[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leishmaniasis-cutaneous\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leishmaniasis-cutaneous":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100579298","phase-3-arnica-tincture-fot-the-treatment-of-cutaneous-leishmaniasis-ii-100579298",false,"NCT06822478","Arnica Tincture Fot the Treatment of Cutaneous Leishmaniasis II.","Randomized Blinded Clinical Trial to Evaluate the Safety and Efficacy of Arnica Tincture in the Topical Treatment of Cutaneous Leishmaniasis.","ARNICA","Inclusion Criteria:\n\nParticipants who meet the following inclusion criteria may enter the study and receive arnica tincture or intralesional pentavalent antimonials:\n\n1\\. Males or females, over 12 years of age and adults without age limit. With a confirmed parasitological diagnosis of a primary infection of LC in at least one lesion, made by one of the following methods: 1) microscopic identification of amastigotes in the lesion tissue; 2) diagnosis of leishmania by PCR; 3) positive culture for promastigotes (Annex 2).\n\n3\\. With clinical diagnosis of localized LC. 4. Ulcer, nodule or plaque type lesions. Up to 9 lesions in total, and that the total area of all lesions is ≤1875 mm2 6. Subjects who have given written IC\u002FAssent. 7. Subject is able to understand and comply with the requirements of the study. 8. Subjects who are able to attend the control visits.\n\nExclusion Criteria:\n\nParticipants presenting one or more of the following criteria should be excluded from the study:\n\n1. Diagnosis or suspicion of mucosal\u002Fmucocutaneous, diffuse or disseminated Leishmaniasis or relapse or reactivation of an LC.\n2. Subjects with lesions involving the auricular region, orbital region, nasal region and\u002For labial region of the face, joints or in places that, in the opinion of the investigator, are difficult to apply topically or intralesionally to the study medication.\n3. History of clinically significant cardiovascular, renal, hepatic, hepatic, neurological or immunological diseases that may interact positively or negatively with the treatment.\n4. Having received treatment for Leishmaniasis or other treatment that, in the judgment of the investigator, may modify the course of infection with Leishmania in the last 8 weeks (56 days) prior to admission.\n5. Women with a positive pregnancy test during the screening process, or lactating, or women of childbearing age who do not agree to the use of contraceptives during treatment and until DPT45.\n6. Known or suspected history of hypersensitivity or idiosyncratic reactions to the investigational product or pentavalent antimonials in the trial.\n7. Subjects who are unwilling to attend study visits or who are unable to comply with follow-up visits for up to three months.","ALL","12 Years",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Cutaneous leishmaniasis (CL) is a parasitic disease caused by more than 20 different species of the protozoan parasite Leishmania. CL usually begins with a papule at the site of the sandfly bite, which enlarges to form a nodule that progresses to an ulceration, or a scaly or warty plaque, over a period of 1 to 3 months.\n\nThe exact incidence of CL is not known. An estimated 1.2 million cases\u002Fyear in approximately 100 countries worldwide suffer from different forms of CL. More than 90% of CL cases occur in the Americas and Eastern Mediterranean regions. Afghanistan, Algeria, Brazil, Colombia, Iraq, Pakistan, and Syria report more than 80% of new CL cases worldwide. Since 2010, the World Health Organization has insisted on the need to work on products that become alternatives for the treatment of LC, especially in products that can be applied topically because with them the probability of systemic toxicity is lower, increasing patient safety.\n\nCurrently, it is recommended to apply local treatments for patients with localized LC, either with pentavalent antimonials administered intralesionally or with thermotherapy. Among the options for topical treatment are natural products that have been, are and will be of utmost importance as sources of medicinal agents. In addition to natural products that have found direct medicinal applications as pharmaceutical entities, many others can serve as chemical models or templates for the design, synthesis and semi-synthesis of novel substances for the treatment of human diseases.