Safety, Efficacy, and PK of Topical Paromomycin/Gentamicin Cream for Treatment of Cutaneous Leishmaniasis — WRNMMC  

Leishmaniasis, Cutaneous Clinical Trial

Official title: An Open-Label Clinical Study to Examine the Safety, Efficacy, and Pharmacokinetics of WR 279,396 (Paromomycin + Gentamicin Topical Cream) for the Treatment of Cutaneous Leishmaniasis at Walter Reed National Military Medical Center (WRNMMC)

Status Terminated

Clinical Trial Summary

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

Clinical Trial Description

Subjects will be screened over a period of up to 14 days prior to first treatment, and will receive treatment once daily for 20 days. Safety will be assessed by monitoring AEs, lesion site reactions, vital signs, hematology, and blood chemistry parameters.

Complete cure of ulcerated lesions is defined as 100% re-epithelialization or a measurement of ulceration of 0 x 0 mm. non-ulcerated treated lesions will also be measured to monitor total area of exposure of lesions to study drug and will be evaluated for cure (the absence of raised area on the skin).

Follow-up evaluations will be at 28 +2 days, 60 +7 days and 100 +14 days. ;

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Cutaneous

• NCT number: NCT01140191
• Study type: Interventional
• Source: U.S. Army Medical Research and Development Command
• Status: Terminated
• Phase: Phase 2
• Start date: September 2013
• Completion date: September 2014