Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-05 @ 12:55 AM
Study NCT ID:
NCT00659893
Status:
COMPLETED
Last Update Posted:
2015-09-14
First Post:
2008-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2
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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-11', 'studyFirstSubmitDate': '2008-04-15', 'studyFirstSubmitQcDate': '2008-04-16', 'lastUpdatePostDateStruct': {'date': '2015-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability (incidence of AEs, SAEs and skin responses)', 'timeFrame': 'Screening to End of Study (Day 57)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peplin', 'PEP005', 'Actinic Keratosis'], 'conditions': ['Actinic Keratosis']}, 'referencesModule': {'references': [{'pmid': '25584134', 'type': 'DERIVED', 'citation': 'Anderson L, Jarratt M, Schmieder G, Shumack S, Katsamas J, Welburn P. Tolerability and Pharmacokinetics of Ingenol Mebutate 0.05% Gel Applied to Treatment Areas up to 100cm(2) on the Forearm(s) of Patients with Actinic Keratosis. J Clin Aesthet Dermatol. 2014 Dec;7(12):19-29.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov', 'label': 'Food and Drug Administration'}, {'url': 'http://www.tga.gov.au/', 'label': 'Therapeutic Goods Administration'}]}, 'descriptionModule': {'briefSummary': 'Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be male and at least 18 years of age.\n* A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal aspect) forearms, each containing a minimum of 5 AK lesions.\n\nExclusion Criteria:\n\n* Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 weeks and within 2 cm of the selected treatment area(s).\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 within 2 cm of the selected treatment area(s).'}, 'identificationModule': {'nctId': 'NCT00659893', 'briefTitle': 'Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Peplin'}, 'officialTitle': 'A Multi-center, Open Label, Dose-area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s)', 'orgStudyIdInfo': {'id': 'PEP005-022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Cohort 1 One 25 cm2 treatment area; on one arm', 'interventionNames': ['Drug: PEP005 Topical gel']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Cohort 2 One 50cm2 contiguous treatment area; on one arm', 'interventionNames': ['Drug: PEP005 Topical gel']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Cohort 3 Two 25cm2 treatment areas; one on each arm', 'interventionNames': ['Drug: PEP005 Topical gel']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Cohort 4 One 25cm2 treatment area; and one 50cm2 contiguous treatment area; one on each arm', 'interventionNames': ['Drug: PEP005 Topical gel']}, {'type': 'EXPERIMENTAL', 'label': '5', 'description': 'Cohort 5 One 75cm2 contiguous treatment area; on one arm', 'interventionNames': ['Drug: PEP005 Topical gel']}, {'type': 'EXPERIMENTAL', 'label': '6', 'description': 'Cohort 6 Two 50cm2 contiguous treatment area; one on each arm', 'interventionNames': ['Drug: PEP005 Topical gel']}, {'type': 'EXPERIMENTAL', 'label': '7', 'description': 'Cohort 7 One 25cm2 treatment area; and one 75cm2 contiguous treatment area; one on each arm', 'interventionNames': ['Drug: PEP005 Topical gel']}, {'type': 'EXPERIMENTAL', 'label': '8', 'description': 'Cohort 8 One 100cm2 contiguous treatment area; on one arm', 'interventionNames': ['Drug: PEP005 Topical gel']}], 'interventions': [{'name': 'PEP005 Topical gel', 'type': 'DRUG', 'description': '0.05%, two day dose', 'armGroupLabels': ['1', '2', '3', '4', '5', '6', '7', '8']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92117', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Skin Surgery Medical Group Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32073', 'city': 'Orange Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Park Avenue Dermatology', 'geoPoint': {'lat': 30.16607, 'lon': -81.70648}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Dermatology and Cosmetic Surgery', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '33781', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Radiant Research Inc.', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '30263', 'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medaphase Inc', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '08075', 'city': 'Riverside Park', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Karen S. Harkaway, MD LLC', 'geoPoint': {'lat': 40.03844, 'lon': -74.97461}}, {'zip': '77845', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'J&S Studies', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '2217', 'city': 'Kogarah, Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'St George Dematology and Skin and Cancer Centre'}, {'zip': '4152', 'city': 'Carina Heights, Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'South East Dermatology, Belmont Specialist Centre'}, {'zip': '3053', 'city': 'Carlton, Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Skin and Cancer Foundation'}, {'zip': '6008', 'city': 'Subiaco, Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'St John of God Dermatology'}, {'zip': '6100', 'city': 'Victoria Park, Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Burswood Dermatology'}], 'overallOfficials': [{'name': 'George Schmieder, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Park Avenue Dermatology'}, {'name': 'Stephen Shumack, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St George Dermatology and Skin and Cancer Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peplin', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}