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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02530697

Enrollment

160

Registered

2015-08-21

Start date

2015-08-31

Completion date

2026-08-31

Last updated

2024-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leishmaniasis

Keywords

Leishmaniasis, Mucocutaneous, Miltefosine, Pentoxifylline

Brief 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.

Interventions

DRUGMeglumine antimoniate

20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.

DRUGMiltefosine

Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.

DRUGPentoxifylline

Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Relapse	90 days	Lesions that reappear on the scar of a previously healed lesion
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026