Protozoal diseases. Cutaneous Leishmaniasis
Conditions
Interventions
Intervention 1: Intervention: Systemic glucantime 60 mg/kg/day for 21 days with topical liposomal glucantime twice a day for 28 days. Intervention 2: Intervention: Systemic glucantime 60 mg/kg/day for
Treatment - Drugs
Placebo
Intervention: Systemic glucantime 60 mg/kg/day for 21 days with topical liposomal glucantime twice a day for 28 days
Intervention: Systemic glucantime 60 mg/kg/day for 21 days with topical liposomal paromomycine twice a day for 28 days
Control: Systemic glucantime 60 mg/kg/day for 21 days with topical placebo twice a day for 28 days
Sponsors
Mashhad University of Medical sciences
Tehran University of medical sciences
Eligibility
Sex/Gender
All
Age
12 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Male or female aged between 12 to 60 years. 2. Parasitologically proven CL due to L. tropica. 3. History of failure to at least one full course of systemic Glucantime. 4. In general good health based on history and physical examination. 5. Number of lesion at most 4. 6. Lesion size less than 3 cm. 7. Signed informed consent voluntarily and knowingly**. ** Guardian’s signature for volunteer less than 18 years old. Exclusion criteria: 1. Pregnant or lactating women and those who are planning to be pregnant in next 60 days. 2. Use of other types of treatment for CL. 3. Involvement in any other drug or vaccine trial during the study period. 4. Known heart, kidney, liver diseases based on history and physical exam. 5. Abnormal ECG
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete cure equal to Complete Re-epithelization of all lesions. Timepoint: weekly. Method of measurement: Taking digital pictures. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Mahmood reza Jaafari
School of pharmacy, MUMS
Outcome results
None listed