[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leprosy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leprosy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,42,70,104,157,185,209,234,262,285,306],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100485146","phase-3-bedaquiline-enhanced-post-exposure-prophylaxis-for-leprosy-100485146",false,"NCT05597280","Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy","Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 3 Study","BE-PEOPLE P3","Inclusion Criteria:\n\n1. Living in one of the study clusters (34 on Anjouan, 10 on Mohéli), in good state of health\n2. Aged 2 years and above, as leprosy is very rare among infants and young toddlers. Children age 2-4 years or weighing less than 20 kg will not be given bedaquiline. If eligible they will receive only rifampicin.\n3. Able and willing to provide informed consent for leprosy and tuberculosis screening, and PEP administration (as applicable in the different arms)\n\nExclusion Criteria:\n\n1. Signs of active leprosy\n2. Signs of active pulmonary tuberculosis (cough ≥2 weeks duration and without a negative TB test)\n3. Signs of active extra-pulmonary tuberculosis (bluish-red nodules that cover the lymph nodes, bones or joints, or cervical glands with discharge)\n4. Having received rifampicin or bedaquiline (if applicable) in the last 2-year period\n5. Self-reported (suspected) pregnancy or breastfeeding\n6. Concurrent (within the last three week period before D0) use of medications not included in the safe list (for bedaquiline only)",true,"ALL","2 Years",{"count":21,"type":22},124000,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","There will be two study arms. Arm 1 will be the intervention arm in which there will be provided BE-PEP to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts. Arm 2 will be the comparator arm in which the WHO recommended standard PEP will be provided, i.e. 10 mg\u002Fkg of rifampicin in a single dose. In both arms the investigators will target anyone living within 100 meters of an index case or the entire village if more than 50% are eligible. Provision of BE-PEP will start in 2023 and follow-up will continue until 2026. The main study outcome will be the comparison of leprosy risk in individuals that received BE-PEOPLE standard WHO SDR-PEP versus individuals that received BE-PEP. In addition the investigators will compare the overall leprosy incidence over the follow-up period between the two study arms.",[28],"Leprosy","RECRUITING","2026-05-18",{"date":32,"type":33},"2026-05-19","ACTUAL",{"date":35,"type":33},"2023-03-22",{"date":37,"type":22},"2027-03-15",{"name":39,"class":40},"Institute of Tropical Medicine, Belgium","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":41},"100574606","leprosy-active-searching-trial-in-brazil-100574606","NCT06761469","Leprosy Active Searching Trial in Brazil","Pragmatic, Randomized, Cluster Stepped-Wedge Clinical Trial for Active Case Finding of Leprosy in Brazil","LAST•Br","Inclusion Criteria:\n\n(I) Municipalities\n\n* Municipality recognized by the Brazilian Institute of Geography and Statistics as part of the Brazilian Federation.\n* Municipality with operational epidemiological classification by the Ministry of Health (BMoH) as: 'municipalities with cases in the period from 2015 to 2019'.\n* Municipality with authorization\u002Fconsent from the government to participate in the study.\n\n(II) Primary Health Units (Unidade Básica de Saúde or UBS) • UBS with territorial coverage (linked population) within the participating municipality.\n\n(III) Participants\n\n• Patients with positive Leprosy Suspicion Questionnaire (LSQ): children under five years old with Free and Informed Consent Form (ICF) signed by parents\u002Fguardians, 5-17 years old with ICF signed by parents\u002Fguardians and Free and Informed Assent Form (IAF) signed by the minor, and patients over 18 years old with ICF signed for: rapid test collection, comorbidity questionnaire and clinical evaluation; and if leprosy diagnosis is confirmed, collection of complementary exams.\n\nExclusion Criteria:\n\n(I) Municipalities\n\n* Municipality with extreme population size (municipalities with a number of inhabitants lower than the 10th percentile and higher than the 90th percentile).\n* Municipality with operational epidemiological classification by the BMoH as: 'municipalities without cases in the period 2015 to 2019'.\n* Municipalities with active or recent participation (less than one year) in other active-finding strategies, in addition to the usual ones: ministerial, Non-Governmental Organizations (NGOs), academic, among others.