[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100383122":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":75,"collaborators":26,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":26,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":26,"enrollmentInfo":86,"targetDuration":26,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":51,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Medecins Sans Frontieres, Netherlands","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"monotherapy miltefosine","EXPERIMENTAL","Miltefosine capsules (Impavido®) 2.5 mg\u002Fkg daily PO for 28 days \\\u003C30 kg BW allometric miltefosine dose based on fat-free mass. (approx. 2.5 mg\u002Fkg); \\>30 - ≤44kg BW: 100 mg\u002Fday BID; ≥45kg BW 150mg TDS",[13],"Combination Product: drug: miltefosine with thermotherapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Thermotherapy","Thermotherapy (ThermoMed 1.8 ®) 50°C for 30 seconds, 1 session",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Combination miltefosine and thermotherapy","Miltefosine capsules 2.5 mg\u002Fkg daily PO for 21days, and thermotherapy 50°C for 30 seconds, one session on day 1 of the miltefosine.",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"° Meglumine antimoniate (Glucantime®) intralesional","ACTIVE_COMPARATOR","Meglumine antimoniate (Glucantime®) intralesional injections 0.5-3ml, 8 sessions, bi-weekly",null,[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"COMBINATION_PRODUCT","drug: miltefosine with thermotherapy","see previous",[19,15,9],[34],"device ThermoMed 1.8",[36],{"name":37,"affiliation":5,"role":38},"Koert Ritmeijer","STUDY_DIRECTOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Suzette Sabine Kämink","CONTACT","+31643690015","s.s.kamink@gmail.com",{"name":37,"role":42,"phone":46,"phoneExt":26,"email":47},"+31 6 24453143","koert.ritmeijer@oca.msf.org",[49,65],{"facility":50,"status":51,"city":52,"state":53,"zip":26,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Kuchlak Primary Health Care Centre (MCH)","RECRUITING","Kuchlagh","Balochistan","Pakistan","PK",{"type":57,"coordinates":58},"Point",[59,60],66.94017,30.35218,{"lat":60,"lon":59},[63],{"name":64,"role":42,"phone":43,"phoneExt":26,"email":44},"Suzette Sabine Kamink",{"facility":66,"status":51,"city":67,"state":53,"zip":26,"country":54,"countryCode":55,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Shaheed Mohtarma Benazir Bhutto General Hospital","Quetta",{"type":57,"coordinates":69},[70,71],67.00141,30.18414,{"lat":71,"lon":70},[74],{"name":64,"role":42,"phone":43,"phoneExt":26,"email":44},{"type":76,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":87,"type":88},832,"ESTIMATED","INTERVENTIONAL",[91],"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.",[94],"Old World Cutaneous Leishmaniasis",[96,15],"miltefosine","2025-05-06",{"date":99,"type":100},"2025-05-09","ACTUAL",{"date":102,"type":100},"2022-10-07",{"date":104,"type":88},"2026-01-31",{"name":5,"class":6},2]