Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-28 @ 12:19 PM
Study NCT ID:
NCT00991861
Status:
COMPLETED
Last Update Posted:
2015-05-29
First Post:
2009-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-28', 'studyFirstSubmitDate': '2009-10-07', 'studyFirstSubmitQcDate': '2009-10-07', 'lastUpdatePostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histological clearance of one pre-selected target lesion', 'timeFrame': 'Day 120'}, {'measure': 'Complete clinical clearance of all target lesions in the treatment areas', 'timeFrame': 'Day 120'}], 'secondaryOutcomes': [{'measure': "Physician's Global Tolerability Assessment (PGT)", 'timeFrame': 'Day 120'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Actinic Keratosis', 'AK', 'NMSC'], 'conditions': ['Actinic Keratosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.almirall.com/webcorp2/cda/ImD_04_02.jsp', 'label': 'Almirall Corporate Website'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the efficacy, safety and tolerability of either a once or twice daily topical application of LAS41007 compared to a twice daily application of LAS106521 in the treatment of actinic keratosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 4-10 clinically assessed actinic keratosis grade I to II (according to Olsen et al, 1991) in the face/forehead and/or on the bald scalp\n* The diameter of each AK target lesion is not less than 0.5 cm and not greater than 1.5 cm\n* The target lesions must be located in overall 2 treatment areas with a size of 25 cm2 per treatment area\n\nExclusion Criteria:\n\n* Have evidence of clinically significant or unstable medical conditions such as:\n\n * metastatic tumor or tumor with high probability of metastatic spread\n * heart failure (NYHA class III or higher)\n * immunosuppressive disorder (e.g. HIV)\n * hematologic, hepatic, renal, neurologic or endocrine disorder.\n * collagen-vascular disorder (e.g. cerebrovascular disorder or other bleedings).\n * gastrointestinal disorder (e.g. active ulcera or history of recurrent peptic ulcera or hemorrhage)\n* Suffer from paresthesia in the treatment areas\n* Show Cornu cutaneum of the skin and/or hypertrophic AK lesions in the treatment areas'}, 'identificationModule': {'nctId': 'NCT00991861', 'briefTitle': 'Efficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Almirall, S.A.'}, 'officialTitle': 'Double-blind, Randomized, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41007 Once Daily and LAS41007 Twice Daily Versus LAS106521 Gel Twice Daily in the Treatment of Actinic Keratosis Grade I to II', 'orgStudyIdInfo': {'id': 'H 569 000 - 0908'}, 'secondaryIdInfos': [{'id': 'EudraCT: 2009-012063-33'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LAS41007 o.d.', 'description': 'Once daily', 'interventionNames': ['Drug: LAS41007 o.d.']}, {'type': 'EXPERIMENTAL', 'label': 'LAS41007 b.i.d.', 'description': 'Twice daily', 'interventionNames': ['Drug: LAS41007 b.i.d.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LAS106521', 'interventionNames': ['Drug: LAS106521']}], 'interventions': [{'name': 'LAS41007 o.d.', 'type': 'DRUG', 'description': 'Once daily, topical application', 'armGroupLabels': ['LAS41007 o.d.']}, {'name': 'LAS41007 b.i.d.', 'type': 'DRUG', 'description': 'Twice daily, topical application', 'armGroupLabels': ['LAS41007 b.i.d.']}, {'name': 'LAS106521', 'type': 'DRUG', 'description': 'Twice daily, topical application', 'armGroupLabels': ['LAS106521']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamburg', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Christoph Willers, MD, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Almirall Hermal GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Almirall, S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}