\n\n(II) Primary Health Units\n\n* UBS with limited multidisciplinary team (absence of physicians, nurse and\u002For community health agents).\n* UBS with difficult access (no access by land, i.e. riverside populations).\n* UBS with territorial coverage exclusively of indigenous populations.\n\n(III) Participants\n\n* LSQ negative.\n* Patients with a previous diagnosis or history of treated leprosy.\n* Patients residing\u002Fregistered outside the selected municipality.",{"count":51,"type":22},1925,[53],"NA","The goal of this clinical trial is to assess whether a multifactorial active case-finding strategy improves the detection of leprosy cases in Brazil compared to usual screening practices. The main questions it aims to answer are:\n\n\\- Does the intervention increase the number of new leprosy cases detected compared to standard care?\n\nParticipants will:\n\n* Receive community awareness about leprosy.\n* Be screened using the Leprosy Suspicion Questionnaire at priority areas identified by georeference tools.\n* Undergo clinical evaluation by a trained medical team.\n* If leprosy is diagnosed, affected patients will collect complementary laboratory exams\n\nHealthcare professionals from primary care units will receive training in leprosy, while researchers will monitor changes in leprosy incidence over a 12-month period using data from Brazil's national notification system. The study will provide insights into underdiagnosis and the clinical profiles of patients who have been diagnosed.",[28],[28,57,58,59,60],"Active-case finding","Cluster stepped-wedge","Clinical trial","Brazil","2026-04-26",{"date":63,"type":33},"2026-04-28",{"date":65,"type":33},"2025-06-01",{"date":67,"type":22},"2026-05-31",{"name":69,"class":40},"Hospital Alemão Oswaldo Cruz",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":18,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":81,"conditions":82,"keywords":88,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":41},"100632615","accuracy-of-the-polymerase-chain-reaction-of-ulnar-perineural-subcutaneous-aspirate-guided-by-ultrasound-for-the-diagnosis-and-monitoring-of-leprosy-cure-100632615","NCT07515989","Accuracy of the Polymerase Chain Reaction of Ulnar Perineural Subcutaneous Aspirate Guided by Ultrasound for the Diagnosis and Monitoring of Leprosy Cure","Does not exist","Inclusion Criteria:\n\nIndividuals aged 14 years or older;\n\nClinical suspicion of leprosy based on dermatologic or neurologic examination OR;\n\nPresence of peripheral nerve enlargement or skin lesions compatible with leprosy;\n\nAbility to provide written informed consent.\n\n\\-\n\nExclusion Criteria:\n\nPrevious treatment for leprosy;\n\nContraindication to the aspiration procedure (e.g., coagulopathy or anticoagulant therapy);\n\nLocal infection at the puncture site;\n\nInability or unwillingness to provide informed consent.","14 Years",{"count":79,"type":22},108,[53],"\\*\\*Brief Summary\\*\\*\n\nLeprosy is a chronic granulomatous infectious disease caused by \\*Mycobacterium leprae\\* or \\*Mycobacterium lepromatosis\\*, characterized by peripheral nerve involvement that may lead to progressive neurological damage, disability, and deformities if not diagnosed and treated early. The diagnosis of leprosy is primarily clinical and epidemiological, supported by laboratory methods such as bacilloscopy and biopsy; however, these tests have limited sensitivity, particularly due to the bacillus' tropism for peripheral nerve structures.\n\nUltrasonography has emerged as a non-invasive imaging method capable of detecting morphological changes in peripheral nerves, including nerve enlargement, fascicular abnormalities, and inflammatory hypervascularization. Despite its diagnostic value, ultrasonography alone cannot detect the presence of the bacillus.\n\nThis prospective cohort study aims to evaluate the diagnostic and prognostic accuracy of combining clinical evaluation, peripheral nerve ultrasonography, and molecular detection techniques using subcutaneous perineural aspirate. Patients with suspected leprosy attending the Leprosy Outpatient Clinic at the University Hospital of Brasília will undergo clinical evaluation, ultrasound examination of the ulnar nerves, and ultrasound-guided subcutaneous perineural aspirate for molecular detection of \\*Mycobacterium leprae\\* DNA and RNA using real-time PCR and RT-PCR.\n\nParticipants will be followed for one year, with assessments performed at diagnosis and after one year of treatment. The study will compare clinical, imaging, and molecular findings to determine whether perineural subcutaneous aspirate combined with ultrasonography improves early detection and diagnostic accuracy compared with conventional methods such as bacilloscopy and biopsy.