[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cutaneous-leishmaniasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cutaneous-leishmaniasis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,46,100,124,142,173,192],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100573443","feasibility-of-integrating-thermotherapy-for-treatment-of-cutaneous-leishmaniasis-in-primary-health-care-setup-100573443",false,"NCT06746350","Feasibility of Integrating Thermotherapy for Treatment of Cutaneous Leishmaniasis in Primary Health Care Setup","Feasibility of Integrating Thermotherapy (TT) for Treatment of Cutaneous Leishmaniasis Into the Primary Healthcare Facilities in East Gurage Zone, Ethiopia","TTCL","Inclusion Criteria:\n\n* Males and females aged ≥12 and ≤60 years old.\n* Patient has a lesion that satisfies the following criteria:\n\n  * Lesion size \\\u003C or = 4 cm (longest diameter).\n  * Not located adjacent to ear, nose, eyes, lips, or close to mucosal membranes.\n  * Patient with \\\u003C or = 4 CL lesions\n* Patient able to give written informed consent.\n\nExclusion Criteria:\n\n* Any condition that prevents the patient from following the study treatment and\u002For the follow-up","ALL","12 Years","60 Years",{"count":21,"type":22},103,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study will look at how feasible it is to use thermotherapy (TT) as a treatment for skin(cutaneous) leishmaniasis (CL) in health centers in the Sodo and South Sodo districts, Ethiopia. The main questions the investigators want to answer are:\n\n* Is it practical, acceptable, and suitable to use thermotherapy for treating skin leishmaniasis in these health centers?\n* How effective is thermotherapy in treating skin leishmaniasis in this setting?\n\nHealth centers that do not offer thermotherapy will be used as a comparison group. Patients with CL in these areas will be monitored for up to 3 months before being sent to centers that provide thermotherapy.\n\nParticipants will be checked at a nearby health center to see if they meet the criteria for the study and then will be recruited. Patients with skin lesions will receive thermotherapy using the ThermoMed device, which heats the area to 50°C for 30 seconds. Their progress will be checked every 4 weeks until day 90. Depending on how well they respond, thermotherapy may be repeated at 4 or 8 weeks.",[28],"Cutaneous Leishmaniasis",[28,30,31,32],"Sodo","Thermotherapy","ThermoMed","RECRUITING","2026-06-09",{"date":36,"type":37},"2026-06-11","ACTUAL",{"date":39,"type":37},"2025-04-24",{"date":41,"type":22},"2027-05-25",{"name":43,"class":44},"Armauer Hansen Research Institute, Ethiopia","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":72,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100631921","early-detection-and-ai-based-management-of-skin-related-neglected-tropical-diseases-in-sub-saharan-africa-by-frontline-health-workers-100631921","NCT07506967","Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers","Early Detection and Management of SKIN-related negleCted Tropical Diseases Using Artificial Intelligence in Sub-saharan afRica (SkincAIr)","SkincAIr","1. Frontline Health Workers (FHWs) Age Group\n\n   * Age Range: 18 years and above o Justification: FHWs must be adults, legally eligible to provide healthcare services and consent to participate in the study Sex Distribution\n   * Male and Female FHWs o Justification: Both male and female FHWs will be included to reflect the actual workforce distribution and to ensure generalizability of the results across genders.\n\n   Inclusion criteria for FHWs:\n   1. Professional Role:\n\n      o Must be working as a FHW at one of the selected health centers at the time of the validation study.\n\n      ▪ Justification: The study aims to assess the diagnostic performance of those directly involved in primary patient care in the targeted settings.\n   2. Willingness to Participate:\n\n      o Willing to provide written informed consent to participate in the study.\n\n      ▪ Justification: Ethical standards require voluntary participation with informed consent.\n   3. Smartphone Usage:\n\n      o Willing and able to use a smartphone during the study.\n\n      ▪ Justification: The SkincAIr app is smartphone-based; therefore, FHWs must be willing to use and have access to such devices.\n   4. No Specialized Dermatology Training:\n\n      * FHWs without specialised training in dermatology or extensive experience in skin disease diagnosis.\n\n        * Justification: The study aims to evaluate the app's effectiveness among generalist healthcare workers who would benefit most from diagnostic support tools.\n\n   Exclusion criteria for FHWs:\n\n   1\\. Prior Specialised Training in dermatology:\n\n   o FHWs with formal education or extensive experience in dermatology.\n   * Justification: Including specialists could skew results, as their baseline diagnostic accuracy may already be high, reducing the observable impact of the app.\n\n     2\\. Refusal or Inability to Consent:\n     * FHWs unwilling or unable to provide written informed consent.\n   * Justification: Ethical compliance requires informed consent for participation. 