| Trial name or title | Pilot study of efficacy of topical nano‐liposomal meglumine antimoniate (Glucantime) or paromomycin in combination with systemic Glucantime for the treatment of anthroponotic cutaneous leishmaniasis (ACL) caused by Leishmania tropica |
| Methods | Randomised, parallel assignment, double‐blind |
| Participants |
Inclusion criteria: aged 12‐60 years; parasitologically proven CL due toL tropica; history of failure to at least one full course of systemic meglumine antimoniate (Glucantime); general good health based on history and physical examination; ≤ 4 lesions; lesion size < 3 cm; signed informed consent voluntarily and knowingly; guardian's signature for volunteer less than 18 years old Exclusion criteria: pregnant or lactating women and those who are planning to be pregnant in next 60 days; use of other types of treatment for CL; involvement in any other drug or vaccine trial during the study period; known heart, kidney, liver diseases based on history and physical exam; abnormal ECG Age: 12‐60 years |
| Interventions |
Group 1: liposomal paromomycin (liposomes containing 10% paromomycin
) + liposomal MA Group 2: liposomal MA (Glucantime) Group 3: placebo + liposomal MA |
| Outcomes | Complete cure equal to complete re‐epithelialisation of all lesions |
| Starting date | March 2011 |
| Contact information | Ali Khamesipour, Tehran University of Medical Sciences |
| Notes | — |
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