Anthroponotic cutaneous leishmaniasis Infections and Infestations Leishmaniasis
Conditions
Interventions
Group 1: Intramuscular glucantime (meglumine antimonate) 60 mg/kg/day for 14 days plus imiquimod 5% cream applied 3 times/week for 4 weeks
Group 2: Glucantime with the same dosage and duration plus pl
Sponsors
World Health Organisation - Eastern Mediterranean Regional Office (EMRO) (Egypt)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with anthroponotic cutaneous leishmaniasis caused by leishmania tropica 2. Aged 12 to 60 years 3. With less than 5 lesions each less than 5 cm in greatest diameter and duration less than 6 months
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Duration of lesions more than 6 months 3. Number of lesions more than 5 4. Lesions greater than 5 cm in their largest diameter 5. History of any full course of standard treatment (antimonials) 6. History of allergy to glucantime 7. Serious systemic illnesses (as judged by the physician) 8. Participation in any drug trials in the last 60 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The rate of clinical response (clinical cure, improvement, or failure) with the two above mentioned treatment regimens on 4 and 8 weeks after beginning treatment for acute anthroponotic cutaneous leishmaniasis 2. The rate of parasitological cure with the two above mentioned treatment regimens on 4 and 8 weeks after beginning treatment for acute anthroponotic cutaneous leishmaniasis 3. The rate of relapse with the two above mentioned treatment regimens 20 weeks after beginning treatment for acute anthroponotic cutaneous leishmaniasis 4. The rate of adverse events with the two above mentioned treatment regimens for acute anthroponotic cutaneous leishmaniasis | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of reduction in the size of lesions with the two above mentioned treatment regimens on 4 and 8 weeks after beginning treatment for acute anthroponotic cutaneous leishmaniasis. | — |
Countries
Iran
Outcome results
None listed