3. Inability to Use the App: o FHWs unable to use a smartphone due to technical limitations, physical impairments, or lack of familiarity with the technology.\n   * Justification: Effective use of the app is essential for the intervention; inability to use it would prevent meaningful participation.\n2. Patients with Skin complaints Size\n\n   ● Total Patients: \\~750 patients Age Group\n\n   ● All Age Groups:\n\n   o Justification: Skin-NTDs affect individuals of all ages; including all age groups enhances the generalizability of the findings and assesses the app's effectiveness across the lifespan.\n\n   Sex Distribution\n   * Male and Female Patients\n   * Justification: Both sexes are included to capture the full spectrum of the disease burden and ensure the app's diagnostic accuracy is effective regardless of sex.\n\n   Inclusion Criteria for Patients with Skin complaints:\n\n   1\\. Presenting with Skin Complaints:\n\n   o Patients presenting to participating health centres with symptoms suggestive of skin-NTDs (e.g., visible skin lesions, nodules, ulcers) but have not been diagnosed by a specialist for that specific skin condition.\n   * Justification: The study aims to evaluate the app's effectiveness in real-world conditions, including all patients with potential skin-NTDs 2. Willingness to Participate: o Patients (or guardians, in the case of minors) willing to provide written informed consent for participation.\n   * Justification: Ethical standards require informed consent from patients or their legal guardians.\n\n     3\\. Ability to Comply with Study Procedures:\n\n     o Patients are able to follow study instructions and attend necessary follow-up appointments.\n   * Justification: Ensures complete data collection and accurate assessment of outcomes.\n\n     4\\. Patients with Co-morbid conditions:\n   * Justification: Immunosuppression that occurs in some comorbid conditions e.g. HIV\u002FAIDS or severe malnutrition can reveal the Skin disease and can affect both the clinical progression and even severity of the Skin NTD. This also includes patients with multiple skin-NTDs.\n\n   Exclusion Criteria for Patients with Skin complaints:\n   1. Refusal or Inability to Consent:\n\n      o Patients (or guardians) unwilling or unable to provide written informed consent.\n\n      ▪ Justification: Ethical compliance requires informed consent for participation.\n   2. Non-Skin-Related Complaints:\n\n      o Patients presenting with complaints unrelated to skin conditions.\n\n      ▪ Justification: The study focuses on skin-NTDs; including unrelated cases would not contribute to the study objectives.\n   3. Previous Participation in the Study:\n\n      o Patients who have already participated in the study.\n\n      ▪ Justification: To avoid duplicate data and potential bias in outcomes.\n\n      Additional Considerations:\n\n      Diversity and Representation ● Geographical Diversity:\n\n      o Including health centres from different regions within each country ensures that the findings are representative of various settings (urban, peri-urban, rural).\n\n      ● Cultural and Socioeconomic Factors:\n\n      o The study acknowledges that cultural beliefs and socioeconomic status may influence healthcare-seeking behaviour and disease presentation. By including a diverse patient population, the study aims to capture these variations.\n\n      Ethical Justification ● Inclusivity:\n      * Including all age groups and both sexes aligns with ethical principles of justice and fairness, ensuring that the benefits of the research are accessible to all segments of the population.\n\n        * Vulnerable Populations:\n      * While including minors and potentially vulnerable adults, the study will implement additional safeguards to protect their rights and well-being, following ethical guidelines and obtaining consent from guardians when necessary.","0 Years",{"count":56,"type":22},2420,[25],"Skin-related Neglected Tropical Diseases (Skin NTDs) affect about 1.8 billion people worldwide, particularly in poor and rural communities where healthcare access is limited. Many people rely on frontline health workers (FHWs) for treatment, but these workers often lack specialized training in skin diseases, making diagnosis difficult. To address this challenge, the SkincAIr project is testing whether a mobile app powered by artificial intelligence (AI) can help FHWs improve their ability to detect Skin NTDs. The study will be conducted in two arms. In the first clinical image data collection arm (36 months), dermatologists in 5 countries (Kenya, Ethiopia, Senegal, Democratic Republic of Congo and Nigeria) will collect images of skin NTD and other skin conditions that will be used for development and training of the AI model within the SkincAIr app before it is tested among FHWs. The second validation study arm will take place in 3 countries (Kenya, Ethiopia and Senegal), and will involve 50 FHWs and around 750 patients in each country over 24 months. During the first 12 months (Phase A), FHWs will diagnose patients using standard methods without the app, establishing baseline performance on key indicators including diagnostic accuracy, time to diagnosis, referral patterns, and cost implications of