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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.
Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.
Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.
Hospital Universitário de Brasília
Brasília, Federal District, Brazil
Cure
Complete healing of previous lesions until the 90th day after the begin of the treatment
Time frame: 90 days
Failure
Lesions fail to heal until the 90th day after the begin of the treatment
Time frame: 90 days
Relapse
Lesions that reappear on the scar of a previously healed lesion
Time frame: 90 days
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