Overview

Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis

Status:
Completed
Trial end date:
2020-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fundacion Nacional de Dermatologia
Collaborators:
Alfred Berman Foundation
Hospital Dermatológico de Jorochito
Ministerio de Salud de Bolivia, Programa Nacional de Leishmaniasis
Treatments:
Miltefosine
Paromomycin
Criteria
Inclusion and exlusion Criteria:

- Gender: Male or female

- Age: >12 yrs of age

- Presentation: 1-to-2 ulcerative lesions, each < 30 mm in largest diameter and with a
total lesion area <900 mm2.

- Parasitology: Parasitological confirmation of the lesion will be made by visualization
or culture of Leishmania from the biopsy or aspirate of the lesion.

- Previous treatment for leishmaniasis:

- No specific or putatively specific therapy (Sb, pentamidine, amphotericin B,
miltefosine, imidazoles, allopurinol) in the last 3 months

- Other diseases: No concomitant diseases by history that would be likely in the PI's
opinion to interact, either positively or negatively, with treatment.