improved primary-level diagnosis. For the following 6 months (Phase B), FHWs will use the SkincAIr app with AI functionality activated to support diagnosis and enable real-time geolocated disease mapping and hotspot identification. In the final 6 months (Phase C), the app is withdrawn to assess whether FHWs retain their improved diagnostic skills. We will summarize the results using simple numbers and charts to show how often things happen and what the average results look like. Researchers will evaluate how well the app improves diagnosis by FHWs and whether FHWs retain their improved skills even after AI support is removed, by comparing their results with those of a skin specialist (dermatologist). Interviews and group discussions will be recorded, written down, organized into key ideas, and carefully reviewed using a computer program to understand the main themes. Study findings will be shared with National Ministries of Health, presented at local and international conferences, and reported to relevant institutional and regulatory authorities. If successful, this AI tool could boost early detection of skin diseases, enhance disease tracking, and improve healthcare in underserved areas.",[60,61,62,63,28,64,65,66,67,68,69,70,71],"Skin and Connective Tissue Diseases","Neglected Tropical Diseases","Leprosy","Buruli Ulcer","Scabies","Mycetoma","Lymphatic Filariasis","Onchocerciasis","Tungiasis","Post Kala-Azar Dermal Leishmaniasis","Yaws","Podoconiosis",[73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"Skin-related neglected tropical diseases","Artificial Intelligence","Mobile Health","mHealth","Frontline Health Workers","Diagnostic Accuracy","Sub-Saharan Africa","Skin NTDs","Digital Health","AI Diagnostic Tool","Capacity Building","Kenya","Ethiopia","Senegal","Nigeria","Democratic Republic of the Congo","NOT_YET_RECRUITING","2026-03-27",{"date":92,"type":37},"2026-04-02",{"date":94,"type":22},"2026-05-01",{"date":96,"type":22},"2030-05-31",{"name":98,"class":44},"Kenya Medical Research Institute",5,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":45},"100577380","phase-2-intralesional-injection-of-levofloxacin-for-the-management-of-cutaneous-leishmaniasis-100577380","NCT06797544","Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis","The Clinical Effect of Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis: Single Arm Open-label Trial","Inclusion Criteria:\n\n* Patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis and patients ranging in age from 20 to 75 years old.\n\nExclusion Criteria:\n\n* Patients who received anti-leishmaniasis treatment locally or systemically for the last month before this study and patients on prolonged corticosteroid therapy.","18 Years","80 Years",{"count":110,"type":22},40,[112],"PHASE2","Aim of the study to evaluate the effectiveness of intralesional levofloxacin 0.5% solution as a local injection in treating cutaneous leishmaniasis.\n\nIn an open-label single-arm clinical trial, all patients were given intralesional levofloxacin injections; the patients had cutaneous leishmaniasis lesions. Each lesion was considered a case in the final analysis. Each lesion will be followed up for 90 days (censor endpoint) or until the lesions are cured.\n\nIntralesional levofloxacin (5 mg\u002Fml, 100 ml, Tavanic®, Sanofi, France) will be injected into each lesion based on its size (5 mg\u002Fcm2). The infiltration of intralesional dose will be given once weekly for up to 6 weeks. Treatment will be stopped in patients cured before 6 weeks of treatment. A fine insulin needle will be used to infiltrate the lesion.",[28],"2025-09-29",{"date":117,"type":37},"2025-09-30",{"date":119,"type":37},"2025-02-09",{"date":121,"type":22},"2025-11-01",{"name":123,"class":44},"Hayder Adnan Fawzi",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":108,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":140,"locationsCount":45},"100577446","phase-2-ciprofloxacin-intralesional-injection-for-the-treatment-of-cutaneous-leishmaniasis-compared-to-sodium-stibogluconate-100577446","NCT06798402","Ciprofloxacin Intralesional Injection for the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate","Effectiveness of Ciprofloxacin Intralesional Injection in the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate: a Parallel Groups Comparative Trial","Inclusion Criteria:\n\n* Patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis\n\nExclusion Criteria:\n\n* Patients who received anti-leishmaniasis treatment locally or systemically for the last month before this study\n* patients on prolonged corticosteroid therapy.",{"count":132,"type":22},80,[112],"The Aim of the trial to evaluate the effectiveness of intralesional ciprofloxacin 0.2% solution as a local injection in treating cutaneous leishmaniasis and compare its effect with intralesional sodium stibogluconate (SSG) 10% intravenous solution in cutaneous leishmaniasis as a local injection.