Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-28 @ 3:51 PM
Study NCT ID:
NCT00427050
Status:
COMPLETED
Last Update Posted:
2015-09-14
First Post:
2007-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C486592', 'term': '3-ingenyl angelate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-11', 'studyFirstSubmitDate': '2007-01-24', 'studyFirstSubmitQcDate': '2007-01-24', 'lastUpdatePostDateStruct': {'date': '2015-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimal tolerated regime of PEP005 Topical Gel in patients, when administered as either two day or three day application schedules to a 25 cm2 contiguous AK treatment area on the face or face and scalp'}], 'secondaryOutcomes': [{'measure': 'Efficacy at 2 or 3day application PEP005 Topical Gel at the MTD of 0.025% in the Expanded Cohort, and at 2 lower concs of 0.0175% and 0.0125% at either a 2 or 3day application, when applied to 25cm2 AK treatment area on face or face/scalp.'}]}, 'conditionsModule': {'keywords': ['Actinic Keratoses (AK)', 'PEP005', 'Topical', 'Dermatology'], 'conditions': ['Actinic Keratoses']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bellberry.com.au', 'label': 'Central HREC'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the optimal tolerated regime of PEP005 for the treatment of actinic keratoses of the face or face and scalp.', 'detailedDescription': 'Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Male patients at least 18 years of age.\n2. Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.\n3. Four to eight clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or face and scalp.\n\n5\\. Ability to follow study instructions and likely to complete all study requirements.\n\n6\\. Written informed consent has been obtained. 7. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study data package.'}, 'identificationModule': {'nctId': 'NCT00427050', 'briefTitle': 'A Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel', 'organization': {'class': 'INDUSTRY', 'fullName': 'Peplin'}, 'officialTitle': 'An Open-label, Multi-centre, Dose-escalation, Cohort Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel When Applied to a 25 cm2 Contiguous Actinic Keratoses Treatment Area on the Face or Face and Scalp.', 'orgStudyIdInfo': {'id': 'PEP005-007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PEP005', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Skin and Cancer Foundation', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Southderm Pty Ltd', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '2217', 'city': 'Level 3, 22 Belgrave St, Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'St George Dermatology and Skin Cancer Centre', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '4152', 'city': 'Belmont Specialist Centre, 1202 Creek Rd, Carina Heights', 'state': 'Queensland', 'country': 'Australia', 'facility': 'South East Dermatology', 'geoPoint': {'lat': -27.50721, 'lon': 153.09126}}, {'zip': '4217', 'city': 'Benowa', 'state': 'Queensland', 'country': 'Australia', 'facility': 'The Skin Centre', 'geoPoint': {'lat': -28.0077, 'lon': 153.38583}}, {'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Siller Medical', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Epsom', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland Dermatology', 'geoPoint': {'lat': -36.88745, 'lon': 174.77059}}, {'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Tristram Clinic', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'city': 'Tauranga', 'country': 'New Zealand', 'facility': 'Skin Centre', 'geoPoint': {'lat': -37.68611, 'lon': 176.16667}}], 'overallOfficials': [{'name': 'Janelle Katsamas', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peplin Operations Pty Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peplin', 'class': 'INDUSTRY'}}}}