Leishmaniasis, Cutaneous
Conditions
Brief summary
Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
Detailed description
Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5). Efficacy and tolerance parameters were assessed. Efficacy was assessed at 1, 3, and 6 months post therapy. Tolerance was assessed on each day therapy was administered.
Interventions
DRUGmiltefosine plus intralesional pentamidine
miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
Sponsors
Jonathan Berman
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* one ulcerative lesion ≤ 900 mm2 in total area, * ≥ 12 years, * parasitologically diagnosed by visualization of amastigotes or culture of promastigotes from lesion material, * no antileishmanial therapy in the last 3 months, * no mucosal lesions, * no history of significant concomitant diseases including immunosuppression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion size | 6 months post therapy | area of lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| systemic adverse effects | days 1 to 28 of therapy | gastrointestinal side effects |
| adverse effects at site | days 1, 3, 5 of therapy | pain, erythema, edema |
Outcome results
None listed