Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-09 @ 5:04 AM
Study NCT ID:
NCT00668733
Status:
COMPLETED
Last Update Posted:
2010-07-20
First Post:
2008-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}, {'id': 'D012871', 'term': 'Skin Diseases'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sharon.levy@gracewaypharma.com', 'phone': '267-948-0400', 'title': 'Sharon F. Levy, MD / Sr. VP, Clinical Product Development', 'organization': 'Graceway Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'All AEs that were ongoing or started in the previous treatment area at the end of Phase 3 study, or any AEs that occurred that were related to the previous Phase 3 study medication were recorded.', 'eventGroups': [{'id': 'EG000', 'title': '2-Week Treatment Group', 'description': 'Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study \\[EOS\\]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.', 'otherNumAtRisk': 89, 'otherNumAffected': 3, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '3-Week Treatment Group', 'description': 'Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study \\[EOS\\]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.', 'otherNumAtRisk': 90, 'otherNumAffected': 0, 'seriousNumAtRisk': 90, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Recurrence of AK Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2-Week Treatment Group', 'description': 'Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study \\[EOS\\]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.'}, {'id': 'OG001', 'title': '3-Week Treatment Group', 'description': 'Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study \\[EOS\\]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to one year', 'description': 'The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were conducted on the evaluable subject population defined as all subjects who were eligible and enrolled in the follow-up study. All results were summarized overall and by original Phase 3 randomized treatment regimen and dose group. Actinic keratosis recurrence was categorized by presence or absence only.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2-Week Treatment Group', 'description': 'Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study \\[EOS\\]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.'}, {'id': 'FG001', 'title': '3-Week Treatment Group', 'description': 'Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study \\[EOS\\]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'This was a Phase 3b longitudinal and observational study.', 'preAssignmentDetails': 'Subjects previously enrolled in studies GW01-0702, GW01-0703, GW01-0704, or GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study \\[EOS\\]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '2-Week Treatment Group', 'description': 'Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study \\[EOS\\]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.'}, {'id': 'BG001', 'title': '3-Week Treatment Group', 'description': 'Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study \\[EOS\\]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '64.0', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '64.5', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-13', 'studyFirstSubmitDate': '2008-04-24', 'resultsFirstSubmitDate': '2010-06-15', 'studyFirstSubmitQcDate': '2008-04-24', 'lastUpdatePostDateStruct': {'date': '2010-07-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-06-15', 'studyFirstPostDateStruct': {'date': '2008-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Recurrence of AK Lesions', 'timeFrame': 'Up to one year', 'description': 'The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Actinic keratoses', 'Dermatologic disease'], 'conditions': ['Actinic Keratoses']}, 'referencesModule': {'references': [{'pmid': '21283921', 'type': 'DERIVED', 'citation': 'Hanke CW, Swanson N, Bruce S, Berman B, Kulp J, Levy S. Complete clearance is sustained for at least 12 months after treatment of actinic keratoses of the face or balding scalp via daily dosing with imiquimod 3.75% or 2.5% cream. J Drugs Dermatol. 2011 Feb;10(2):165-70.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to obtain long-term sustained clearance rates for subjects previously treated with imiquimod creams in studies GW01-0702, GW01-0703, GW01-0704 and GW01-0705.', 'detailedDescription': 'This is a Phase 3 longitudinal and observational study. Subjects who previously enrolled in studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705 and were completely cleared of their AK lesions in the selected treatment area at the end-of-study visit will return for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.\n\nThe NCT numbers for the above mentioned studies are:\n\nNCT00603798 - for Studies GW01-0703 and GW01-0705\n\nNCT00605176 for Studies GW01-0702 and GW01-0704'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consisted of subjects who have been treated with imiquimod or with placebo in one of the aformentioned studies and who demonstrated complete clearance of all clinically visible or palpable AK lesions in the selected treatment area at the end-of-study visit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are willing and able to give informed consent;\n* Have successfully completed one of the following studies: GW01-0702, GW01- 0703, GW01-0704, or GW01-0705 and have been determined to be completely clear of AK lesions at the EOS visit in the designated treatment area from the previous study\n* Are willing to participate in the study as an outpatient, make visits to the study center for follow-up evaluation, and agree to comply with all study requirements.\n\nExclusion Criteria:\n\n* None. All subjects who meet the inclusion criteria above may participate.'}, 'identificationModule': {'nctId': 'NCT00668733', 'briefTitle': 'Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year', 'organization': {'class': 'INDUSTRY', 'fullName': 'Graceway Pharmaceuticals, LLC'}, 'officialTitle': 'Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year After Completion of Studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705', 'orgStudyIdInfo': {'id': 'GW01-0803'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sharon Levy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Graceway Pharmaceuticals, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Graceway Pharmaceuticals, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Sharon Levy, MD / Vice President, Product Development', 'oldOrganization': 'Graceway Pharmaceuticals, LLC'}}}}