Conditions: Leishmaniasis, Cutaneous
Keywords: leishmaniasis cutaneous WR 279,396 paromomycin gentamicin pharmacokinetics safety efficacy military
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1
Healthy volunteers: no

Brief 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.

Arms:
arm 1: All subjects in this one-arm study will receive topical WR 279,396

Interventions: intervention 1: WR 279,396
Intervention descriptions: intervention 1: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days

Protocol document: