NCT00703924

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 5 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to determine the effectiveness and safety 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.

Detailed 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. Subjects will be randomized to receive either WR 279,396 or vehicle placebo; applied twice a day for 20 days.

Conditions

• Cutaneous Leishmaniasis

Interventions

Type	Name	Description
DRUG	WR 279,396	A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion
DRUG	Placebo	Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion

Timeline

• Start date: 2003-03-01
• Primary completion: 2004-11-01
• Completion: 2005-11-01
• First posted: 2008-06-24
• Last updated: 2017-05-30
• Results posted: 2017-02-15

Locations

2 sites across 2 countries: France, Tunisia