\n\nArnica montana L. is a plant with anti-emollient, healing, anti-inflammatory, analgesic and antineuralgic properties; it is included in the Colombian vademecum of medicinal plants.\n\nIn a randomized phase Ib\u002FII clinical trial conducted in patients with localized LC in Colombia, 100% (per protocol analysis) and 92% (intention-to-treat analysis) efficacy was demonstrated, with no adverse effects other than those expected such as erythema, burning, pain or itching.\n\nBy demonstrating that arnica tincture is effective and safe, and that A. montana flower extracts in different preparations (topical solutions, tinctures, liniments, ointments or gels) are approved by the European Medicines Agency and are included in the vademecum of Colombian plants issued by the Ministry of Social Protection of Colombia in 2008, the present study aims to establish the safety and efficacy of arnica tincture as an alternative for the topical treatment of localized LC compared to a currently available local therapeutic alternative: intralesional pentavalent antimonials.",[27],"Leishmaniasis, Cutaneous",[29,30,31],"Leishmaniasis","Cutáneo","Tintura de árnica","RECRUITING","2026-03-27",{"date":35,"type":36},"2026-04-02","ACTUAL",{"date":38,"type":36},"2026-03-11",{"date":40,"type":21},"2030-02",{"name":42,"class":43},"Universidad de Antioquia","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":44},"100631751","leish-ped-study-on-leishmaniasis-in-children-100631751","NCT07504757","LEISH-PED: Study on Leishmaniasis in Children","A Multicenter Study on Leishmaniasis in Children: Clinical and Epidemiological Characteristics and Outcomes","LEISH-PED","Inclusion Criteria:\n\n* Patients younger than 18 years of age at the time of diagnosis\n* Diagnosis of human leishmaniasis according to World Health Organization (WHO) criteria\n* Written informed consent signed by parents or legal guardians; patient assent when applicable\n\nExclusion Criteria:\n\n* Patients who do not meet the diagnostic criteria for confirmed human leishmaniasis\n* Lack of informed consent signed by parents or legal guardians, when required","17 Years",{"count":55,"type":21},200,"OBSERVATIONAL","Leishmaniasis is an infection caused by Leishmania parasites. In children, it can affect the skin or internal organs. Diagnosis may be delayed because the signs and symptoms can be similar to those of other conditions. Delayed diagnosis or treatment may lead to worse outcomes. Treatment approaches, especially for cutaneous leishmaniasis, may also vary across centers. This study aims to improve knowledge about pediatric leishmaniasis in Italy.\n\nThis is a multicenter observational study in children younger than 18 years of age with a diagnosis of human leishmaniasis according to World Health Organization criteria. The study includes both retrospective and prospective data from participating centers in Italy. Researchers will collect and analyze clinical, diagnostic, epidemiological, treatment, and outcome data from the baseline visit and from follow-up during the first year.\n\nThe main goal of the study is to describe the clinical and epidemiological features of pediatric leishmaniasis in Italy over the study period, with a particular focus on diagnostic and treatment delay and on patient outcomes. The study will also assess the frequency and severity of disease over time and compare outcomes associated with different treatment approaches, particularly in cutaneous leishmaniasis. Patients evaluated between January 1, 2013 and June 30, 2031 may be included.",[59,60,27,61],"Leishmania Infantum Disease","Leishmaniasis, Visceral","Leishmaniasis, Mucocutaneous",[63,64,65,66,67,68,69,70],"Pediatric leishmaniasis","Visceral leishmaniasis","Cutaneous leishmaniasis","Mucocutaneous leishmaniasis","Children","Italy","Diagnostic delay","Leishmania infantum","2026-03-26",{"date":73,"type":36},"2026-04-01",{"date":75,"type":36},"2025-01-30",{"date":77,"type":21},"2031-12-30",{"name":79,"class":43},"Meyer Children's Hospital IRCCS",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100569507","phase-3-antimicrobial-adjuvants-to-revert-the-imbalance-of-skin-microbiota-for-improved-outcomes-of-complicated-cutaneous-leishmaniasis-treatment-in-ethiopia-100569507","NCT06695143","Antimicrobial Adjuvants to Revert the Imbalance of Skin Microbiota for Improved Outcomes of Complicated Cutaneous