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.