The efficacy of topical human amniotic membranemesenchymal stem cell-conditioned medium (hAMMSC-CM) and a mixture of topical hAMMSC-CM + vitamin C and hAMMSC-CM + vitamin E on chronic plantar ulcers in leprosy: A randomized control trial, Journal of Dermatological Treatment,

IntroductionErythema nodosum leprosum (ENL) is an immunological complication of leprosy. ENL results in morbidity and disability and if it is not treated can lead to death. The current treatment consists of thalidomide or high doses of oral corticosteroids for prolonged periods. Thalidomide is not available in many leprosy endemic countries. The use of corticosteroids is associated with morbidity and mortality. Identifying treatment regimens that reduce the use of corticosteroids in ENL is essential. Methotrexate (MTX) is used to treat many inflammatory diseases and has been used successfully to treat patients with ENL not controlled by other drugs, including prednisolone and thalidomide. We present the protocol of the ‘MTX and prednisolone study in ENL’ (MaPs in ENL) a randomised controlled trial (RCT) designed to test the efficacy of MTX in the management of ENL.Methods and analysisMaPs in ENL is an international multicentre RCT, which will be conducted in leprosy referral centres in Bangladesh, Brazil, Ethiopia, India, Indonesia and Nepal. Patients diagnosed with ENL who consent to participate will be randomly allocated to receive 48 weeks of weekly oral MTX plus 20 weeks of prednisolone or 48 weeks of placebo plus 20 weeks of prednisolone. Participants will be stratified by type of ENL into those with acute ENL and those with chronic and recurrent ENL. The primary objective is to determine whether MTX reduces the requirement for additional prednisolone. Patients’ reported outcome measures will be used to assess the efficacy of MTX. Participants will be closely monitored for adverse events.Ethics and disseminationResults will be submitted for publication in peer-reviewed journals. Ethical approval was obtained from the Observational/Interventions Research Ethics Committee of the London School of Hygiene & Tropical Medicine (15762); The Leprosy Mission International Bangladesh Institutional Research Board (in process); AHRI-ALERT Ethical Review Committee, Ethiopia; Ethics Committee of the Managing Committee of the Bombay Leprosy Project; and The Leprosy Mission Trust India Ethics Committee; the Nepal Health and Research Council and Health Research Ethics Committee Dr. Soetomo, Indonesia. This study is registered at www.clinicaltrials.gov. This is the first RCT of MTX for ENL and will contribute to the evidence for the management of ENL.Trial registration numberNCT 03775460.

Background The coronavirus disease 2019 (COVID-19) pandemic has led to governments implementing a variety of public health measures to control transmission and has affected health services. Leprosy is a communicable neglected tropical disease caused by Mycobacterium leprae and is an important health problem in low- and middle-income countries. The natural history of leprosy means that affected individuals need long-term follow-up. The measures recommended to reduce transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can create barriers to health services. We evaluated the impact of the COVID-19 epidemic response on leprosy services and disease management. Methods We conducted a cross-sectional online survey with healthcare professionals in leprosy referral centres. Results Eighty percent of leprosy diagnostic services were reduced. All respondents reported that multidrug therapy (MDT) was available but two reported a reduced stock. Clinicians used alternative strategies such as telephone consultations to maintain contact with patients. However, patients were not able to travel to the referral centres. Discussion This study highlights the effects of the initial phase of the SARS-CoV-2 pandemic on leprosy services in a range of leprosy-endemic countries. Many services remained open, providing leprosy diagnosis, MDT and leprosy reaction medications. Centres developed innovative measures to counter the negative impacts of the COVID-19 pandemic.

Background: Leprosy is a chronic infectious disease caused by Mycobacterium leprae, which tends to attack peripheral nerves and skin. The diagnosis of leprosy is based on the presence of one of three cardinal signs. Early diagnosis of leprosy is critical and is made through clinical examination and investigation. Purpose: To discuss the diagnosis, laboratory examination, and treatment of leprosy, considering that early diagnosis and appropriate treatment are the key elements in breaking the chain of transmission and preventing leprosy patients' disabilities. Review: Leprosy is a chronic granulomatous infectious disease caused by the Mycobacterium leprae. Based on clinical appearance, histopathology findings, and immunological, leprosy is grouped into six forms using the Ridley-Jopling classification, namely Tuberculoid (TT), Borderline Tuberculoid (BT), Borderline-borderline Mid-borderline (BB), Borderline-lepromatous (BL), Subpolar Lepromatous (LLs), and Polar Lepromatous (LLp). Based on the treatment category, leprosy is grouped into paucibacillary (PB) and multibacillary (MB). Leprosy is often diagnosed clinically, and skin scraping smear remains the preferred laboratory method. The negative results of smear skin scraping may not necessarily exclude leprosy. Therefore, a higher sensitivity test might be needed to detect M. leprae. Treatment with Multi-Drug Therapy (MDT) is adjusted based on the type of leprosy, whether it belongs to the PB or MB group. Treatment of PB type, regimens are rifampicin and dapsone, while in MB type, the patients received rifampicin, dapsone, and clofazimine regimens. Conclusion: A proper diagnosis for leprosy, both through physical examination and laboratory examination, is required to determine an effective MDT treatment and break the chain of disease transmission.