Leishmaniasis Treatment in Ethiopia","AIM-CL","Clinically suspected complicated CL patients visiting the study site meeting the following inclusion criteria and none of the exclusion criteria:\n\nInclusion:\n\n* Clinical diagnosis of CL\n* Need for systemic treatment (1 or more of these criteria)\n\n  * Mucosal involvement of lesion or at risk for mucosal involvement (\\\u003C 1 cm from the nose, eyes and vermillion border of the lips)\n  * Lesion size \\>4 cm\n  * \\>4 lesions\n  * Lesions on joints or fingers\n  * Lesions previously not responding to local treatment\n  * Lesions unsuitable for local treatment (e.g., eyelids)\n  * Lesions with signs of dissemination (satellite lesions, nodular lymphangitis, sporotrichoid pattern)\n* Age \\> 4 (minimum age to receive systemic treatment with SSG)\n* At least one lesion eligible for treatment\\* (meeting all criteria below)\n\n  * lesion with surface change, including ulcerated, crusted and scaly lesions\n  * distinguishable from other lesions (minimum 0.5 cm apart)\n  * no mucosal involvement against which a topical agent would likely not be effective (e.g., lesions that are located too deep within the nasal passages or on the inner lip, where proper application is challenging and the ointment may be easily removed or not adequately absorbed)\n* Willing and able to provide informed consent. For participants under the age of 18, parental or caregiver consent is required. Additionally, assent must be obtained from adolescents aged 12 to 17\n* Willing to be hospitalized for 4 weeks\n\nExclusion:\n\n* DCL patients\n* Only lesions not eligible for treatment\\*\n* Currently on treatment or having received non-traditional antileishmanial treatment (cryotherapy, thermotherapy, sodium stibogluconate, meglumine antimoniate, paromomycin, pentamidine, AmBisome, miltefosine, non-liposomal amphotericin B) in the past 1 month\n* Currently on or having received topical antibiotic treatment for CL lesion(s) in the past 1 month\n* Currently on or having received systemic antibiotic treatment in general in the past 1 month\n* Currently in need for systemic antibiotics\n* Pregnant (positive pregnancy test at D0) or breastfeeding\n* Abnormal lab values\n\n  * Hemoglobin \\\u003C 5.0g\u002F100mL\n  * Platelets \\\u003C 50 x 10\\^9\u002FL\n  * White blood count \\\u003C 1 x 10\\^9\u002FL\n  * ASAT\u002FALAT \\> 3x upper normal range\n  * Creatinine above the normal limit\n* Prolonged QTc interval or arrythmia on ECG or history of arrythmias\n* Known serious kidney or liver disease\n* Known allergies to one of the study components\u002Fmedications\n* Serious adverse reaction to a previous SSG dose \\*If a patient has multiple lesions, of which some are eligible for treatment and others are not, the patient can still be involved in the study. Only the eligible lesions will be subjected to treatment and outcome assessment.","4 Years",{"count":89,"type":21},180,[24],"This clinical trial aims to evaluate the effectiveness of combining the standard treatment for complicated cutaneous leishmaniasis (CL), sodium stibogluconate (SSG), with either topical fusidic acid 2% cream or a vehicle cream without active ingredient. The goal is to assess whether this combination improves treatment outcomes by restoring the balance of the skin microbiome (dysbiosis) in patients with severe CL, a condition common in Ethiopia.\n\nThe study will compare three treatment groups:\n\n* Fusidic Acid Group: SSG plus topical fusidic acid for 2 weeks.\n* Vehicle Cream Group: SSG plus topical vehicle cream for 2 weeks.\n* Control Group: SSG only, with no topical treatment.\n\nThe primary objective is to determine if the addition of fusidic acid improves treatment outcomes compared to SSG alone, as measured by substantial improvement in the index lesion at the end of treatment (EoT).\n\nA total of 180 patients will be enrolled at two hospitals in Ethiopia. The trial will run for 24 months, with a focus on understanding how restoring the skin microbiome can improve CL treatment outcomes and potentially provide a low-cost, accessible treatment strategy for CL patients.",[27],[94,95],"Cutaneous Leishmania","Complicated cutaneous leishmania","NOT_YET_RECRUITING","2024-11-16",{"date":99,"type":36},"2024-11-19",{"date":101,"type":21},"2025-04",{"date":103,"type":21},"2027-04",{"name":105,"class":43},"Institute of Tropical Medicine, Belgium",2]