Trial | NCT01381055  Report issue

Title

Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis
Double-blind Placebo Controlled Trial Using Pentoxifylline Associated With Pentavalent Antimony in Cutaneous Leishmaniasis

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    164
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.
Study Started
Mar 31
2012
Primary Completion
Jan 31
2015
Study Completion
Oct 31
2015
Last Update
Jan 26
2017
Estimate

Drug Pentoxifylline

Patients with cutaneous leishmaniasis treated with pentavalent antimony/Meglumine antimoniate 20mg/kg/day during 20 days and pentoxifylline pills 400mg three times a day during 20 days.

Drug Placebo

Patients with cutaneous leishmaniasis treated with pentavalent antimony/metilglucamine 20mg/kg/day during 20 days and placebo pills three times a day during 20 days.

Pentoxifylline plus antimony Experimental

Placebo plus antimony Placebo Comparator

Criteria 

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
No Results Posted