Tofacitinib Associated With Meglumine Antimoniate in Cutaneous Leishmaniasis (CLTofa23)
Cutaneous Leishmaniasis, American
About this trial
This is an interventional treatment trial for Cutaneous Leishmaniasis, American focused on measuring Cutaneous Leishmaniasis, meglumine antimoniate, tofacitinib
Eligibility Criteria
Inclusion Criteria: Subjects with CL of both sexes with disease duration between 30 and 90 days. Patients with CL will be treatment-naïve for leishmaniasis. Individuals will be explained about the nature of the study and will only be included if they agree to participate and sign the Free and Informed Consent Form. Exclusion Criteria: Patients under the age of 18 and pregnant women will not participate in the study considering the need to withdraw 30 ml of blood to carry out the studies of the immune response. Patients over 60 years old, debilitating chronic diseases such as heart failure, liver failure, kidney failure, HIV infection and use of immunosuppressant drugs will also not participate in the study.
Sites / Locations
- Corte de Pedra Health Post
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo and Sbv
Tofacitinib and Sbv
Eleven CL patients will receive meglumine antimoniate by EV route at 20mg/kg/day, for 20 days.
Eleven CL patients will receive oral tofatinib (10mg daily for 30 days) associated to meglumine antimoniate by EV route at 20mg/kg/day, for 20 days.