\n\nThe study aims to contribute to improved diagnostic strategies for leprosy, enabling earlier detection of neural involvement and potentially reducing disease transmission and long-term disability.",[28,83,84,85,86,87],"Leprosy Neuropathy","Leprosy, Multibacillary","Leprosy--Patients","Mononeuropathies","Polyneuropathies",[28,89,90,91,92,93,94],"Slit Skin smear","Polimerase chain reaction","RLEP","16S","Sod","Periferal Nerve Ultrassound","2026-04-02",{"date":97,"type":33},"2026-04-07",{"date":99,"type":33},"2026-01-01",{"date":101,"type":22},"2027-08-31",{"name":103,"class":40},"University of Brasilia",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":18,"minAge":112,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":130,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"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":114,"type":22},2420,[53],"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.",[118,119,28,120,121,122,123,124,125,126,127,128,129],"Skin and Connective Tissue Diseases","Neglected Tropical Diseases","Buruli Ulcer","Cutaneous Leishmaniasis","Scabies","Mycetoma","Lymphatic Filariasis","Onchocerciasis","Tungiasis","Post Kala-Azar Dermal Leishmaniasis","Yaws","Podoconiosis",[131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146],"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":95,"type":33},{"date":151,"type":22},"2026-05-01",{"date":153,"type":22},"2030-05-31",{"name":155,"class":40},"Kenya Medical Research Institute",5,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":166,"phases":4,"briefSummary":167,"conditions":168,"keywords":171,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":41},"100627419","epidemiological-clinical-diagnostic-and-therapeutic-characteristics-of-hansens-disease-in-costa-rica-2018-2025-100627419","NCT07448389","Epidemiological, Clinical, Diagnostic, and Therapeutic Characteristics of Hansen's Disease in Costa Rica (2018-2025)","Retrospective Observational Study for the Epidemiological, Clinical, Diagnostic, and Therapeutic Characterization of Hansen's Disease With Confirmed Diagnosis in Costa Rica During 2018-2025","Inclusion Criteria:\n\n* Confirmed diagnosis of Hansen's disease.\n* Diagnosis between 1 January 2018 and 31 December 2025.\n* Any age or sex.\n* Available digital clinical record.\n* Case reported in national surveillance (VE-01).\n* Diagnosed or treated in Costa Rican public health institutions.\n\nExclusion Criteria:\n\n* Cases whose diagnosis was reviewed and reclassified as another disease.",{"count":165,"type":22},130,"OBSERVATIONAL","The goal of this observational retrospective study is to characterize the epidemiologic, clinical, diagnostic, and therapeutic features of Hansen's disease cases in Costa Rica between 2018 and 2025. The main questions it aims to answer are:\n\nWhat are the epidemiologic and clinical characteristics of confirmed Hansen's disease cases in Costa Rica?\n\nWhat diagnostic methods, treatments, complications, and outcomes are observed in routine care?\n\nAll confirmed Hansen's disease cases recorded in national surveillance and with available clinical records during 2018-2025 will be included. Data will be obtained from electronic health records and Ministry of Health reports without participant contact.",[28,169,85,170,84,83],"Hansen's Disease","Lepromatous Leprosy",[28,172,173,174],"Costa Rica","Hansen's disease","Hansen","2026-03-06",{"date":177,"type":33},"2026-03-09",{"date":179,"type":22},"2026-05",{"date":181,"type":22},"2026-12",{"name":183,"class":184},"Caja Costarricense de Seguro Social","OTHER_GOV",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":18,"minAge":193,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":23,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":4},"100612044","integrating-mental-health-into-neglected-tropical-disease-care-in-ghana-100612044","NCT07248462","Integrating Mental Health Into Neglected Tropical Disease Care in Ghana","Integrating Mental Health and Neglected Tropical Disease Interventions to Support Equitable People-Centred Care in Ghana","IMAGINE","Inclusion Criteria:\n\n* Affected by one of the target NTDs (leprosy, LF, buruli Ulcer, Yaws, Onchocersiasis)\n* Living in one of the intervention areas (Bole, Ho, Hohoe, Ellembele)\n* Aged 18 years and above\n\nExclusion Criteria:\n\n\\-","18 Years",{"count":195,"type":22},200,[53],"Background Neglected Tropical Diseases (NTDs) are a group of diseases that are more common among