Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia

Fundacion Nacional de Dermatologia80 enrolled

Overview

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

Patients will be randomized between Paromomycin cream applied topically once daily for 20 days (group 1--40 patients), pentamidine administered intralesionally at 120 ug/mm2 on days 1, 3, 5 (group 2-20 patients), and cream vehicle applied topically once daily for 20 days (group 3-20 patients). After treatment, all patients will be followed for 1, 3, and 6 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Leishmaniasis, Cutaneous Leishmania Braziliensis Complex Leishmaniasis, American Leishmaniasis; American, Cutaneous

Interventions

Paromomycin SulfateDRUG

topical application 2 times a day during 20 days

Pentamidine IsethionateDRUG

3 Intralesional injections at days 1,3 and 5

PlaceboOTHER

topical application 2 times a day during 20 days

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (2)

Hospital Local Palos Blancos

Palos Blancos, La Paz Department, Bolivia

Hospital Dermatologico de Jorochito

Jorochito, SC, Bolivia

Outcomes

Primary Outcomes

Change of Lesion size

change of lesion area at 6 months after treatment compared to baseline

Time frame: 6 months

Secondary Outcomes

Number of participants with treated-related adverse events

Adverse events will measured according to CTCAE 4.03

Time frame: 1 month

Data from ClinicalTrials.gov

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