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Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis

NCT00884377 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-01-02

Study results available
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Summary

This study serves to compare the effectiveness of treating cutaneous leishmaniasis with either intravenous sodium stibogluconate or direct heat therapy using the ThermoMed-TM device.

Conditions

  • Cutaneous Leishmaniasis

Interventions

DRUG

Sodium stibogluconate (Pentostam)

intravenous 20 mg/kg/day for 10 days

DEVICE

ThermoMed

ThermoMed heat treatment device, one treatment

Sponsors & Collaborators

  • Walter Reed Army Medical Center

    collaborator FED

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • COL Naomi Aronson, M.D. · Uniformed Services University of the Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2009-01-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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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 NCT00884377 on ClinicalTrials.gov