Intralesional Antimony for Bolivian Cutaneous Leishmaniasis

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Intralesional injection of antimony has been used for L major from Iran with a modest cure rate [56%: Asilian 2004]. However, this therapeutic approach has been used for L braziliensis from Brazil, with an attractive cure rate after 3 months of 80% [Oliveira-Neto 1997]. Because intralesional Sb injections is the local therapy with the best reported cure rate for South American L braziliensis disease, the species that causes disease in Bolivia, this pilot study of local therapy for bolivian L braziliensis disease will evaluate intralesional Sb therapy.

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

Details

• Lead Sponsor: Fundacion Nacional de Dermatologia
• Collaborators: Hospital Dermatológico de Jorochito; Proyecto OSCAR; The Alfred Berman Foundation for Medical Research; Universidad Mayor de San Simón

Criteria

INCLUSION CRITERIA:

• Gender: Male or female

• Age: >12 yrs of age

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

• 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: therapy with Sb, pentamidine, amphotericin B, miltefosine, imidazoles or allopurinol in the last 3 months

• Concomitant diseases by history that would be likely in the PI's opinion to interact, either positively or negatively, with IL Sb treatment.