Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia (NCT03096457) | Clinical Trial Compass
CompletedPhase 2/3
Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia
Bolivia80 participantsStarted 2017-04-15
Plain-language summary
This protocol will compare topical paromomycin to standard intralesional (IL) antimony (Sb) to placebo for L braziliensis in Bolivia.
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.