drugset / Trial / NCT03829917
Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis
Phase 2/3
Completed
120 enrolled
Fundacion Nacional de Dermatologia
Alfred Berman Foundation · collabHospital Dermatológico de Jorochito · collabMinisterio de Salud de Bolivia, Programa Nacional de Leishmaniasis · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Cure rate for L braziliensis bolivian CL has been 70%-80% for standard systemic and local monotherapies. It would benefit patients if cure rates could be consistently \>90%, so testing a combination of two treatments is proposed. The most attractive systemic therapy is the only oral agent, miltefosine during 28 days, and the most attractive local therapy is application of Paromomycin cream for 28 days.
Timeline
- Start
- 2019-02-01
- Primary completion
- 2020-12-01
- Completion
- 2020-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Miltefosine | Small molecule | 2.5 mg/kg | Oral |
| Subject | Miltefosine | Small molecule | 50 mg | Oral |
| Subject | Paromomycin | Small molecule | — | — |