Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia

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

Detailed Description
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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.

Official Title
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Topical Paromomycin Cream For Bolivian Cutaneous Eishmaniasis: A Controlled Study

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

Intervention / Treatment
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* Drug: Paromomycin Sulfate
* Drug: Pentamidine Isethionate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - Paromomycin cream<br>40 subjects will be included to receive 15% paromomycin in aquafilm base twice a day during 20 consecutive days. The lesion will be cleaned , then, a generous amount of the study drug (an amount sufficient to cover the area of the ulcer and the lesion border) will be applied to the lesion and rubbed into the ulcer using a gloved finger by a member of the clinical study staff. After application of the study drug, the patient will be observed for 15 minutes for signs of adverse events. If there are no signs of local toxicity, the area of the ulcer will be covered with extra study drug. For Days 2-20, the study drug will be applied and the lesion covered with a sterile gauze and tape dressing as on Day 1. | Drug: Paromomycin Sulfate<br>* topical application 2 times a day during 20 days<br>|
| Active Comparator: Group 2. Local Injectable Pentamidine<br>20 subjects will be included to receive IL pentamidine [Pentacarinat® Sanofi-Aventis: 30 mg/ml] will administered at a dose of 120 ug (4 ul) per mm2 of lesion area 3 times (on days 1, 3, and 5) as per our previous experience. A small button of Xylocaine® will be applied by means of a thin needle at the four cardinal points of the lesion and then a small gauge (23g) needle will introduce the drug in each cardinal point. The needle will be moved in all directions to infiltrate of whole lesion and surrounding infiltrated area. | Drug: Pentamidine Isethionate<br>* 3 Intralesional injections at days 1,3 and 5<br>|
| Placebo Comparator: Group 3. Vehicle control<br>10% Urea en parafilm cream will be used in similar ways as paromomycin cream in group 1 | Other: Placebo<br>* topical application 2 times a day during 20 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Lesion size | change of lesion area at 6 months after treatment compared to baseline | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treated-related adverse events | Adverse events will measured according to CTCAE 4.03 | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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leishmaniasis, L.braziliensis, paromomycin cream, intralesional pentamidine, leishmaniasis local therapy