[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604456":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":34,"locations":46,"responsibleParty":62,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":39,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":96,"whyStopped":39,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Universidad Industrial de Santander","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"MILTEFOSINE hydrogel 0.5%","EXPERIMENTAL","MILTEFOSINE hydrogel 0.5% topically daily for 28 days",[13],"Drug: MILTEFOSINE gel",{"label":15,"type":10,"description":16,"interventionNames":17},"MILTEFOSINE hydrogel 1.0%","MILTEFOSINE hydrogel 1.0% topically daily for 28 days",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"MILTEFOSINE hydrogel 1.5%","MILTEFOSINE hydrogel 1.5% topically daily for 28 days",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","MILTEFOSINE gel","Each patient will receive a 30 g tube of G-MTF with instructions and recommendations for use. The first dose will be in the FOSCAL clinical studies unit; subsequent doses will be applied at the patient's site of origin based on their autonomy, once a day (morning or night). Instructions include washing hands thoroughly, cleaning the lesion, applying a thin layer of gel, leaving it uncovered for at least 15 minutes, avoiding contact with water until the next dose, and storing the gel properly during treatment.",[9,15,19],[29],"topical miltefosine",[31],{"name":32,"affiliation":5,"role":33},"Cristian Blanco, PhD","STUDY_CHAIR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Patricia Escobar, PhD","CONTACT","+573123160985",null,"pescobar@uis.edu.co",{"name":42,"role":37,"phone":43,"phoneExt":44,"email":45},"JAIME A GOMEZ, MD, IM","57 607 7000 300","6162","jgomez608@unab.edu.co",[47],{"facility":48,"status":39,"city":49,"state":50,"zip":39,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Calle 158 No. 20-95 Cañaveral","Floridablanca","Santander Department","Colombia","CO",{"type":54,"coordinates":55},"Point",[56,57],-73.08644,7.06222,{"lat":57,"lon":56},[60],{"name":36,"role":37,"phone":61,"phoneExt":39,"email":40},"57 3123160985",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"PRINCIPAL_INVESTIGATOR","Patricia Escobar","Professor, PhD",[67],{"name":68,"class":6},"Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle","100604456","phase-1-pilot-study-miltefosine-gel-g-mtf-in-patients-with-cutaneous-leishmaniasis-100604456",false,"NCT07149753","Pilot Study: Miltefosine Gel (G-MTF) in Patients With Cutaneous Leishmaniasis","Pilot Study: Safety and Therapeutic Dose of a Miltefosine Gel (G-MTF) in Patients With Uncomplicated Cutaneous Leishmaniasis (NCCL)","G-MTF01","Inclusion Criteria:\n\n* Diagnosis of confirmed cutaneous leishmaniasis (CL)\n* Age: 18 - 65 years.\n* Patients who have 1-4 CL skin lesions with a diameter of 1-4 cm, with an evolution time of more than one month and not located on the face, ears, or joints.\n* Patients WITHOUT suspected complicated CL (large regional lymphadenopathy, several large lesions spread to different parts of the body); NO mucosal leishmaniasis and NO suspicion of unusual leishmaniasis syndromes (e.g., recurrent leishmaniasis, diffuse or disseminated CL).\n* Patients with NO history of systemic antileishmania treatment within 8 weeks prior to starting the study.\n* Patients WITHOUT treatment failure with local therapy (intralesional antimonial injections or thermotherapy) or systemic therapy.\n\nExclusion Criteria:\n\n* Pregnant or lactating women; women of reproductive age who refuse to use contraception until 45 days after treatment ends.\n* Patients with cardiovascular, hepatic, or renal impairment or who report underlying diseases that medically compromise their participation in this study.\n* Patients who report a history of immunodeficiency.","ALL","18 Years","65 Years",{"count":81,"type":82},15,"ESTIMATED","INTERVENTIONAL",[85],"PHASE1","The goal of this clinical trial is to learn if the drug MILTEFOSINE, used topically in a hydrogel, works to treat non-complicated cutaneous leishmaniasis (CL) in adults. It will also learn about the safety of the drug MILTEFOSINE used topically. The main questions it aims to answer are:\n\n* Is topical treatment with MILTEFOSINE hydrogel effective in patients with CL, thus justifying its continuation in the clinical phases (II and III) of development?\n* What skin problems do participants have when using miltefosine hydrogels over CL lesions? Researchers will evaluate the safety and effectiveness of various concentrations of MILTEFOSINE hydrogel: 0.5%, 1.0%, and 1.5%.\n\nParticipants will:\n\n* Apply the MILTEFOSINE hydrogel to the affected lesions daily for 28 consecutive days.\n* Visit the Center at least two days prior to the study. This initial visit will include diagnostic tests, interviews, study information, informed consent, and the administration of the first doses. After this, patients are required to return to the clinic on day 28 and again three months later for additional check-ups and tests.\n* Take a photo once a week for checkups, and keep a note of their symptoms",[88,89,90],"Cutaneous Leishmaniasis","Cutaneous Leishmaniasis, American","Topical Administration",[92,93,94,95],"cutaneous leishmaniasis","topical treatment","miltefosine","hydrogel","NOT_YET_RECRUITING","2025-08-30",{"date":99,"type":100},"2025-09-08","ACTUAL",{"date":102,"type":82},"2026-01-01",{"date":104,"type":82},"2026-08-30",{"name":5,"class":6},1]