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Intralesional Antimony for Bolivian Cutaneous Leishmaniasis

This study has been completed.
Sponsor:
Collaborators:
The Alfred Berman Foundation for Medical Research
Universidad Mayor de San Simón
Hospital Dermatológico de Jorochito
Proyecto OSCAR
Information provided by (Responsible Party):
Fundacion Nacional de Dermatologia
ClinicalTrials.gov Identifier:
NCT01300975
First received: February 17, 2011
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Leishmaniasis
Cutaneous Leishmaniasis
 Drug: pentavalent antimony
Procedure: cryotherapy
Drug: placebo cream
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short Course of Intralesional Antimony for Bolivian Cutaneous Leishmaniasis

Resource links provided by NLM:

MedlinePlus related topics: Leishmaniasis
U.S. FDA Resources

Further study details as provided by Fundacion Nacional de Dermatologia:

Primary Outcome Measures:
  • Complete clinical cure [ Time Frame: six months ] [ Designated as safety issue: No ]
    100% epithelization, complete resolution of swelling and infiltration


Secondary Outcome Measures:
  • EKG changes associated with IL Sb, local reactions to cream and Cryo [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    Ealuation of clinical findings and changes in OKG, lipase and SGOT in patients receiving intralesional antimony


Enrollment: 90
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intralesional antimony
3 intralesional injections of antimony at D1, D3 and D7
 Drug: pentavalent antimony
3 intralesional injections of antimony at D1, D3 and D7
Active Comparator: Cryotherapy
Liquid nitrogen until freezing at DF1 and D14
 Procedure: cryotherapy
Frozing of lesions with liquid nitrogen ad D1 and D14
Placebo Comparator: Topical cream
topical treatment 3 times a day during 21 days with an emollient cream
 Drug: placebo cream
topical emollient crean 3 times a day during 21 days

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Gender: Male or female
  • Age: >12 yrs of age
  • Clinicla presentation: 1-2 ulcerative lesions, each < 30 mm in largest diameter, and with a total lesion area <900 mm2.
  • 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: therapy with Sb, pentamidine, amphotericin B, miltefosine, imidazoles or allopurinol in the last 3 months
  • Concomitant diseases by history that would be likely in the PI's opinion to interact, either positively or negatively, with IL Sb treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300975

Locations
Bolivia
CUNETROP - Universidad Mayor de San Simon
Cochabamba, CB, Bolivia
Hospital Dermatologico de Jorochito
Jorochito, SC, Bolivia
Sponsors and Collaborators
Fundacion Nacional de Dermatologia
The Alfred Berman Foundation for Medical Research
Universidad Mayor de San Simón
Hospital Dermatológico de Jorochito
Proyecto OSCAR
Investigators
Study Chair: Jonathan Berman, MD PhD ABF
Study Director: Jaime Soto, MD Fundacion Nacional de Dermatologia
Principal Investigator: Ernesto Rojas, MD Universidad Mayor de San Simón
  More Information

Publications:

Responsible Party: Fundacion Nacional de Dermatologia
ClinicalTrials.gov Identifier: NCT01300975     History of Changes
Other Study ID Numbers: ABF-BO-2010-101
Study First Received: February 17, 2011
Last Updated: July 3, 2012
Health Authority: Bolivia: Ethics Committee

Keywords provided by Fundacion Nacional de Dermatologia:
Leishmaniasis
intralesional antimony
cryotherapy

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
 Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013