[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"old-world-cutaneous-leishmaniasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:old-world-cutaneous-leishmaniasis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100383122","phase-3-randomised-clinical-trial-for-new-treatment-modalities-for-cutaneous-leishmaniasis-caused-by-leishmania-tropica-in-pakistan-100383122",false,"NCT04268524","Randomised Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan","Randomised, Open Label, Multicentre, Non-inferiority Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan","Inclusion Criteria:\n\n* Male and female patients with clinical and laboratory confirmed CL, and who can be treated with localised intralesional antimonial injections and\u002For thermotherapy:\n* lesion size ≥0.5 cm and ≤4 cm\n* not located on the ear, nose, near to the eye or mucosal membranes, on joints, or on a location that in the opinion of the principle investigator (PI) is difficult to apply thermotherapy (TT) or intralesional (IL) injections\n* patient with ≤4 lesions\n* duration of lesions less than five months by patient history\n* Patients who have signed the informed consent form.\n\nExclusion Criteria:\n\n* Pregnant women and breast feeding women\n* Non-pregnant women in reproductive age refusing effective (injectable) contraception for a period of five months\n* Patients \\\u003C10years old\n* Patients who cannot be treated with localised IL antimonial injections or TT (patients with more than 4 lesions, lesions \\>4cm in diameter, or located on joints, lips, nose, ears or near eyes)\n* History of clinically significant medical problems or treatment that might interact with the study treatment and interact with wound healing, such as diabetes, vascular diseases and any immunocompromising condition\n* Within eight weeks of trial D1 received treatment for leishmaniasis with any medication\n* History of known or suspected hypersensitivity of idiosyncratic reactions to trial medication or excipients\n* Has laboratory values at screening: serum creatinine above normal level; ALT 3 times above normal range\n* Patient who is not willing to attend the trial visits, or is not able to comply with follow-up visits up to three months.\n* Known history of drug addiction and\u002For alcohol abuse","ALL","10 Years",{"count":19,"type":20},832,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","randomised control clinical trial to evaluate miltefosine, thermotherapy and the combination miltefosine-thermotherapy are effective, safe and tolerable alternative treatment options to treat cutaneous leishmaniasis caused by L. tropica, in Pakistan compared to the standard of care.",[26],"Old World Cutaneous Leishmaniasis",[28,29],"miltefosine","Thermotherapy","RECRUITING","2025-05-06",{"date":33,"type":34},"2025-05-09","ACTUAL",{"date":36,"type":34},"2022-10-07",{"date":38,"type":20},"2026-01-31",{"name":40,"class":41},"Medecins Sans Frontieres, Netherlands","OTHER",2]