the poorest people in the poorest countries. People affected by these conditions often experience pain, changes in their physical appearance, stigma and discrimination. As a result, they are more likely to experience mental distress including depression and anxiety. It is important that people affected by these conditions are found early, so that they can start treatment to stop the progression of the condition and to support their mental wellbeing. The World Health Organisation recently developed guidance that explains more about including mental health awareness and care as part of the management of people who have these conditions. This is called the Essential Care Package for NTDs, Stigma and Mental Health Conditions. However, so far there has been limited research about 'what works' when providing this package to people who need it.\n\nAim of the study Through this study, we aim to understand 'How can the health system in Ghana provide the essential care package for people affected by skin NTDs for large groups of the population (at scale)?; and how to do this in a way that means everyone can access it (that is fair) and that is effective (works well)?'\n\nMethods\u002F Design In order to do this, we will develop a Ghanaian version of the Essential Care Package and associated resources to support its implementation. We will do this by including people affected by NTDs to help us understand the needs and priorities from their perspective. Working together with researchers, health workers and those who make decisions about health, people affected will be supported to identify their priorities and to take part in developing what will be included in this Ghanaian ECP. This will happen by using creative forms of research that encourage people to participate and through the process, with workshops to include their opinions scheduled throughout.\n\nOnce this has been developed the Government will then start to introduce the Ghanaian ECP in selected study districts. At the same time, we will monitor and evaluate what is happening to understand what parts work well? who they work best for? in what settings? and for how long? We will carry out different types of research to understand who has access to this new package of services? (how fair is it?), how well it works? How the health workers and health system take up and use the new ECP? How the new ECP is rolled out and introduced as part of the health system? And whether it can be maintained and continue beyond the end of the study?\n\nDiscussion Through this study, we hope that people affected by NTDs and mental health conditions will be able to access and use quality health services when they need them; that communities will have a better understanding about NTDs and mental health conditions; and that government departments will work better together to provide care for NTDs and mental health conditions together.",[28,199,120,125,128],"Lymphatic Filariases","2025-11-18",{"date":202,"type":33},"2025-11-25",{"date":204,"type":22},"2025-11",{"date":206,"type":22},"2027-02",{"name":208,"class":40},"Liverpool School of Tropical Medicine",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":17,"sex":18,"minAge":217,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":220,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":41},"100533173","novel-interventions-and-diagnostic-tests-for-leprosy-100533173","NCT06222372","Novel Interventions and Diagnostic Tests for Leprosy","Monitoring the Effect of Prophylactic Interventions in Contacts of Leprosy Patients Including Field-application of a Novel Immunodiagnostic Test in Bangladesh","INDIGO#2","Inclusion Criteria patients:\n\n\\- newly diagnosed multibacillary leprosy patients (BI 1-6)\n\nInclusion Criteria contacts of MB leprosy patients:\n\n* living in the same house (household members)\n* living in a house on the same compound\n* sharing the same kitchen\n* direct neighbors (first neighbors)\n* willing to participate\n* provide informed consent\n\nExclusion Criteria patients:\n\n* refusal of examination of their contacts\n* suffering from the pure neural form of leprosy\n* residing only temporarily in the study area\n* PB leprosy patients\n\nExclusion Criteria contacts:\n\n* diagnosed as leprosy patients during contact examination\n* living less than 100 m away from a patient already included in the study\n* first and second degree relatives of a patient already included in the study\n* refusal informed consent\n* pregnancy\n* tuberculosis or leprosy treatment\n* below 5 years of age\n* known to suffer from liver disease or jaundice\n* residing temporarily in the