View clinical trials related to Leishmaniasis, Cutaneous.
Filter by:Primary Objectives: Assess whether CL (caused by Leishmaniasis major) lesions treated with WR279396 improved the cosmetic outcome compared with no treatment (natural healing)
The purpose of this randomized, open label clinical trial is to determine if oral miltefosine is a safe and effective alternative, compared with parenteral meglumine antimoniate for the treatment of pediatric Cutaneous caused by L. Viannia species in Colombia.
Background: Cutaneous Leishmaniasis is a worldwide disease, endemic in over 88 countries, that has shown an increasing incidence over the last many decades. For the last 60 years antimony compounds are considered the treatment of choice. Though their use is expensive, cumbersome, has many adverse effects and not effective in all patients, the search for a better alternative is still going on. Low dose antimony compounds in combination with several agents have shown promise of reducing adverse effects of antimony compounds without compromising efficacy. Allopurinol is one such agent which though promising lacks randomized, controlled trials to prove efficacy. The main objective of this study is to evaluate low dose sodium stibogluconate in combination with allopurinol and to compare it with high dose sodium stibogluconate in terms of efficacy and adverse effects. Methods and design: A multi-center randomized, controlled trial including 620 patients from endemic areas for Leishmaniasis in Pakistan will be undertaken to assess the research question. Parasitologically confirmed cutaneous leishmaniasis will be included in the study. After evaluating the inclusion/exclusion criteria patients will be randomized to receive either meglumine antimoniate (20 mg/kg/day/intramuscular, till clinical resolution or a maximum of 28 days) or combination of meglumine antimoniate (10 mg/kg/day intramuscular) and allopurinol (20 mg/kg/day/oral) till clinical resolution or a maximum of 28 days. During treatment patients will be admitted to hospital and monitored daily for the presence of adverse effects. Follow up period will last six months during which patients will visits the research centers for assessment of healing process at monthly intervals.
Cutaneous leishmaniasis (CL) is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence the last two decades. It is estimated that in 2005, about of 20,000 new cases of CL were diagnosed in Colombia. So far, pentavalent antimony compounds have been considered the treatment of choice with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their adverse events and disadvantages. Previous studies have shown that miltefosine could be a potential alternative of treatment for CL. The main objective of this study is to evaluate the efficacy and safety of miltefosine or thermotherapy for the treatment for CL. In this study the efficacy of oral treatment of miltefosine 150 mg/day for 28 days or a thermotherapy device used for one session at 50 celsius degrees during 30 seconds will be compared with the standard treatment of intramuscular injections of 20 mg/Kg/day of pentavalent antimonials (GlucantimeÒ) for 20 days in CL parasitologically proven patients. This trial will be conducted according to the International approved GCP (Good Clinical Practice) guidelines.
The purpose of this project is to investigate the efficacy of early, empiric anti-helminthic therapy combined with standard pentavalent antimony in the treatment of subjects co-infected with helminths and cutaneous leishmaniasis caused by L. brasiliensis. The study hypothesis is that early intervention with antihelminthic therapy will improve response rates to antimony in subjects with cutaneous leishmaniasis.
Cutaneous leishmaniasis is a parasitic skin lesion caused by different species of Leishmania and transmitted by the bite of infected sand flies. Leishmaniasis is exist in 88 countries, pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been used as a standard treatment for this disease for last 80 years. Pentavalent antimonials are only available as injectable, which is painful, toxic, not affordable and moreover is not always effective even sometimes with several courses of treatment. Many different modalities are used to treat the disease with little success. Miltefosine is drug and has recently been shown to be effective in the treatment cutaneous leishmaniasis in Colombia. The molecular mechanisms that contribute to this effectiveness are not clearly understood. Only a well designed, randomized clinical trial can precisely evaluate the efficacy of any therapeutic modalities in cutaneous leishmaniasis. In this study the efficacy of oral treatment of miltefosine 2.5 mg per Kg body weight for 4 weeks will be compared with standard treatment of intramuscular injections of 60 mg/kg/day glucantime for 2 weeks in ACL parasitologically proven patients. At 8 weeks after the initiation of the treatment any patient in the group who received miltefosine and has not responded to the treatment will be treated with the standard intramuscular injections of 60 mg/kg/day glucantime for 2 weeks. The clinical trial will be carried out according to the International approved GCP (Good Clinical Practice) guide lines.
This study will examine why some people who become infected with the leishmaniasis parasite develop skin lesions and others do not. The parasite that causes leishmaniasis is transmitted by the bite of a sandfly. It can cause skin lesions that may persist for several months, spread to other parts of the body, and become infected with bacteria. Treated with medicine, leishmaniasis can be cured completely. People 1 year of age and older who live in the Mali villages of Kemena or Sougoula may be eligible for this study. Participants are injected with a small amount of inactive parasites into the skin of their arm. People who have a reaction to the test, and thus have been exposed to the parasite, are examined for skin lesions. Their lesions, if any, are evaluated and treated, and their participation in the study ends. Participants who do not react to the skin test are examined for skin lesions every month for 5 months. Those who are 18 years of age or older and have mild leishmaniasis skin lesions may have a small amount of fluid injected into a lesion in order to remove parasites for laboratory analysis. Patients' lesions may be photographed to compare what they look like before and after treatment. Lesions are treated with an ointment containing an antibiotic and a disinfectant twice a day for 20 days. The lesions are examined 1 and 3 weeks after treatment is completed to see if the disease has been cured. A few months later, the skin test is repeated to determine whether the person has been exposed to parasites over the past year. A blood sample may be drawn from some participants, depending on whether they have a reaction to the second skin test and whether they have developed skin lesions. The sample is drawn only from patients 18-65 years of age. Some blood drawn for the study may be used for genetic tests.
The purpose of this study is to determine whether low-dose pentavalent antimony is equally effective when compared to the standard-dose regimen in patients with cutaneous leishmaniasis. The study will be done in a field clinic in the state of Bahia, Brazil.
Cutaneous leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis. A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be administered daily and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The healing process of the ulcer, the health of the participants, recidivisms and/or reinfection will also be assessed. The evolution of the ulcers will be photographically registered. In the case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic alternative for one of the most important public health problems in many countries will be available to patients.
This study will test whether addition of imiquimod to standard antimony therapy provides a significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our previous results, we hypothesize that lesions in patients who receive the combined treatment of pentavalent antimony and imiquimod as a first line therapy will resolve more rapidly and produce less scarring than treatment with pentavalent antimony alone.