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Add-on Study of Pentoxifylline in Cutaneous Leishmaniasis

NCT01464242 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2016-08-23

No results posted yet for this study

Summary

The purpose of this study is to determine whether adding pentoxifylline to treatment of American cutaneous leishmaniasis with meglumine antimoniate increases the rate and speed of clinical response without diminishing safety, and to identify immune correlates of the healing response.

Conditions

  • Cutaneous Leishmaniasis

Interventions

DRUG

Meglumine antimonate

Glucantime® 20mg/kg/day IM daily for 20 days

DRUG

Placebo

Placebo 400mg orally 3 times a day for 20 days

DRUG

Pentoxifylline

Pentoxifylline 400mg orally 3 times a day for 20 days

Sponsors & Collaborators

  • Centro Internacional de Entrenamiento e Investigaciones Médicas

    lead OTHER

Principal Investigators

  • Nancy C Saravia, PhD · Centro Internacional de Entrenamiento e Investigación Médica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-01-31
Completion
2015-12-31

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01464242 on ClinicalTrials.gov