study area","5 Years",{"count":219,"type":22},1100,[53],"Contact with Mycobacterium leprae (M. leprae) infected individuals is a risk factor for development of leprosy. Thus, detection of asymtomatically M. leprae infected individuals, allowing informed decision making on who needs treatment at a preclinical stage, is vital to interrupt transmission and can help prevent leprosy. In a previous field trial the BCG vaccine was applied alone and combined with a single dose of rifampin (SDR) as prophylactic interventions in contacts of leprosy patients in Bangladesh. Concurrently, blood-derived host immune-profiles specific for M. leprae infection or leprosy disease were assessed in the same population by merging detection of innate, adaptive cellular as well as humoral immunity. This has led to the identification of selected host-immune markers, currently applied in a low complexity lateral flow assay based on up-coverting particles (UCP-LFA), providing a convenient tool to assess M. leprae infection, allowing assessment of efficacy of prophylactic interventions in a point-of-care setting.\n\nThe proposed study aims to determine the effect of post-exposure prophylaxis by SDR on M. leprae infection rate using UCP-LFA before and after prophylaxis.",[28],[224],"leprosy, diagnostics, SDR, post exposure prophylaxis (PEP), biomarkers, UCP-LFA","2025-09-09",{"date":227,"type":33},"2025-09-10",{"date":229,"type":33},"2020-03-04",{"date":231,"type":22},"2026-12-15",{"name":233,"class":40},"Annemieke Geluk",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":18,"minAge":193,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":23,"phases":245,"briefSummary":247,"conditions":248,"keywords":249,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":261},"100457979","phase-2-efficacy-and-tolerability-of-adjunct-metformin-for-multibacillary-leprosy-100457979","NCT05243654","Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy","Efficacy and Tolerability of Adjunct Metformin in Combination With Multidrug Treatment for Multibacillary Leprosy: A Randomized Double-blind, Controlled Proof-of-Concept Phase 2 Trial in Indonesia","MetLep","Inclusion Criteria:\n\n* Participant is a male or female, aged ≥18 and ≤65 years.\n* Participant is newly diagnosed with MB leprosy and has been receiving MDT ≤ 28 days.\n* Participant is willing and able to give informed consent for participation in the trial.\n* Participant is willing to adhere to study follow-up schedule for 48 weeks.\n\nExclusion Criteria:\n\n* Participant has received MDT \\>28 days for the current episode of MB leprosy, prior to study enrolment.\n* Presence of leprosy reaction and\u002For nerve function impairment requiring systemic corticosteroids on screening\u002Fenrolment evaluation.\n* Participants who have been treated for leprosy in the past.\n* Chronic systemic corticosteroid use for any other medical condition on screening evaluation (chronic use defined as ≥ 2 weeks).\n* History of diabetes mellitus or diabetes mellitus diagnosed on screening evaluation (random blood glucose is elevated ≥200 mg\u002FdL (or ≥11,1 mmol\u002FL) or fasting blood glucose ≥ 126 mg\u002FdL (or ≥7.0 mmol\u002FL)).\n* History of hypoglycaemia (random blood glucose \\\u003C55 mg\u002FdL (or \\\u003C3.0 mmol\u002FL).\n* History of cardiac failure, ischaemic heart disease, alcoholism, history of lactic acidosis or states associated with lactic acidosis such as shock or pulmonary insufficiency, and conditions associated with hypoxia.\n* History of intolerance or hypersensitivity to metformin.\n* Estimated glomerular filtration rate (eGFR) ≤30 mL\u002Fmin\u002F1.73m2 calculated by the CKDEPI equation.\n* AST or ALT ≥3 times the upper limit of normal (ULN) on screening evaluation.\n* Any serious medical condition for which participation in the trial, as judged by the investigator or treating physician, could compromise the well-being of the subject or prevent, limit or confound protocol-specified assessments.\n* HIV-positive on screening evaluation.\n* Female participant of childbearing age who is pregnant (clinically confirmed or urine dipstick for human chorionic gonadotrophin hormone) or breastfeeding.\n* Use of metformin within 12 weeks prior to study enrolment.\n* Use of other regular hypoglycaemic agents, including insulin.