Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-02 @ 7:57 AM
Study NCT ID:
NCT00942604
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2009-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C486592', 'term': '3-ingenyl angelate'}, {'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'torsten.skov@leo-pharma.com', 'phone': '+4520736294', 'title': 'Dr. Torsten Skov', 'organization': 'LEO Pharma'}, 'certainAgreement': {'otherDetails': 'For US sites: The institution and investigator agree not to publish the results of this study without prior written consent of the Sponsor. As used herein, the term "publish" shall include oral presentations,written abstracts, written manuscripts, etc.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '57 days', 'eventGroups': [{'id': 'EG000', 'title': 'PEP005 (Ingenol Mebutate) Gel', 'description': 'PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days', 'otherNumAtRisk': 100, 'otherNumAffected': 18, 'seriousNumAtRisk': 100, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel once daily for 2 consecutive days', 'otherNumAtRisk': 103, 'otherNumAffected': 1, 'seriousNumAtRisk': 103, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Application site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEP005 (Ingenol Mebutate) Gel', 'description': 'PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel once daily for 2 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '57 days', 'description': 'Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEP005 (Ingenol Mebutate) Gel', 'description': 'PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel once daily for 2 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '57 days', 'description': 'Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PEP005 (Ingenol Mebutate) Gel', 'description': 'PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days'}, {'id': 'FG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel once daily for 2 consecutive days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Patient relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study period was 22 July 2009 (first patient randomized) to 14 October 2009 (last patient completed Day 57).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PEP005 (Ingenol Mebutate) Gel', 'description': 'PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days'}, {'id': 'BG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel once daily for 2 consecutive days'}, {'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': '48', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'dispFirstSubmitDate': '2010-09-22', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-18', 'studyFirstSubmitDate': '2009-07-19', 'dispFirstSubmitQcDate': '2010-09-22', 'resultsFirstSubmitDate': '2012-02-21', 'studyFirstSubmitQcDate': '2009-07-19', 'dispFirstPostDateStruct': {'date': '2010-09-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-21', 'studyFirstPostDateStruct': {'date': '2009-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions', 'timeFrame': '57 days', 'description': 'Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions', 'timeFrame': '57 days', 'description': 'Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peplin', 'Actinic keratosis', 'PEP005'], 'conditions': ['Actinic Keratoses']}, 'referencesModule': {'references': [{'pmid': '22417254', 'type': 'DERIVED', 'citation': 'Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/', 'label': 'Food and Drug Authority'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be male or female and at least 18 years of age.\n* Female patients must be of:\n* Non-childbearing potential;\n* Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception.\n* 4 to 8 AK lesions on non-head locations.\n\nExclusion Criteria:\n\n* Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.\n* Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks.\n* Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 8 weeks and 2 cm of treatment area'}, 'identificationModule': {'nctId': 'NCT00942604', 'briefTitle': 'A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Peplin'}, 'officialTitle': 'A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05%, In Patients With Actinic Keratoses on Non-head Locations (REGION-Ib)', 'orgStudyIdInfo': {'id': 'PEP005-028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PEP005 (ingenol mebutate) Gel', 'description': 'PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days', 'interventionNames': ['Drug: PEP005 (ingenol mebutate) Gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle gel', 'description': 'Vehicle gel once daily for 2 consecutive days', 'interventionNames': ['Drug: Vehicle gel']}], 'interventions': [{'name': 'PEP005 (ingenol mebutate) Gel', 'type': 'DRUG', 'description': 'two day treatment', 'armGroupLabels': ['PEP005 (ingenol mebutate) Gel']}, {'name': 'Vehicle gel', 'type': 'DRUG', 'description': 'two day treatment', 'armGroupLabels': ['Vehicle gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71913', 'city': 'Hot Springs', 'state': 'Arizona', 'country': 'United States', 'facility': 'Burke Pharmaceutical Research'}, {'zip': '92117', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Skin Surgery Medical Group Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '30022', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Dermatology, Vein & Research Center, LLC', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Altman Dermatology Associates', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '60089', 'city': 'Buffalo Grove', 'state': 'Illinois', 'country': 'United States', 'facility': 'Glazer Dermatology', 'geoPoint': {'lat': 42.15141, 'lon': -87.95979}}, {'zip': '47713', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Deaconess Clinic Downtown', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretzin Clinical Research Group, LLC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '68144', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Skin Specialists, PC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89002', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Karl G. Heine Dermatology', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Group Health Associates', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'DermResearch, Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77056', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Suzanne Bruce and Associates, PA, The Center for Skin Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermatology Clinical Research Center of San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '75703', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermatology Associates of Tyler', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Dermatology Research Center, Inc.', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Education and Research Foundation', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Clinical Research, Inc', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peplin', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}