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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.
Details
| Lead sponsor | University of Brasilia |
|---|---|
| Phase | Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 160 |
| Start date | 2015-08 |
| Completion | 2026-08 |
Conditions
- Leishmaniasis
Interventions
- Meglumine antimoniate
- Miltefosine
- Pentoxifylline
Primary outcomes
- Cure — 90 days
Complete healing of previous lesions until the 90th day after the begin of the treatment - Failure — 90 days
Lesions fail to heal until the 90th day after the begin of the treatment - Relapse — 90 days
Lesions that reappear on the scar of a previously healed lesion
Countries
Brazil