The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil

The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: An Open-label, Randomized Clinical Trial in Brazil

Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse effects. This interventional study consists in a randomized clinical trial to access efficacy and safety of the association of miltefosine and pentoxifylline compared to meglumine antimoniate and pentoxifyline.

Inclusion Criteria:

• Mucosal and/or cutaneous leishmaniasis, not treated or at least 6 months without any treatment to leishmaniasis;
• For patients with cutaneous lesions: duration of disease longer then a 1 month and shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm;
• Ages between 18 and 80 years old;
• Fertile female patients should use at least two contraceptive methods (hormonal and barrier);
• Agree to participate in the study and sign the informed consent term.

Exclusion Criteria:

• Use of any leishmanicidal drugs six months prior;
• Clinical or laboratorial evidences of electrocardiographic disorders;
• Renal, hepatic, cardiac diseases, uncontrolled diabetes or AIDS;
• Hypersensitivity to meglucamine antimoniate;
• Pregnancy or lactation;
• Fertile females that do not agree to use contraceptive methods;
• Patients that do not agree to the informed consent term.