[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100139266":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":30,"locations":36,"responsibleParty":48,"collaborators":30,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":30,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":30,"enrollmentInfo":60,"targetDuration":30,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":77,"whyStopped":30,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"U.S. Army Medical Research and Development Command","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Paromomycin Alone Treatment","ACTIVE_COMPARATOR","Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days",[13],"Drug: Paromomycin Alone Cream (15% paromomycin topical cream)",{"label":15,"type":10,"description":16,"interventionNames":17},"WR 279,396","WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days",[18],"Drug: WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream)",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream)","topical application to CL lesions once daily for 20 days",[15],[26],"Topical paromomycin\u002Fgentimicin cream",{"type":21,"name":28,"description":23,"armGroupLabels":29,"otherNames":30},"Paromomycin Alone Cream (15% paromomycin topical cream)",[9],null,[32],{"name":33,"affiliation":34,"role":35},"Nestor Sosa, M.D. FACP","Instituto Conmemorativo Gorgas de Estudios de la Salud","PRINCIPAL_INVESTIGATOR",[37],{"facility":38,"status":30,"city":39,"state":30,"zip":30,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":30},"Gorgas Memorial Institute Clinical Research Unit","Panama City","Panama","PA",{"type":43,"coordinates":44},"Point",[45,46],-79.51973,8.9936,{"lat":46,"lon":45},{"type":49,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100139266","phase-2-pharmacokinetics-safety-and-efficacy-trial-of-wr-279396-paromomycin--gentamicin-topical-cream-and-paromomycin-topical-cream-for-the-treatment-of-cutaneous-leishmaniasis-in-panama-100139266",true,"NCT01083576","Pharmacokinetics, Safety, and Efficacy Trial of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream for the Treatment of Cutaneous Leishmaniasis in Panama","Double-blind, Randomized, Pharmacokinetics, Safety, and Efficacy Trial of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream for the Treatment of Cutaneous Leishmaniasis in Panama","Inclusion Criteria:\n\n* To be eligible for the study, the following must be answered \"YES\" or not applicable, as appropriate for the study subject:\n\n  1. Is the subject a male or female at least 5 years-of-age?\n  2. Is the subject or legal guardian able to give written informed consent or assent, as appropriate?\n  3. Does the subject have a diagnosis of CL in at least one lesion by at least one of the following methods: 1) positive culture for promastigotes, or 2) microscopic identification of amastigotes in stained lesion tissue.\n  4. Does the subject have at least one ulcerative lesion ≥ 1 cm and ≤ 5 cm, that meets the criteria for an index lesion?\n  5. Is the subject willing to forego other forms of treatments for CL including other investigational treatments during the study?\n  6. In the opinion of the investigator, is the subject (or their legal guardian) capable of understanding and complying with the protocol?\n  7. If female and of child-bearing potential, did the subject have a negative pregnancy test during screening and agree to use an acceptable method of birth control during the treatment phase and for 1 month after treatment is completed?\n  8. Does the subject have adequate venous access for blood draws?\n\nExclusion Criteria:\n\nTo be eligible for the study, the following must be answered \"NO\" or not applicable as appropriate for the study subject:\n\n1. Does the subject have only a single lesion whose characteristics include any of the following: verrucous or nodular lesion (non-ulcerative), lesion \\\u003C1 cm in its greatest diameter, lesion in a location that in the opinion of the Investigator is difficult to maintain application of study drugs topically?\n2. Does the subject have a lesion due to leishmania that involves the mucosa or palate or any signs of mucosal disease that might be due to leishmania?\n3. Does the subject have signs and symptoms of disseminated disease in the opinion of the Principal Investigator?\n4. Does the subject have \\> 10 lesions?\n5. Is the subject a female who is breast-feeding?\n6. Does the subject have an active malignancy or history of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed?\n7. Does the subject have significant organ abnormality, chronic disease such as diabetes, severe hearing loss, evidence of renal or hepatic dysfunction, or creatinine, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) greater than 15% above the upper limit of normal (ULN) as defined by the clinical laboratory defined normal ranges?\n8. Has the subject received treatment for leishmaniasis including any medication with pentavalent antimony including sodium stibogluconate (Pentostam), meglumine antimoniate (Glucantime); amphotericin B (including liposomal amphotericin B and amphotericin B deoxycholate); or other medications containing paromomycin (administered parenterally or topically) or methylbenzethonium chloride (MBCL); gentamicin; fluconazole; ketoconazole; pentamidine; miltefosine, azithromycin or allopurinol that was completed within 8 weeks of starting study treatments?\n9. Does the subject have a history of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides?\n10. Does the subject have any other topical disease\u002Fcondition which would interfere with the objectives of this study?",false,"ALL","5 Years",{"count":61,"type":62},30,"ACTUAL","INTERVENTIONAL",[65],"PHASE2","The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in subjects with cutaneous leishmaniasis (CL).",[68],"Leishmaniasis, Cutaneous",[70,71,15,72,73,74,75,76],"leishmaniasis","cutaneous","paromomycin","gentamicin","pharmacokinetics","safety","efficacy","COMPLETED","2015-06-23",{"date":80,"type":81},"2015-07-16","ESTIMATED",{"date":83,"type":30},"2010-03",{"date":85,"type":62},"2011-07",{"name":5,"class":6},1]