Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis

Paulo Roberto Lima Machado

Status and phase

Completed

Phase 3

Phase 2

Conditions

Cutaneous Leishmaniasis

Treatments

Drug: Pentoxifylline

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01381055

LCPX2011

Details and patient eligibility

About

The purpose of this study is to determine whether pentoxifylline associated to pentavalent antimony has a higher cure rate than pentavalent antimony alone in the treatment of cutaneous leishmaniasis.

Enrollment

164 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
Number of lesions: 1 to 3 ulcerative lesions.
Lesion´s diameter: 1 to 5 cm.
Disease duration: up to three months.

Exclusion criteria

Safety concerns:
- AST, ALT >3 times upper limit of normal range
- Serum creatinine or BUN >1.5 times upper limit of normal range
- Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
- Immunodeficiency or antibody to HIV
- Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
- Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months
Lack of suitability for the trial:
- Negative parasitology (aspirate/biopsy/PCR)or negative Montenegro test
- Any history of prior anti-leishmania therapy
- Any condition which compromises ability to comply with the study procedures
Administrative reasons:
- Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
- Anticipated non-availability for study visits/procedures