Miltefosine Plus IL Pentamidine for Bolivian CL
Phase 2
Completed
- Conditions
- Leishmaniasis, Cutaneous
- Interventions
- Registration Number
- NCT03445897
- Lead Sponsor
- Jonathan Berman
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention miltefosine plus intralesional pentamidine miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
- Primary Outcome Measures
Name Time Method Lesion size 6 months post therapy area of lesion
- Secondary Outcome Measures
Name Time Method 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