A Pilot Study of Topical Antiflammin-2 for Psoriasis

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Nctid: NCT00001371

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011565", "term"=>"Psoriasis"}], "ancestors"=>[{"id"=>"D000017444", "term"=>"Skin Diseases, Papulosquamous"}, {"id"=>"D000012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M10293", "name"=>"Inflammation", "relevance"=>"LOW"}, {"id"=>"M14422", "name"=>"Psoriasis", "asFound"=>"Psoriasis", "relevance"=>"HIGH"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M19713", "name"=>"Skin Diseases, Papulosquamous", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "enrollmentInfo"=>{"count"=>24}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1993-12"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-12", "completionDateStruct"=>{"date"=>"2000-12"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"2002-12-09", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2002-12-10", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Inflammation", "Lipocortin", "Phospholipase A-2", "Skin", "Uteroglobin", "Psoriasis"], "conditions"=>["Psoriasis"]}, "descriptionModule"=>{"briefSummary"=>"This study is a pilot trial designed to evaluate topical antiflammin-2, a phospholipase A2 (PLA2) inhibitor, in the treatment of chronic plaque psoriasis. Antiflammin-2 in an ointment base, or the vehicle alone will each be applied four times per day to a single plaque in a randomized, double-blinded fashion.", "detailedDescription"=>"This study is a pilot trial designed to evaluate topical antiflammin-2, a phospholipase A2 (PLA2) inhibitor, in the treatment of chronic plaque psoriasis. Antiflammin-2 in an ointment base, or the vehicle alone will each be applied four times per day to a single plaque in a randomized, double-blinded fashion."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Patients must be age 18 or older.\n\nPatients male or female must use contraception if of childbearing age. No men and women actively attempting to conceive a child during the time of drug testing. No pregnant or nursing women.\n\nPatients must be otherwise healthy, immunocompetent, ambulatory patients with psoriasis who have more than 5 percent of their body surface area involved with the disease or who have localized disabling psoriasis.\n\nHave failed one prior topical treatment regimen including topical cortiscosteroids, coat tar preparations, or ultraviolet light.\n\nAn ambulatory performance status of 0,1,2 (ECOG Scale).\n\nAbility to participate in an out -patient study and to provide informed consent.\n\nCreatinine less than 2.0 mg/100ml. Bilirubin less than or equal to 1.5 mg/100ml; prothrombin time less than or equal to 1.3 times control. WBC greater than 3000/mm(3), granulocytes greater than 1500/mm(3), platelets greater than 100,000/mm(3).\n\nNo clinically significant cardiac disease.\n\nNo patients with previously documented serious infectious diseases such as pneumocystis pneumonia, mycobacterium avium infection, etc. which would suggest clinically evident immunodeficiency.\n\nNo systemic treatment for psoriasis (methotrexate, PUVA, UVB, cyclosporine, etc.) and topical treatments (corticosteroids, tar, anthralin, etc.) during the four weeks prior to study entry, and topical treatment during the two weeks prior to study entry."}, "identificationModule"=>{"nctId"=>"NCT00001371", "briefTitle"=>"A Pilot Study of Topical Antiflammin-2 for Psoriasis", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Pilot Study of Topical Antiflammin-2 for Psoriasis", "orgStudyIdInfo"=>{"id"=>"940048"}, "secondaryIdInfos"=>[{"id"=>"94-C-0048"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Cancer Institute (NCI)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}}}}