% of doses required'}, {'type': 'SECONDARY', 'title': 'Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aldara', 'description': 'Aldara (imiquimod) cream 5%'}], 'classes': [{'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 week posttreatment visit', 'description': 'Number of participants cleared at 12 weeks(the number of subjects with no clinical evidence of superficial basal cell carcinoma at the target tumor site at the 12-week posttreatment visit)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two data sets were analyzed: intent-to-treat (ITT), consisting of all enrolled subjects and per-protocol (PP), consisting of ITT subjects who were free from major protocol violations, and who applied at least 60% of the doses required by the dosing regimen.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aldara', 'description': 'Aldara (imiquimod) cream 5%'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '5 subjects discontinued during treatment - 4 subjects returned for the Posttreatment Period', 'groupId': 'FG000', 'numSubjects': '164'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Posttreatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '5 of the 169 discontinued, but 4 returned for the Posttreatment Period', 'groupId': 'FG000', 'numSubjects': '169'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '11 subjects discontinued during the 12-week Posttreatment Period', 'groupId': 'FG000', 'numSubjects': '157'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Target lesion excised', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Evidence of Superficial Basal Cell Ca', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Local skin reaction/sign', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Long-Term Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Intercurrent disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Evidence of Superficial Basal Cell Ca', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}]}], 'recruitmentDetails': 'Study conducted in 18 study centers: 13 in Australia and 5 in New Zealand. The first subject entered this study on 27 March 2001; the last clinic visit was on 20 April 2007 and the last subject status determination (subject lost to follow-up) was on 27 April 2007.', 'preAssignmentDetails': 'There were 169 subjects enrolled at 18 study centers in Australia and New Zealand.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aldara', 'description': 'Aldara (imiquimod) cream 5%'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '130', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-05', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2008-10-30', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2008-11-25', 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2008-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)', 'timeFrame': '5 years', 'description': 'Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks', 'timeFrame': '12 week posttreatment visit', 'description': 'Number of participants cleared at 12 weeks(the number of subjects with no clinical evidence of superficial basal cell carcinoma at the target tumor site at the 12-week posttreatment visit)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Superficial Basal Cell Carcinoma', 'Aldara'], 'conditions': ['Superficial Basal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '17034468', 'type': 'RESULT', 'citation': 'Quirk C, Gebauer K, Owens M, Stampone P. Two-year interim results from a 5-year study evaluating clinical recurrence of superficial basal cell carcinoma after treatment with imiquimod 5% cream daily for 6 weeks. Australas J Dermatol. 2006 Nov;47(4):258-65. doi: 10.1111/j.1440-0960.2006.00313.x.'}, {'pmid': '20666194', 'type': 'RESULT', 'citation': "Quirk C, Gebauer K, De'Ambrosis B, Slade HB, Meng TC. Sustained clearance of superficial basal cell carcinomas treated with imiquimod cream 5%: results of a prospective 5-year study. Cutis. 2010 Jun;85(6):318-24."}]}, 'descriptionModule': {'briefSummary': 'An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of follow-up.', 'detailedDescription': 'Evaluate the long-term sustained clearance rate, defined as the proportion of those subjects clinically clear of basal cell carcinoma (BCC) at the treated superficial BCC (sBCC) target tumor site at the 12-week posttreatment visit who remain clear during a 5 year follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have at least 1 previously untreated superficial basal cell carcinoma tumor\n* Minimum tumor size 0.5 cm2 and maximum diameter of 2.0 cm\n\nExclusion Criteria:\n\n* Evidence of clinically significant, unstable medical conditions\n* Cannot have recent use of topical steroids or retinoids in the treatment area.'}, 'identificationModule': {'nctId': 'NCT00189306', 'briefTitle': 'Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream', 'organization': {'class': 'INDUSTRY', 'fullName': 'Graceway Pharmaceuticals, LLC'}, 'officialTitle': 'An Open-label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 7 Days Per Week for 6 Weeks in the Treatment of Superficial Basal Cell Carcinoma', 'orgStudyIdInfo': {'id': '1413-IMIQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aldara', 'description': 'Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks', 'interventionNames': ['Drug: Imiquimod 5% cream']}], 'interventions': [{'name': 'Imiquimod 5% cream', 'type': 'DRUG', 'otherNames': ['Aldara (imiquimod) 5% cream - 250 mg / packet'], 'description': 'Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks', 'armGroupLabels': ['Aldara']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Concord', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Medical Centre, Concord Hospital', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'city': 'Benowa', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Skin Centre', 'geoPoint': {'lat': -28.0077, 'lon': 153.38583}}, {'city': 'Carina Heights', 'state': 'Queensland', 'country': 'Australia', 'facility': 'South East Dermatology Centre', 'geoPoint': {'lat': -27.50721, 'lon': 153.09126}}, {'city': 'Gulliver', 'state': 'Queensland', 'country': 'Australia', 'facility': '105 Fulham Road', 'geoPoint': {'lat': -19.28814, 'lon': 146.77691}}, {'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'city': 'Bedford Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Flinders Medical Center', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'city': 'Woodville', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': -34.877, 'lon': 138.54291}}, {'city': 'Footscray', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Western Hospital', 'geoPoint': {'lat': -37.8, 'lon': 144.9}}, {'city': 'Heidelburg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin & Repartriation Hospital'}, {'city': 'Fremantle', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Freemantle Dermatology', 'geoPoint': {'lat': -32.05632, 'lon': 115.74557}}, {'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': '158 South Terrace', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Subiaco', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Subiaco Clinic', 'geoPoint': {'lat': -31.9485, 'lon': 115.8268}}, {'city': 'Epsom', 'state': 'Auckland', 'country': 'New Zealand', 'facility': '103A Mountain Road', 'geoPoint': {'lat': -36.88745, 'lon': 174.77059}}, {'city': 'Parnell', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'Birthcare Building', 'geoPoint': {'lat': -36.86667, 'lon': 174.78333}}, {'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Colombo Mansions', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Dermatology Practice', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'city': 'Takapuna', 'country': 'New Zealand', 'facility': 'Skin Institute Limited', 'geoPoint': {'lat': -36.79167, 'lon': 174.77583}}], 'overallOfficials': [{'name': 'Jim Lee, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Graceway Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Graceway Pharmaceuticals, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Director', 'oldOrganization': 'Graceway Pharmaceuticals'}}}}