Conditions: Cutaneous Leishmaniasis
Keywords: cutaneous leishmaniasis topical treatment safety efficacy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 92
Healthy volunteers: no

Brief 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.

Arms:
arm 1: WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin arm 2: Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.

Interventions: intervention 1: WR 279,396 intervention 2: Placebo
Intervention descriptions: intervention 1: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion intervention 2: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion

Protocol document: