NCT01140191

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Leishmaniasis, Cutaneous

Interventions

Type	Name	Description
DRUG	WR 279,396	Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-12-01
• Completion: 2014-09-01
• First posted: 2010-06-09
• Last updated: 2019-11-22
• Results posted: 2017-03-22

Locations

1 site across 1 country: United States