\n* Participation in another research trial involving an investigational product within 12 weeks prior to study enrolment.","65 Years",{"count":244,"type":22},166,[246],"PHASE2","This trial aims to evaluate the efficacy, tolerability and safety of adjunct metformin added to standard-of-care multi-drug therapy (MDT) in patients with multibacillary leprosy, and explore its effects on immunological endpoints. A double-blind, placebo controlled proof-of-concept trial will be performed in which patients with newly diagnosed multibacillary leprosy will be randomized (1:1) to metformin 1000mg OD versus placebo for 24 weeks in addition to MDT during 48 weeks.\n\nThe main research question is whether adjunctive metformin, combined with MDT, will improve the clinical outcomes of patients with multibacillary leprosy by mitigating leprosy reactions, thereby reducing nerve damage and corticosteroid use and its associated morbidity. The second aim is to explore whether adjunct metformin, added to MDT, has an acceptable tolerability and safety in patients with multibacillary leprosy.",[28,84,119],[28,250,251],"Multibacillary leprosy","Skin-NTD","2025-08-04",{"date":254,"type":33},"2025-08-07",{"date":256,"type":33},"2022-10-01",{"date":258,"type":22},"2026-09-30",{"name":260,"class":40},"Oxford University Clinical Research Unit Indonesia",6,{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":18,"minAge":217,"maxAge":269,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":41},"100579065","rab-32-gene-polymorphisms-as-a-prognostic-factor-in-leprosy-patients-100579065","NCT06819449","Rab 32 Gene Polymorphisms as a Prognostic Factor in Leprosy Patients","Rab 32 Gene Polymorphisms as a Prognostic Factor in Leprosy Patients and Its Relation to Multiple Drug Therapy: Randomized Clinical Trial","Inclusion Criteria:\n\n* Patients of both sexes with positive slit skin smear for m.leprae .\n\nExclusion Criteria:\n\n* Contraindications to Multi drug therapy :\n* Patients with hypersensitivity to sulfa .\n* Patients with hypersensitivity to clofazimine or rifampcin.\n* pregnant or lactating women.","60 Years",{"count":271,"type":22},50,[53],"Mycobacterium leprae is a slow-growing bacillus that causes leprosy. the infection may take two to ten years to incubate. While the exact mechanism of infection transmission is unknown, direct bacillus absorption through the nasal or respiratory mucosa and aerosolized nasal secretions are the most common theories. The bacteria is subsequently transported by the bloodstream to the peripheral nerves, where it can result in tissue damage from painless burns and ulcers as well as irreparable nerve damage that results in a loss of protective feeling.",[28,275],"Mycobacterium Leprae Infection","2025-02-04",{"date":278,"type":33},"2025-02-11",{"date":280,"type":33},"2024-12-20",{"date":282,"type":22},"2025-12-20",{"name":284,"class":40},"South Valley University",{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":17,"sex":18,"minAge":193,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":166,"phases":4,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":41},"100568627","tgf--1-expression-related-gene-polymorphism-100568627","NCT06683690","TGF β 1 Expression Related Gene Polymorphism","TGF β 1 Expression Related Gene Polymorphism and Their Association With Clinical Types of Leprosy","Inclusion Criteria:\n\n* Patients of both sexes with leprosy.\n* Age above 18 years.\n* patients on multidrug therapy of leprosy.\n\nExclusion Criteria:\n\n* Patients with other dermatological disease.\n* Patients with leprosy reaction.\n* Pregnancy and lactation.\n* Patients with autoimmune disease.","50 Years",{"count":294,"type":22},60,"Leprosy is one of the oldest human infectious diseases. It is a chronic infectious contagious, granulomatous disease caused by intracellular bacillus.\n\nMycobacterium leprae, this chronic granulomatous disease presents symptoms that mainly affected the skin, the nervous system and the reticuloendothelial system, also other systems can be affected, such as the upper respiratory tract, bones and joints, eyes and adrenal glands.\n\nTGF- β is a pleiotropic cytokine that employs several functions on different types of cells. The effect of other cytokines may finally modulate the cellular response in the presence of TGF- β, causing a different effect depending on the activation state of the cell involved. In addition, TGF- β promotes the healing of inflamed tissue through the stimulation and regulation of extracellular matrix by fibroblasts, in addition to inducing the proliferation of endothelial cells required for angiogenesis. Thus, TGF- β is able to regulate the expression of other growth factors, increasing their level of activity.",[28],"2024-11-08",{"date":299,"type":33},"2024-11-12",{"date":301,"type":33},"2024-07-10",{"date":303,"type":22},"2025-07-10",{"name":305,"class":40},"Aswan University",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":17,"sex":18,"minAge":193,"maxAge":313,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":316,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":41},"100564290","phase-1-trial-lep-f1--gla-se-in-healthy-adult-in-areas-endemic-for-leprosy-100564290","NCT06627257","Trial LEP-F1 + GLA-SE in Healthy Adult in Areas Endemic for Leprosy","A Phase 1b, Double-Blind, Randomized, Placebo-Controlled, Antigen Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of LEP-F1 + GLA-SE in Healthy Adult Participants in Areas Endemic for Leprosy","Inclusion Criteria:\n\n* Men and women between 18 and 55 years old.\n* They should be in good general health, confirmed by a medical history and physical examination, with negative clinical evaluation for leprosy.\n* Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on study vaccination days (D0, D28, and D56). They must not be breastfeeding and must use at least one method of contraception from the time of study enrollment (Day 0) through 30 days after the last injection if they have sex with men.\n* Screening laboratory tests with normal, within laboratory reference limits for: sodium, potassium, AST, ALT, total bilirubin, alkaline phosphatase, creatinine, glucose, total WBC count, hemoglobin and platelet count. Abnormal results may be repeated at the discretion of the Principal Investigator and\u002For sub-investigators, who may share doubts with the sponsor's Scientific Leader and if necessary, with the DSMB.\n* Negative serological tests for: HIV 1\u002F2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.\n* Normal or not clinically significant urinalysis as determined by the study doctor or designee. Abnormal results may be repeated at the discretion of the Principal Investigator.\n* Must be able to complete the study adverse events diary.\n* Must consent to participate in the study, be able and willing to make all evaluation visits, be accessible by telephone or home visits, and live in the region until study follow-up completion.\n* Having completed the primary vaccination course for Covid 19, at least 14 days before inclusion in the study. If 14 days have not been completed, the participant may be rescheduled for a new eligibility assessment\n\nExclusion Criteria:\n\n* History of infection with Mycobacterium leprae.\n* History of exposure to experimental products containing GLA-SE.\n* History of active tuberculosis or documented recurrence.\n* History of previous infection with other non-tuberculous mycobacteria.\n* Participation in another trial protocol and\u002For receipt of any trial products in the last 3 months prior to screening.\n* Treatment with immunosuppressive drugs (eg, oral or injectable steroids such as prednisone; high-dose inhaled steroids) or cytotoxic therapies (eg, chemotherapy or radiotherapy) within six months prior to screening.\n* Have received blood transfusion within the last 3 months prior to screening.\n* Donated blood products (platelets, whole blood, plasma, etc.) within the last month prior to screening.\n* Received any vaccine 1 month prior to screening or planned immunizations during the follow-up from D0 to D63 and D154 to D168.\n* History of autoimmune disease or other immunosuppressive causes.\n* History of any other uncompensated acute or chronic disease (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disease, uncontrolled hypertension) or use of medications that, in the opinion of the Principal Investigator, may interfere with safety or immunogenicity of the vaccine.\n* Rash, tattoos, or any other dermatological condition that may adversely affect the injection site of the vaccine or interfere with its evaluation.\n* Body mass index (BMI) ≥ 32.\n* Systemic arterial hypertension (systolic \\> 150 or diastolic \\> 95).\n* History of psychiatric illness with current medication use.\n* Alcohol or drug abuse in the last 6 months prior to screening.\n* Chronic smoker (1 pack or more per day).\n* History of previous anaphylaxis or severe allergic reaction to unknown vaccines or allergens.\n* Individuals who do not wish to cooperate with all procedures recommended in the study protocol.","55 Years",{"count":315,"type":22},54,[317],"PHASE1","This is a phase 1b, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of LEP-F1 + GLA-SE compared to placebo administered as three intramuscular (IM) injections in adult participants aged 18 to 55.",[28],"2024-10-02",{"date":322,"type":33},"2024-10-04",{"date":324,"type":22},"2025-01-02",{"date":326,"type":22},"2026-08",{"name":328,"class":40},"The Immunobiological Technology Institute (Bio-Manguinhos) \u002F Oswaldo Cruz Foundation (Fiocruz)"]