Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT00953732
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2009-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-25', 'studyFirstSubmitDate': '2009-08-04', 'studyFirstSubmitQcDate': '2009-08-05', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summarize treatment area recurrence of AK lesions, in the selected treatment area', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Summarize long-term safety data(incidence of AEs in the treatment area)', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peplin', 'Actinic keratosis', 'PEP005'], 'conditions': ['Actinic Keratosis']}, 'referencesModule': {'references': [{'pmid': '23553119', 'type': 'DERIVED', 'citation': 'Lebwohl M, Shumack S, Stein Gold L, Melgaard A, Larsson T, Tyring SK. Long-term follow-up study of ingenol mebutate gel for the treatment of actinic keratoses. JAMA Dermatol. 2013 Jun;149(6):666-70. doi: 10.1001/jamadermatol.2013.2766.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov', 'label': 'Food and Drug Authority'}, {'url': 'http://www.tga.gov.au', 'label': 'Therapeutic Goods Administration'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to follow up patients who have achieved complete clearance of AK lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.', 'detailedDescription': 'A 12 month long-term follow-up study of patients who have achieved complete clearance of AK lesions at the Day 57 in the Phase 3 studies PEP005-016 or PEP005-025.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients must have achieved complete clearance of AK lesions at Day 57 visit in either study PEP005-016 or PEP005-025 will be offered participation in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must have achieved complete clearance of AK lesions (lesion count = 0) at Day 57 in one of the following Peplin AK clinical studies: PEP005-016 or PEP005-025\n* Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures\n\nExclusion Criteria:\n\n* Concurrent participation in another research study which would involve the selected treatment area (except for any post-study follow-up visits for previous Peplin AK study)\n* Early termination from study PEP005-016 or PEP005-025'}, 'identificationModule': {'nctId': 'NCT00953732', 'briefTitle': 'A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Peplin'}, 'officialTitle': 'A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on the Head (Face or Scalp) Who Have Completed Day 57 in Studies PEP005-016 or PEP005-025 (REGION IIa and IIb)', 'orgStudyIdInfo': {'id': 'PEP005-030'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'interventionNames': ['Drug: Lesion count']}], 'interventions': [{'name': 'Lesion count', 'type': 'DRUG', 'otherNames': ['AK lesion recurrence'], 'description': 'Lesion count in area treated by study drug in a prior study. No drug will be applied during this long-term follow up study. Drug was applied during the primary study.', 'armGroupLabels': ['1']}]}, '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': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Research Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Specialists Inc', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92117', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Skin Surgery Medical Group Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94114', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Conant Medical Group', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'North Florida Dermatology Associates, PA', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami, Skin Research Camp', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30022', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Dermatology, Vein & Research Center, LLC', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '30263', 'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medaphase Inc', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'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': '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': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretein Clinical Research Group, LLC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46168', 'city': 'Plainfield', 'state': 'Indiana', 'country': 'United States', 'facility': 'The Indiana Clinical Trials Center, PC', 'geoPoint': {'lat': 39.70421, 'lon': -86.39944}}, {'zip': '42301', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pedia Research LLC', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '48059', 'city': 'Fort Gratiot', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hamzavi Dermatology'}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Clinical Study Center', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'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': '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': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research Associates', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '97223', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Medical Research', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Dermatology Research Associates', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'DermResearch, Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77845', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'J & S Studies, Inc.', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '77056', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Suzanne Bruce and Associates, 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': '75703', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermatology Associates of Tyler', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Clinical Studies', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'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}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Premier Clinical Research', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Southderm Pty Ltd', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'St George Dematology and Skin Cancer Centre', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'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}}], 'overallOfficials': [{'name': 'Eugene Bauer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chief Medical Officer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peplin', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'TKL Research, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}