Background Leprosy reactions, Type-1 and erythema nodosum leprosum, are immune-mediated complications of leprosy, which play a significant role in the morbidity associated with the disease. A considerable amount of literature has been published on the impact of leprosy in general but few studies focus specifically on leprosy reactions. This study aimed to investigate the impact of leprosy reactions on physical, psychological, and social aspects of the lives of people affected by analysing their life experiences and perspectives about leprosy reactions. Methods/Principal findings This qualitative study involved people affected by leprosy reactions and their family members in two leprosy endemic countries. The data were collected through 66 interviews and 9 focus group discussions (4–6 participants each) in Surabaya, Indonesia, and Purulia, India. Content analysis and conversational analysis were performed. This study found that both types of leprosy reactions were perceived as an unpredictable and painful condition. Leprosy reactions restricted physical activities of the participants, such as going to bathroom, sleeping, eating, and cooking. In the interviews, the respondents expressed a range of emotions and feelings including confusion, sadness, anxiety, and anger. Some recounted that they felt stigmatized and lost opportunities to socialise and earn money. Differences between the two settings were identified. The majority of Indonesian participants preferred to stay at home, and some concealed the diagnosis of leprosy, while most of the Indian respondents continued working up to the time of hospitalization. Conclusion Leprosy reactions are a distressing complication of leprosy and adversely affect the lives of those affected. Individuals reported physical discomfort, distress, anxiety, stigma, and financial hardship and these negative impacts in the physical, psychological, and social spheres reinforced each other. These findings provide important information about a need for early detection and sustained commitment to follow-up care for people with a history of leprosy reactions. More research on new drugs for reactional episodes, tools to measure knowledge, attitude, and practice, and costing study on leprosy reactions treatment are needed. We recommend the development and testing of holistic strategies to improve the management of leprosy reactions.

Background: Erythema nodosum leprosum (ENL) has a chronic and recurrent nature which could reduce patient’s quality of life in addition to the onset of ENL that occurs before, during, or after multidrug treatment, further emphasizing the importance of regular control and education.Purpose:This study aimed to evaluate the epidemiology, onset, duration, and recurrence of ENL. Methods:Data from medical records were obtained for a 3-year retrospective study of multibacillary leprosy patients at the Leprosy Division of the Dermatology and Venereology Outpatient Department, Dr. Soetomo General Hospital Surabaya, with a minimum of 2–5 years follow-up period.Result:The prevalence of  ENL continued to increase almost every year especially in 2017 (32% in 2015; 32% in 2016; and 36% in 2017). ENL most often occurs during the first year of multi-drug therapy (MDT) administration followed by after the release from treatment (RFT) with the latest onset occurring 4 years after RFT. The majority of patients experienced chronic and recurrent reactions with the longest reactions lasting up to 4.5 years (55 months). Conclusion:Knowledge about the onset, duration, and recurrences of ENL are essential, and strict supervision for routine control shall be encouraged to increase the patients’ compliance so as to increase their quality of life.

Background: According to WHO data, the number of new cases of leprosy has decreased in 2019. However, Indonesia continues to provide a significant number of cases. According to statistics, India, Brazil, and Indonesia account for 79 percent of all instances. Purpose: This study aims to describe the profile of leprosy patients, and involves all Dermatology and Venereology Academic Hospitals in Indonesia. Methods: This study was a retrospective study of 2461 patients from Dermatology and Venereology Outpatient Clinic at 13 Academic Hospitals in Indonesia between January 2018 and December 2020. Result: Subjects in this study were dominated by males (66.8%) and aged > 14 years (95.3%). The most common type of leprosy was multibacillary (MB) (86.2%), and erythema nodosum leprosum (ENL) was the most leprosy reaction (20.3%). Majority of the subjects experienced disability in the hands (26.6%), in grade 1. Conclusion: Leprosy cases in Indonesia are mostly experienced by adult males. The most common type of leprosy is MB, with ENL being the most common leprosy reaction. Grade 1 disability is the most prevalent, therefore proper education is necessary to keep patients from progressing to grade 2 disability.

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