A phase II multicenter randomized study to evaluate the safety and efficacy of combining thermotherapy and a short course of miltefosine for the treatment of uncomplicated cutaneous leishmaniasis in the New World.

BACKGROUND: Systemic pentavalent antimonials, mainly meglumine antimoniate, continue to be the first-choice drugs for treatment of cutaneous leishmaniasis (CL) despite their toxicity, difficulty of administration and high cost. In the search for therapeutic alternatives, combining two treatment interventions has emerged as a potential alternative to either reduce the use of antimonials with the associated toxicities, or to increase efficacy. Here, we report the results of a recently completed trial assessing the efficacy and safety of a combination of thermotherapy (TT) plus a short course of miltefosine (MLT) for the treatment of uncomplicated CL in Colombia and Peru. METHODS: A multicenter, randomized, evaluator-blinded, phase II, controled clinical trial was conducted. Adult volunteers with a parasitologically confirmed diagnosis of uncomplicated CL were randomly allocated to receive either a single session of TT or a combination of TT plus a short course of MLT (3 weeks). Therapeutic response outcomes and safety were assessed. RESULTS: 130 subjects were included in the study, of whom 64 were randomly assigned to the TT arm and 66 to the TT + MLT arm. Cure at 3 months' follow-up was achieved in 57.8% (n = 37) and 80.3% (n = 53) in the TT and TT + MLT groups, respectively, in the intention to treat analysis. The TT + MLT regimen was better that TT alone (p = 0.0055). The presence of vesicles at the site of heat application was the most common adverse event reported associated with the use of TT; while vomiting (31.8%) and elevation of liver enzymes (28.8%) were the most frequent adverse events reported associated with the use of MLT. CONCLUSION: The combination of TT plus a short course of MLT was shown to be significantly better than TT alone for the treatment of uncomplicated CL in the New World. TRIAL REGISTRATION: Registered in clinicaltrials.gov NCT02687971.

American cutaneous leishmaniasis in Guyana, South America.

The 185 patients who presented at the dermatology clinic of Georgetown Public Hospital, Guyana, between 1992 and 1998, with skin ulcers indicative of American cutaneous leishmaniasis (ACL) were retrospectively reviewed. The laboratory-confirmed cases of ACL were identified and the corresponding data were analysed for risk factors such as age, gender, areas of residence and of possible exposure to the causative agent (Leishmania braziliensis guyanensis), ethnic origin, longevity of the ulcers, and treatment regimes prior to the definitive diagnosis. Eighty-one (43%) of the 185 subjects were confirmed to be infected with Le. b. guyanensis. Although 53 (66%) of the cases lived in or close to the capital city, Georgetown, most of the cases had travelled to (and probably been infected in) region X in the interior of Guyana (32%) or regions VII (23%), VIII (23%), IX (11%), VI (5%), I (3%) or III (3%), usually because they were involved in the mining (41%) or lumber (21%) industries, the army or hunting. Almost all (95%) of the cases were male and most (58%) were aged 20-39 years. In general, the cases had had their skin lesions for many days before presenting for treatment: 46% for 1-5 weeks and 3% for > 6 months. Prior to presentation at the clinic, many of the cases had attempted to cure themselves, using local herbal remedies (37%), antibiotics and antifungal remedies (39%), other creams (5%), household chemicals (9%) or miscellaneous remedies such as lead salts (especially lead sulphate) and battery acid, all without success. Recommendations are made for an epidemiological study of active ACL among forest workers, eco-tourists and residents of high-risk areas. Diagnostic centres need to be sited in the regions most at-risk, particularly in or near environments in which the main vectors - sandflies such as Lutzomyia umbratilis, Lu. anduzei and Lu. whitmani - are known to be prevalent.

Leishmaniasis cutánea en la provincia de Toledo. Estudio de 43 pacientes / Cutaneous leishmaniasis in the Toledo province. A study of 43 patients

Se estudiaron 43 pacientes diagnosticados de leishmaniasis cutánea (botón de Oriente) que acudieron a la consulta de dermatología del Hospital Virgen de la Salud entre enero de 1990 y diciembre de 1997. Recogimos los siguientes datos clínicos: sexo, edad, número de lesiones, tiempo de evolución, forma clínica, tamaño y localización. El diagnóstico fue por biopsia cutánea o hallazgo del microorganismo en frotis de la lesión. Encontramos una alta proporción de mujeres (70 %) con dos picos de frecuencia en la edad de los pacientes, uno en menores de 14 años (30 %) y el otro entre 61 y 75 años (30 %).La lesión era única en casi todos los pacientes (91 %). El tiempo de evolución de las lesiones presentaba dos picos de máxima frecuencia (6 y 12 meses). La localización era fundamentalmente en áreas fotoexpuestas: 75 % en cara y 19 % en extremidades. La forma clínica era polimorfa. La forma papulonodular eritematosa con costra en superficie fue la más observada, con un tamaño entre 0,3 y 5 cm. La infiltración intralesional de antimoniales pentavalentes fue el tratamiento más empleado, con resultado satisfactorio. Discutimos los resultados de este trabajo y los comparamos con otras revisiones publicadas (AU)