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Intralesional Antimony for Bolivian Cutaneous Leishmaniasis

NCT01300975 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-02-02

No results posted yet for this study

Summary

Intralesional injection of antimony has been used for L major from Iran with a modest cure rate \[56%: Asilian 2004\]. However, this therapeutic approach has been used for L braziliensis from Brazil, with an attractive cure rate after 3 months of 80% \[Oliveira-Neto 1997\]. Because intralesional Sb injections is the local therapy with the best reported cure rate for South American L braziliensis disease, the species that causes disease in Bolivia, this pilot study of local therapy for bolivian L braziliensis disease will evaluate intralesional Sb therapy.

Conditions

  • Leishmaniasis
  • Cutaneous Leishmaniasis

Interventions

DRUG

pentavalent antimony

3 intralesional injections of antimony at D1, D3 and D7

PROCEDURE

cryotherapy

Frozing of lesions with liquid nitrogen ad D1 and D14

DRUG

placebo cream

topical emollient crean 3 times a day during 21 days

Sponsors & Collaborators

  • The Alfred Berman Foundation for Medical Research

    collaborator UNKNOWN

  • Universidad Mayor de San Simón

    collaborator OTHER

  • Hospital Dermatológico de Jorochito

    collaborator UNKNOWN

  • Proyecto OSCAR

    collaborator UNKNOWN

  • Fundacion Nacional de Dermatologia

    lead OTHER

Principal Investigators

  • Jonathan Berman, MD PhD · ABF

  • Jaime Soto, MD · Fundacion Nacional de Dermatologia

  • Ernesto Rojas, MD · Universidad Mayor de San Simón

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-07-31
Completion
2012-07-31

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 NCT01300975 on ClinicalTrials.gov