Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-03-06 @ 9:39 PM
Study NCT ID:
NCT01806961
Status:
TERMINATED
Last Update Posted:
2016-08-03
First Post:
2013-03-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Observational Trial Tolerability and Efficacy of Resiquimod Gel in Patients Treated for Actinic Keratosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'francine.santoro@galderma.com', 'phone': '+41 62 387 87 87', 'title': 'Dr. Francine Santoro', 'phoneExt': '87 20', 'organization': 'Sipirig AG'}, 'certainAgreement': {'otherDetails': "There is an agreement between the PI and the Sponsor that restricts the PI's rights to discuss or publish trial results after the trial is completed.\n\nInvestigator is granted a right to publish and present Trial Results together with other investigators of Trial and to be referred to in publications containing such results. However, PI shall not publish or present Results unless Investigator has submitted to Spirig a draft of the intented publication or presentation for review and approval.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "No efficacy analysis was carried out since due to premature study termination (upon Sponsor's decision) no data was available for analysis"}}, 'adverseEventsModule': {'timeFrame': '7 months', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'Patients from SP848-AK-1101 trial', 'otherNumAtRisk': 16, 'otherNumAffected': 6, 'seriousNumAtRisk': 16, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'unspecific inflammation crus helicis left arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'wart', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'oesophageal acid reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hypercholesterolemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'carotid stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Basal cell carcinome lower back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Determine the Recurrence Rate of AK-lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Patients from SP848-AK-1101 trial'}], 'timeFrame': 'at 6 and 12 months', 'description': 'Number of patients with persistent complete clearance at 6 and 12 months follow-up. Recurrence rate is to be determined at the same treatment area where the investigational medicinal products were administered in the previous trial.', 'reportingStatus': 'POSTED', 'populationDescription': "No subject was analysed due to premature study termination (sponsor's decision) therefore no data was available for analysis"}, {'type': 'SECONDARY', 'title': 'Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes)', 'timeFrame': 'at 6 and 12 months', 'description': 'clinical examination', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area', 'timeFrame': 'at 6 and 12 months', 'description': 'recording of adverse events', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SP848-AK-1101', 'description': 'Patients from SP848-AK-1101 trial'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Clearance at End of Trial SP848-AK-1101', 'description': 'no trial medication during this follow-up trial'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000', 'lowerLimit': '53', 'upperLimit': '93'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-21', 'studyFirstSubmitDate': '2013-03-06', 'resultsFirstSubmitDate': '2015-12-14', 'studyFirstSubmitQcDate': '2013-03-06', 'lastUpdatePostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-14', 'studyFirstPostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the Recurrence Rate of AK-lesions', 'timeFrame': 'at 6 and 12 months', 'description': 'Number of patients with persistent complete clearance at 6 and 12 months follow-up. Recurrence rate is to be determined at the same treatment area where the investigational medicinal products were administered in the previous trial.'}], 'secondaryOutcomes': [{'measure': 'Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes)', 'timeFrame': 'at 6 and 12 months', 'description': 'clinical examination'}, {'measure': 'Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area', 'timeFrame': 'at 6 and 12 months', 'description': 'recording of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Actinic Keratosis']}, 'descriptionModule': {'briefSummary': 'Determine the recurrence rate of actinic keratosis (AK) lesions in patients with complete clinical clearance at the end of the previous trial SP848-AK-1101 at 6 and 12 months of follow-up.', 'detailedDescription': 'Efficacy Evaluation:\n\n• Primarily based on clinical inspection of the former 25 cm2 treatment area and count of the AK-lesions.\n\nSafety Evaluation:\n\n* Evaluation of adverse events (AEs) and serious adverse events (SAEs)\n* Evaluation of newly occurred dermal adverse events (AEs) and serious adverse events (SAEs) in the previous treatment area at 6 months and 12 months of follow-up (local tolerability).\n* Follow-up of unresolved adverse and serious adverse events that occurred in the previous trial SP848-AK-1101.\n* Follow-up of unresolved abnormal laboratory values that occurred in the previous trial SP848-AK-1101.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with complete clinical clearance (i.e. no previously existing AK-lesion present) at the end of the trial SP848-AK-1101 or Non- Responder who withdrew from the trial prematurely.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent.\n* Participation in the previous clinical trial SP848-AK-1101.\n* Patient with complete clinical clearance (i.e. no previously existing AK-lesion present) at the end of the trial SP848-AK-1101 or Non-Responder who withdrew from the trial prematurely.\n\nExclusion Criteria:\n\n* Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., cardiovascular, immunological, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, infectious, gastrointestinal abnormalities or diseases).\n* Evidence of systemic cancer.\n* Dermatological disease or condition in the former treatment or surrounding area that might impair trial assessments (e.g., rosacea, atopic dermatitis, eczema) as assessed by the investigator.'}, 'identificationModule': {'nctId': 'NCT01806961', 'briefTitle': 'Observational Trial Tolerability and Efficacy of Resiquimod Gel in Patients Treated for Actinic Keratosis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spirig Pharma Ltd.'}, 'officialTitle': 'Observational (Non-interventional), Follow-up Trial Assessing Long-term Local Tolerability and Efficacy (Recurrence Rate) of Resiquimod Gel in Patients Treated for Actinic Keratosis.', 'orgStudyIdInfo': {'id': 'SP848-AKEx-1209'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'clearance at end of trial SP848-AK-1101', 'description': 'no trial medication during this follow-up trial'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Hauttumorcentrum Charité (HTCC)', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'Medizinisches Zentrum Bonn - Friedensplatz', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Hautzentrum', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Minden', 'country': 'Germany', 'facility': 'Johannes Wesling Klinikum Minden', 'geoPoint': {'lat': 52.28953, 'lon': 8.91455}}, {'city': 'Recklinghausen', 'country': 'Germany', 'facility': 'KLINIKUM VEST GmbH Knappschaftskrankenhaus', 'geoPoint': {'lat': 51.61379, 'lon': 7.19738}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'Universitätsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Kantonsspital St.Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitaetsspital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Lars E French, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Clinic of Dermatology, Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spirig Pharma Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}