Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This protocol will compare topical paromomycin to standard intralesional (IL) antimony (Sb) to placebo for L braziliensis in Bolivia.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion Nacional de Dermatologia
• Treatments: Paromomycin; Pentamidine

Criteria

Inclusion 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.

Exclusion Criteria:

• Previous treatment for leishmaniasis with Sb, pentamidine, amphotericin B, miltefosine, imidazoles, allopurinol in the last 3 months.

• Other diseases that would be likely in the PI's opinion to interact, either positively or negatively, with treatment.