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Completed

NCT Number: NCT03096457

Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia

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

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Key information

Conditions

Leishmaniasis, Cutaneous Euglenozoa Infections Infections Leishmania Braziliensis Complex Leishmaniasis Leishmaniasis, American Leishmaniasis, Mucocutaneous Leishmaniasis; American, Cutaneous Parasitic Diseases Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Vector Borne Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Local Palos Blancos, Palos Blancos, La Paz Department, Bolivia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paromomycin sulfate

Drug

topical application 2 times a day during 20 days

Pentamidine isethionate

Drug

3 Intralesional injections at days 1,3 and 5

Placebo

Other

topical application 2 times a day during 20 days

Primary outcomes

  1. Change of Lesion size

    Time frame: 6 months

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

Secondary outcomes

  1. Number of participants with treated-related adverse events

    Time frame: 1 month

    Adverse events will measured according to CTCAE 4.03

Sponsors and collaborators

Lead sponsor

Fundacion Nacional de Dermatologia

Other

Registry information

Official study title

Topical Paromomycin Cream For Bolivian Cutaneous Eishmaniasis: A Controlled Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 30, 2017
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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