Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT00915551
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2009-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Multi-Center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
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, 0.015%', 'description': 'PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days', 'otherNumAtRisk': 142, 'otherNumAffected': 20, 'seriousNumAtRisk': 142, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel once daily for 3 consecutive days', 'otherNumAtRisk': 136, 'otherNumAffected': 1, 'seriousNumAtRisk': 136, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'Hip Arthroplasty (Hip Replacement)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complete Clearance of Actinic Keratoses (AK) Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEP005 (Ingenol Mebutate) Gel, 0.015%', 'description': 'PEP005 (Ingenol Mebutate) gel, 0.015% once daily for 3 consecutive days'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel once daily for 3 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'upperLimit': '55.7'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '10.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and 57 days', 'description': 'Complete clearance of the treatment field', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'Partial Clearance of Actinic Keratoses (AK)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEP005 (Ingenol Mebutate) Gel, 0.015%', 'description': 'PEP005 (Ingenol Mebutate) gel, 0.015% once daily for 3 consecutive days'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel once daily for 3 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and 57 days', 'description': 'Partial clearance defined as ≥ 75% reduction in the number of 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, 0.015%', 'description': 'PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days'}, {'id': 'FG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel once daily for 3 consecutive days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Study PEP005-025 was conducted at 21 study centers in the United States (19) and Australia (2). A total of 278 patients were randomized (255 (92%) in the US and 23 (8%) in Australia). Patient screening was started on 05 May 2009. The first patient was randomized on 05 June 2009 and the last patient completed the Day 57 visit on 02 September 2009.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PEP005 (Ingenol Mebutate) Gel, 0.015%', 'description': 'PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days'}, {'id': 'BG001', 'title': 'Vehicle Gel', 'description': 'Vehicle gel once daily for 3 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': '73', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', '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': 278}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'dispFirstSubmitDate': '2010-09-22', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-18', 'studyFirstSubmitDate': '2009-06-04', 'dispFirstSubmitQcDate': '2010-09-22', 'resultsFirstSubmitDate': '2012-02-21', 'studyFirstSubmitQcDate': '2009-06-05', 'dispFirstPostDateStruct': {'date': '2010-09-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-21', 'studyFirstPostDateStruct': {'date': '2009-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Clearance of Actinic Keratoses (AK) Lesions', 'timeFrame': 'baseline and 57 days', 'description': 'Complete clearance of the treatment field'}], 'secondaryOutcomes': [{'measure': 'Partial Clearance of Actinic Keratoses (AK)', 'timeFrame': 'baseline and 57 days', 'description': 'Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peplin', 'Actinic keratosis', 'PEP005'], 'conditions': ['Actinic Keratosis']}, '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'}, {'url': 'http://www.tga.gov.au', 'label': 'Therapeutic Goods Administration'}]}, 'descriptionModule': {'briefSummary': 'This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is male or female and at least 18 years of age\n* Female patients must be of either:\n\n * Non-childbearing potential, post-menopausal\n * Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy\n\nExclusion Criteria:\n\n* Cosmetic or therapeutic procedures within 2 weeks and 2cm 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 the selected treatment area'}, 'identificationModule': {'nctId': 'NCT00915551', 'briefTitle': 'A Multi-Center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)', '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, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIb)', 'orgStudyIdInfo': {'id': 'PEP005-025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEP005 (Ingenol Mebutate) gel', 'interventionNames': ['Drug: PEP005 (Ingenol Mebutate) gel, 0.015%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle gel', 'interventionNames': ['Drug: Vehicle Gel']}], 'interventions': [{'name': 'PEP005 (Ingenol Mebutate) gel, 0.015%', 'type': 'DRUG', 'description': 'once daily for 3 consecutive days', 'armGroupLabels': ['PEP005 (Ingenol Mebutate) gel']}, {'name': 'Vehicle Gel', 'type': 'DRUG', 'description': 'once daily for 3 consecutive days', 'armGroupLabels': ['Vehicle gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71913', 'city': 'Hot Springs', 'state': 'Arizona', 'country': 'United States', 'facility': 'Burke Pharmaceutical Research'}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Center for Dermatology', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'North Florida Dermatology Associates, PA', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Altman Dermatology Associates', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Laser Skin Surgery Center of Indiana', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '47713', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Deaconess Clinic, Inc', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '46168', 'city': 'Plainfield', 'state': 'Indiana', 'country': 'United States', 'facility': 'The Indiana Clinical Trials Center, PC', 'geoPoint': {'lat': 39.70421, 'lon': -86.39944}}, {'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': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Academic Dermatology Associates', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10029-6574', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Dermatology Associates of Rochester, PC', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dermatology, Laser Vein Specialists of the Carolinas', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '97223', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Medical Research Center, PC', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'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': 'Progressive Clinical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Education and Research Foundation', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Premier Clinical Research', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '4217', 'city': 'Benowa', 'state': 'Queensland', 'country': 'Australia', 'facility': 'The Skin Centre', 'geoPoint': {'lat': -28.0077, 'lon': 153.38583}}, {'zip': '4152', 'city': 'Carina Heights', 'state': 'Queensland', 'country': 'Australia', 'facility': 'South East Dermatology, Belmont Specialist Centre', 'geoPoint': {'lat': -27.50721, 'lon': 153.09126}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peplin', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}