Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-01 @ 9:46 PM
Study NCT ID:
NCT00944632
Status:
COMPLETED
Last Update Posted:
2023-06-07
First Post:
2009-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C546413', 'term': 'R-1,1,1-trifluoro-4-(5-fluoro-2,3-dihydrobenzofuran-7-yl)-4-methyl-2-(((2-methyl-5-quinolyl)amino)methyl)pentan-2-ol'}]}}, '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': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2010-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-05', 'studyFirstSubmitDate': '2009-07-22', 'studyFirstSubmitQcDate': '2009-07-22', 'lastUpdatePostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation', 'timeFrame': 'up to 4 weeks'}], 'secondaryOutcomes': [{'measure': "Investigator's Global Assessment of target area", 'timeFrame': 'up to 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of three concentrations of ZK 245186 ointment and vehicle on increasing body surface areas for the treatment of atopic dermatitis and to obtain dose-response information for the three concentrations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of atopic dermatitis (Hanifin and Rajka criteria)\n* mild to moderate atopic dermatitis at beginning of study\n* wash-out periods for systemic and topical treatments for atopic dermatitis\n* females must use effective contraception\n\nExclusion Criteria:\n\n* pregnant or lactating women\n* conditions that in the opinion of the investigator may pose a risk or interfere with the evaluation of the study\n* wide-spread atopic dermatitis requiring systemic treatment\n* diagnosed with immunocompromised status\n* skin diseases - other than atopic dermatitis - in the treatment area\n* mental handicap or legally incompetent'}, 'identificationModule': {'nctId': 'NCT00944632', 'briefTitle': 'Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Double-blind, Randomized, Dose Escalation Study of the Efficacy and Safety of ZK 245186 Ointment in Concentrations of 0.01%, 0.03%, and 0.1% Over 4 Weeks in Patients With Atopic Dermatitis', 'orgStudyIdInfo': {'id': '14501'}, 'secondaryIdInfos': [{'id': '1402942', 'type': 'OTHER', 'domain': 'Company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Zk 245186 0.01% ointment', 'description': 'Active treatment, lowest dose', 'interventionNames': ['Drug: ZK 245186']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ZK 245186 0.03% ointment', 'description': 'Active comparator middle dose', 'interventionNames': ['Drug: ZK 245186']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ZK 245186 0.1% ointment', 'description': 'Active comparator highest dose', 'interventionNames': ['Drug: ZK 245186']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle ointment', 'description': 'Placebo comparator', 'interventionNames': ['Drug: Placebo (vehicle ointment)']}], 'interventions': [{'name': 'ZK 245186', 'type': 'DRUG', 'description': 'Once daily topical non-occlusive application for up to 4 weeks', 'armGroupLabels': ['ZK 245186 0.03% ointment', 'ZK 245186 0.1% ointment', 'Zk 245186 0.01% ointment']}, {'name': 'Placebo (vehicle ointment)', 'type': 'DRUG', 'description': 'Once daily topical non-occlusive application for up to 4 weeks', 'armGroupLabels': ['Vehicle ointment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9301', 'city': 'Bloemfontein', 'country': 'South Africa', 'facility': 'PAREXEL International (Bloemfontein)', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'zip': '6529', 'city': 'George', 'country': 'South Africa', 'facility': 'PAREXEL International (George)', 'geoPoint': {'lat': -33.963, 'lon': 22.46173}}, {'zip': '6045', 'city': 'Newton Park', 'country': 'South Africa', 'facility': 'PAREXEL International (Port Elizabeth)', 'geoPoint': {'lat': -33.94702, 'lon': 25.56534}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}