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Pharmacokinetics, Safety, and Efficacy Trial of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream for the Treatment of Cutaneous Leishmaniasis in Panama

NCT01083576 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-07-16

Study results available
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Summary

The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in subjects with cutaneous leishmaniasis (CL).

Conditions

  • Leishmaniasis, Cutaneous

Interventions

DRUG

WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream)

topical application to CL lesions once daily for 20 days

DRUG

Paromomycin Alone Cream (15% paromomycin topical cream)

topical application to CL lesions once daily for 20 days

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Nestor Sosa, M.D. FACP · Instituto Conmemorativo Gorgas de Estudios de la Salud

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-06-30
Completion
2011-07-31

Countries

  • Panama

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 NCT01083576 on ClinicalTrials.gov