Overview

This trial is active, not recruiting.

Condition cutaneous leishmaniasis
Treatments pentoxifylline, placebo
Phase phase 2/phase 3
Sponsor Paulo Roberto Lima Machado
Collaborator Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT)
Start date January 2011
End date January 2014
Trial size 164 participants
Trial identifier NCT01381055, LCPX2011

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
(Placebo Comparator)
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.

Primary Outcomes

Measure
Cure rate or complete cicatrization of the ulcer.
time frame: 6 months

Secondary Outcomes

Measure
Initial cure rate or complete cicatrization of the ulcer
time frame: 2 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Double-blind Placebo Controlled Trial Using Pentoxifylline Associated With Pentavalent Antimony in Cutaneous Leishmaniasis
Principal investigator Paulo Roberto L Machado, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Hospital Universitário Professor Edgard Santos.