Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-29 @ 9:04 PM
Study NCT ID:
NCT00747032
Status:
WITHDRAWN
Last Update Posted:
2012-05-07
First Post:
2008-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study withdrawn due to business decisions. No subjects were treated.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-04', 'studyFirstSubmitDate': '2008-09-01', 'studyFirstSubmitQcDate': '2008-09-03', 'lastUpdatePostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in plaque elevation score', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Reduction in Investigator´s Global Evaluation, erythema and scaling scores', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to assess the efficacy of NYC-0462 Ointment in the Treatment of Plaque Psoriasis.Treatment medication will be administered as follows: A thin layer of study product will be applied to the affected skin, excluding the face, once daily, at approximately the same time daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of stable, symptomatic plaque psoriasis\n* Good health with the exception of psoriasis\n* % BSA and plaque elevation requirements\n\nExclusion Criteria:\n\n* Subjects who are pregnant, nursing or planning a pregnancy within the study participation period.\n* Subjects who have any systemic or dermatological disorders with the exception of psoriasis'}, 'identificationModule': {'nctId': 'NCT00747032', 'briefTitle': 'To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nycomed'}, 'officialTitle': 'Multi-Center, Double-Blind, Randomized, Vehicle-controlled, Parallel-Group Study Comparing NYC-0462 Ointment To a Vehicle Control', 'orgStudyIdInfo': {'id': 'NYC 0462-01-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'NYC 0462 Ointment', 'interventionNames': ['Drug: NYC 0462 Ointment']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NYC 0462 Ointment', 'type': 'DRUG', 'description': 'To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kathleen Ocasio', 'role': 'STUDY_CHAIR', 'affiliation': 'Fougera Pharmaceuticals Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fougera Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Kathleen Ocasio', 'oldOrganization': 'Nycomed US Inc.'}}}}