Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-10 @ 3:08 PM
Study NCT ID:
NCT00544258
Status:
COMPLETED
Last Update Posted:
2015-02-12
First Post:
2007-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-11', 'studyFirstSubmitDate': '2007-10-14', 'studyFirstSubmitQcDate': '2007-10-15', 'lastUpdatePostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the extent of systemic absorption of PEP005 when applied as 0.05% Topical Gel on two consecutive days (Day 1 and Day 2) to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of two consecutive days of application of 0.05% PEP005 Topical Gel, when applied to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetic study', 'Actinic Keratosis', 'Topical', 'Dermatology'], 'conditions': ['Actinic Keratoses']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.qimr.edu.au/', 'label': 'Queensland Institute of Medical Research'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the extent of systemic absorption of PEP005 when applied topically for the treatment of actinic keratoses.', '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': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male patients at least 18 years of age.\n2. A contiguous 100 cm2 treatment area containing at least 5 AK lesions, on the either the right or left extensor (dorsal aspect) forearm.\n3. Written informed consent has been obtained.\n4. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study package.'}, 'identificationModule': {'nctId': 'NCT00544258', 'briefTitle': 'Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005', 'organization': {'class': 'INDUSTRY', 'fullName': 'Peplin'}, 'officialTitle': 'A Phase I, Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005, When Applied as 0.05% PEP005 Topical Gel to a 100 cm2 (5 cm x 20 cm) Contiguous Actinic Keratosis(AK) Treatment Area on the Extensor (Dorsal Aspect) Forearm.', 'orgStudyIdInfo': {'id': 'PEP005-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Two days consecutive days of application of 0.05% PEP005 Topical Gel to a 100cm2 contiguous AK treatment area of the arm.', 'interventionNames': ['Drug: PEP005']}], 'interventions': [{'name': 'PEP005', 'type': 'DRUG', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Silverton Place, 101 Wickham Terrace, Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Siller Medical', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}], 'overallOfficials': [{'name': 'Janelle Katsamas', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peplin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peplin', 'class': 'INDUSTRY'}}}}