Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia

NCT03096457 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-02-02

No results posted yet for this study

Summary

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

Conditions

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

Interventions

DRUG

Paromomycin Sulfate

topical application 2 times a day during 20 days

DRUG

Pentamidine Isethionate

3 Intralesional injections at days 1,3 and 5

OTHER

Placebo

topical application 2 times a day during 20 days

Sponsors & Collaborators

  • Fundacion Nacional de Dermatologia

    lead OTHER

Principal Investigators

  • JAIME SOTO, MD · Fundacion Nacional de Dermatologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-15
Primary Completion
2018-03-18
Completion
2018-04-01

Countries

  • Bolivia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03096457 on ClinicalTrials.gov