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Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World

Cutaneous Leishmaniasis Clinical Trial

Official title:
Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: a Phase 2 Study in the Old World

Clinical Trial Summary

The objective of this study is to determine the effectiveness and toxicity of WR 279,396, a topical cream for the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo control under double-blind conditions in a local population group in Tunisia where leishmaniasis is endemic.

Clinical Trial Description

WR 279,396 is a paromomycin-based topical cream that has shown some suggestion of being effective for the treatment of non-serious, non-complicated cutaneous leishmaniasis in previous clinical studies. The goal of this study is to expand those observations in a larger, more rigorous study to clearly define the efficacy of this product and collect information about adverse effects. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00703924
Study type Interventional
Source U.S. Army Medical Research and Materiel Command
Contact
Status Completed
Phase Phase 2
Start date March 2003
Completion date January 2005
View Details
See also
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