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

• Status: Recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Brasilia
• Treatments: Meglumine Antimoniate; Miltefosine; Pentoxifylline

Criteria

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.