\n\nIn a randomized parallel groups clinical trial, patients were divided into two groups based on therapeutic regimen: 1) intralesional sodium stibogluconate weekly injection and 2) intralesional ciprofloxacin injection. Each lesion was considered a case in the final analysis. Each lesion will be followed up for 90 days (censor endpoint) or until the lesions are cured.",[28],{"date":117,"type":37},{"date":138,"type":37},"2025-02-07",{"date":121,"type":22},{"name":141,"class":44},"Al-Mustafa University College",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":155,"conditions":156,"keywords":159,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":45},"100604456","phase-1-pilot-study-miltefosine-gel-g-mtf-in-patients-with-cutaneous-leishmaniasis-100604456","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.","65 Years",{"count":152,"type":22},15,[154],"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",[28,157,158],"Cutaneous Leishmaniasis, American","Topical Administration",[160,161,162,163],"cutaneous leishmaniasis","topical treatment","miltefosine","hydrogel","2025-08-30",{"date":166,"type":37},"2025-09-08",{"date":168,"type":22},"2026-01-01",{"date":170,"type":22},"2026-08-30",{"name":172,"class":44},"Universidad Industrial de Santander",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":108,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":45},"100577447","phase-2-intralesional-injection-of-metronidazole-for-the-management-of-cutaneous-leishmaniasis-100577447","NCT06798415","Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis","The Clinical Effect of Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis: Single-arm Open-label Trial","Inclusion Criteria:\n\n* Patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis\n\nExclusion Criteria:\n\n* Immunocompromised\n* Allergic reaction to treatment.",{"count":110,"type":22},[112],"Aim of the study to evaluate the effectiveness of intralesional metronidazole 0.5% solution as a local injection in treating cutaneous leishmaniasis.\n\nIn an open-label single-arm clinical trial, all patients will be given intralesional levofloxacin injections; the patients had cutaneous leishmaniasis lesions. Each lesion will be considered a case in the final analysis. Each lesion will be followed up for 90 days (censor endpoint) or until the lesions are cured.\n\nIntralesional metronidazole (5 mg\u002Fml, 100 ml, Flagyl®, Sanofi, France) will be injected into each lesion based on its size (5 mg\u002Fcm2). The infiltration of intralesional dose will be given once weekly for up to 6 weeks. Treatment will be stopped in patients cured before 6 weeks of treatment, and patients will be only asked to come for lesion assessment. A fine insulin needle will be used to infiltrate the lesion.",[28],"2025-02-13",{"date":186,"type":37},"2025-02-14",{"date":188,"type":37},"2025-02-10",{"date":190,"type":22},"2025-05-01",{"name":123,"class":44},{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":200,"maxAge":108,"enrollmentInfo":4,"targetDuration":4,"studyType":201,"phases":4,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":204,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":208,"locationsCount":4},"100154098","pilot-study-using-a-heat-pack-to-treat-cutaneous-leishmaniasis-100154098","NCT01277796","Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis","Pilot Study of Thermotherapy Treatment for Cutaneous Leishmaniasis in Peru With the HECT-CL Device","HECT","Inclusion Criteria:\n\n* with CL diagnosed by skin smear (WHO method), biopsy, culture, PCR\n* aged 8-80 years old\n* with no more than 3 lesions\n* ulcerative and non-ulcerative ulcers less than 4 cm diameter.\n* allergy, prohibitive side effects to standard chemotherapy, or other contraindication to antimonial treatment (e.g. cardiac arrhythmia)\n* capable of signing an informed consent or having capable guardians (in the case of minors).\n* Children ≥ 8 years of age must give written or verbal informed assent along with written consent of their guardians.\n\nExclusion Criteria:\n\n* lesions less than 2cm from the nose, mouth, ears, or eyes.\n* clinically diagnosed with mucosal involvement.\n* evidence of lymph node involvement on exam.\n* unable or unwilling to commit to the treatment and follow-up plan.\n* prior CL treatment within last 1 month.\n* pregnant or lactating\n* uncontrolled severe systemic illness or immunocompromised state.","8 Years","EXPANDED_ACCESS","Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are expensive, toxic\u002Fallergenic, frequently ineffective, burdensome, and often unavailable. Thermotherapy is a clinically validated first line alternative for the treatment of Cutaneous Leishmaniasis in South America. However, current heat-delivery modalities are either too costly or lack governmental approval required to be made widely available to endemic areas. The investigators have adapted a reliable, safe, and low-cost heat pack for Cutaneous Leishmaniasis that the investigators have named the HECT-CL device. In this pilot study the investigators will enroll 25 patients who have either failed or are not candidates for pentivalent antimonies. The hypothesis states that the HECT-CL device demonstrates efficacy non-statistically inferior to estimates for current South American Pentavalent Antimonial cure rates (76%) while demonstrating basic safety and tolerability.",[28],"AVAILABLE","2011-01-14",{"date":207,"type":22},"2011-01-17",{"name":209,"class":44},"Universidad Peruana Cayetano Heredia"]