Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis

January 25, 2017 updated by: Paulo Roberto Lima Machado

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

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 Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tancredo Neves/Bahia
      • Corte de Pedra, Tancredo Neves/Bahia, Brazil, 40000
        • Posto de Saúde de Corte de Pedra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pentoxifylline plus antimony
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 plus antimony
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure rate or complete cicatrization of the ulcer.
Time Frame: 6 months

All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.

Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements.

6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial cure rate or complete cicatrization of the ulcer
Time Frame: 2 months

All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.

Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements

2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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