Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis

• Cure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Re-epithelizations of mucosal ulcers or regression of symptoms
  
  

• Adverse effects [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  laboratory tests of blood, kidney, liver and cardiac functions, partients will be asked about nausea, vomiting, diarrhea, myalgia, or other symptoms
  
  

Drug: Miltefosine
1 Capsule of 50mg, taken orally 2 times a day for 28 days
Other Name: Impavido

Mucosal leishmaniasis is a rare form of the disease, that affects only 6% of the patients with cutaneous leishmaniasis in the New World. It causes deformities and may be lethal if not treated. It is part of the neglected tropical diseases because on the past sixty years there was few progress regarding other treatment options or improvement at quality of life of its patients. Also, there was little interest from the pharmaceutical industry and government authorities to develop new researches. The standard treatment, meglumine antimoniate, is toxic, invasive, requires trained personnel and has many adverse effects and restrictions. On the other hand, miltefosine is the first oral drug to demonstrate efficacy against mucocutaneous leishmaniasis. Few clinical trials have being performed in Central and South American countries, but so far, just one involved mucosal leishmaniasis patients, and compared miltefosine to amphotericin B. None studies comparing its efficacy to the standard treatment have being done.