Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-30 @ 6:07 AM
Study NCT ID:
NCT01020994
Status:
COMPLETED
Last Update Posted:
2010-07-09
First Post:
2009-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of LAS41003 in the Treatment of Superficial Infected Eczema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C034213', 'term': 'octenidine'}]}}, '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': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-08', 'studyFirstSubmitDate': '2009-11-24', 'studyFirstSubmitQcDate': '2009-11-25', 'lastUpdatePostDateStruct': {'date': '2010-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combination of clinical and microbial treatment success', 'timeFrame': 'Day 14'}], 'secondaryOutcomes': [{'measure': 'Safety:Physical examination at EoT, AEs/SAEs during the entire study', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Superficial infected eczema', 'Superinfected eczema'], 'conditions': ['Eczema']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine the efficacy and safety of topical application of LAS41003 in comparison to LAS189962 and LAS189961 in the treatment of superinfected eczema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically diagnosed super-infected or impetiginized eczema\n\nExclusion Criteria:\n\n* Patients who have general signs of systemic infections like fever, malaise, lymphangitis or swollen lymph nodes and / or need systemic antibiotic treatment\n* Patients who have a bacterial skin infection which, due to depth and severity, could not be appropriately treated with a topical antimicrobial or antiseptic medication\n* Diagnose of the following disease:\n\n * Known active tuberculosis or any history of past tuberculosis of skin\n * Suspected or proven parasitic infection of the treatment site (e.g. scabies)\n * Psoriasis\n * Suspected or proven viral infection of skin (e.g. Herpes)\n* Localization of the superficial infected eczema:\n\n * Palms of the hands\n * Sole of a foot\n * Face\n* Have received any topical treatment with antibiotics, antimycotics, immunomodulators and corticosteroid preparations within the last 2 weeks before treatment with IMP'}, 'identificationModule': {'nctId': 'NCT01020994', 'briefTitle': 'Efficacy and Safety of LAS41003 in the Treatment of Superficial Infected Eczema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Almirall, S.A.'}, 'officialTitle': 'Explorative, Double-blind, Randomized, Controlled Multi-center Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41003 Once Daily Versus LAS189962 and LAS189961 in the Treatment of Superficial Infected Eczema', 'orgStudyIdInfo': {'id': 'H 552 000 - 0911'}, 'secondaryIdInfos': [{'id': 'EudraCT: 2009-011931-11'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LAS41003', 'interventionNames': ['Drug: LAS41003']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LAS189962', 'interventionNames': ['Drug: LAS189962']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LAS189961', 'interventionNames': ['Drug: LAS189961']}], 'interventions': [{'name': 'LAS41003', 'type': 'DRUG', 'description': 'Once daily, topically', 'armGroupLabels': ['LAS41003']}, {'name': 'LAS189962', 'type': 'DRUG', 'description': 'Once daily, topically', 'armGroupLabels': ['LAS189962']}, {'name': 'LAS189961', 'type': 'DRUG', 'description': 'Once daily, topically', 'armGroupLabels': ['LAS189961']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bochum', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}], 'overallOfficials': [{'name': 'Christoph Willers, MD, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Almirall Hermal GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Almirall, S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Head of Global Clinical Development', 'oldOrganization': 'Almirall Hermal GmbH'}}}}