Nctid:
NCT00001680
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008180", "term"=>"Lupus Erythematosus, Systemic"}, {"id"=>"D008179", "term"=>"Lupus Erythematosus, Discoid"}], "ancestors"=>[{"id"=>"D003240", "term"=>"Connective Tissue Diseases"}, {"id"=>"D001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D008178", "term"=>"Lupus Erythematosus, Cutaneous"}, {"id"=>"D012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M11176", "name"=>"Lupus Erythematosus, Discoid", "asFound"=>"Discoid Lupus Erythematosus", "relevance"=>"HIGH"}, {"id"=>"M11177", "name"=>"Lupus Erythematosus, Systemic", "asFound"=>"Lupus Erythematosus", "relevance"=>"HIGH"}, {"id"=>"M6464", "name"=>"Connective Tissue Diseases", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M11175", "name"=>"Lupus Erythematosus, Cutaneous", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T1683", "name"=>"Cutaneous Lupus Erythematosus", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D013792", "term"=>"Thalidomide"}], "ancestors"=>[{"id"=>"D007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D007917", "term"=>"Leprostatic Agents"}, {"id"=>"D000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D020533", "term"=>"Angiogenesis Inhibitors"}, {"id"=>"D043924", "term"=>"Angiogenesis Modulating Agents"}, {"id"=>"D006133", "term"=>"Growth Substances"}, {"id"=>"D006131", "term"=>"Growth Inhibitors"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}], "browseLeaves"=>[{"id"=>"M16559", "name"=>"Thalidomide", "asFound"=>"Expression", "relevance"=>"HIGH"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M22318", "name"=>"Angiogenesis Inhibitors", "relevance"=>"LOW"}, {"id"=>"M9231", "name"=>"Growth Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>17}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1997-10"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-09", "completionDateStruct"=>{"date"=>"2001-07"}, "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"=>["Double-masked", "Neuropathy", "Occlusive Dressing", "Pilot", "Placebo"], "conditions"=>["Discoid Lupus Erythematosus"]}, "referencesModule"=>{"references"=>[{"pmid"=>"6838771", "type"=>"BACKGROUND", "citation"=>"Knop J, Bonsmann G, Happle R, Ludolph A, Matz DR, Mifsud EJ, Macher E. Thalidomide in the treatment of sixty cases of chronic discoid lupus erythematosus. Br J Dermatol. 1983 Apr;108(4):461-6. doi: 10.1111/j.1365-2133.1983.tb04600.x."}, {"pmid"=>"8527011", "type"=>"BACKGROUND", "citation"=>"Schuler U, Ehninger G. Thalidomide: rationale for renewed use in immunological disorders. Drug Saf. 1995 Jun;12(6):364-9. doi: 10.2165/00002018-199512060-00002."}, {"pmid"=>"7864692", "type"=>"BACKGROUND", "citation"=>"Gardner-Medwin JM, Smith NJ, Powell RJ. Clinical experience with thalidomide in the management of severe oral and genital ulceration in conditions such as Behcet's disease: use of neurophysiological studies to detect thalidomide neuropathy. Ann Rheum Dis. 1994 Dec;53(12):828-32. doi: 10.1136/ard.53.12.828."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this double-masked, pilot trial is to determine whether 20 percent thalidomide ointment is safe and effective for the treatment of chronic discoid lupus erythematosus (CDLE) when used under an occlusive dressing. Seventeen patients with two similar lesions will have lesions randomized to receive either intervention or placebo therapy.", "detailedDescription"=>"The purpose of this double-masked, pilot trial is to determine whether 20 % thalidomide ointment is safe and effective for the treatment of chronic discoid lupus erythematosus (CDLE) when used under an occlusive dressing. Seventeen patients with two similar lesions will have lesions randomized to receive either intervention or placebo therapy."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Age, 18 or more.\n\nMust have lesions that fulfill clinical and histologic criteria for active CDLE.\n\nLesions must be of at least 3 months duration and must not have been treated with topical steroids or retinoids for at least 3 weeks.\n\nPatient must have at least two similar lesions that can accommodate a 2X3 inch dressing.\n\nPatient must be willing to have two 4 mm biopsies prior to onset of therapy and four 4 mm biopsies at the end of the study period.\n\nIn the absence of systemic involvement, the CDLE lesions must not have responded to at least 3 months of therapy with topical steroids, sunscreens with or without antimalarials such as hydroxychloroquine.\n\nIf CDLE is present in association with systemic involvement, the lesions must not have responded to 3 months of stable conventional systemic therapy and/or topical steroids and sunscreens.\n\nIf female, the patient must have a negative pregnancy test prior to study entry.\n\nIf female, must be postmenopausal surgically sterile, sexually inactive, or practicing successful contraception with two methods of birth control simultaneously for at least one month prior to starting on thalidomide and continue use for another month after the last application of thalidomide.\n\nIf male, the patient must be surgically sterilized, sexually inactive, or use a condom during the study and continue regular use until one month after the last application of thalidomide.\n\nPatients must have normal cognitive abilities to be able to understand the experimental nature of the therapy, to be able to follow instructions regarding application of medication and correct use of contraceptive measures.\n\nPatients must not be pregnant or lactating.\n\nPatients must not have renal disease (serum creatinine greater than 2 times the upper limit of normal.\n\nPatients must not have hepatic dysfunction (liver function tests greater than 2 times the upper limit of normal).\n\nPatients must not have unstable systemic lupus erythematosus such that systemic therapy cannot be maintained at steady doses for the duration of the study.\n\nPatients must not use topical steroids for the duration of the study.\n\nPatients must not be currently receiving systemic thalidomide.\n\nPatients must not be hypersensitive to thalidomide.\n\nPatients must not have presence of polyneuropathy (objective sensory loss or motor weakness or reflex loss) with the exception of focal nerve entrapment syndromes (such as carpal tunnel syndrome), or receiving drugs with known or suspected neuropathic side effects.\n\nPatients must not have any other condition or therapy which in the opinion of the investigators may pose a risk to the patient or confound the results of the study."}, "identificationModule"=>{"nctId"=>"NCT00001680", "briefTitle"=>"A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus", "orgStudyIdInfo"=>{"id"=>"980008"}, "secondaryIdInfos"=>[{"id"=>"98-C-0008"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Thalidomide", "type"=>"DRUG"}]}, "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"}}}}
