NCT01300975

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

February 2, 2021

Status Verified

July 1, 2018

Enrollment Period

1.5 years

First QC Date

February 17, 2011

Last Update Submit

February 1, 2021

Conditions

LeishmaniasisCutaneous Leishmaniasis

Keywords

Leishmaniasisintralesional antimonycryotherapy

Outcome Measures

Primary Outcomes (1)

  • Complete clinical cure

    100% epithelization, complete resolution of swelling and infiltration

    six months

Secondary Outcomes (1)

  • EKG changes associated with IL Sb, local reactions to cream and Cryo

    six months

Study Arms (3)

Intralesional antimony

EXPERIMENTAL

3 intralesional injections of antimony at D1, D3 and D7

Drug: pentavalent antimony

Cryotherapy

ACTIVE COMPARATOR

Liquid nitrogen until freezing at DF1 and D14

Procedure: cryotherapy

Topical cream

PLACEBO COMPARATOR

topical treatment 3 times a day during 21 days with an emollient cream

Drug: placebo cream

Interventions

pentavalent antimonyDRUG

3 intralesional injections of antimony at D1, D3 and D7

Intralesional antimony
cryotherapyPROCEDURE

Frozing of lesions with liquid nitrogen ad D1 and D14

Cryotherapy
placebo creamDRUG

topical emollient crean 3 times a day during 21 days

Topical cream

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CUNETROP - Universidad Mayor de San Simon

Cochabamba, CB, Bolivia

Location

Hospital Dermatologico de Jorochito

Jorochito, SC, Bolivia

Location

Related Publications (3)

  • Chaabane H, Masmoudi A, Dammak A, Kchaou W, Akrout F, Zribi M, Boudaya S, Turki H. [Cryotherapy with or without intralesional antimony in the treatment of cutaneous leishmaniasis]. Ann Dermatol Venereol. 2009 Mar;136(3):278-9. doi: 10.1016/j.annder.2008.09.016. Epub 2008 Dec 3. No abstract available. French.

    PMID: 19328314BACKGROUND

  • Ranawaka RR, Weerakoon HS. Randomized, double-blind, comparative clinical trial on the efficacy and safety of intralesional sodium stibogluconate and intralesional 7% hypertonic sodium chloride against cutaneous leishmaniasis caused by L. donovani. J Dermatolog Treat. 2010 Sep;21(5):286-93. doi: 10.3109/09546630903287445.

    PMID: 20438389RESULT

  • Soto J, Rojas E, Guzman M, Verduguez A, Nena W, Maldonado M, Cruz M, Gracia L, Villarroel D, Alavi I, Toledo J, Berman J. Intralesional antimony for single lesions of bolivian cutaneous leishmaniasis. Clin Infect Dis. 2013 May;56(9):1255-60. doi: 10.1093/cid/cit049. Epub 2013 Feb 6.

    PMID: 23390069DERIVED

MeSH Terms

Conditions

LeishmaniasisLeishmaniasis, Cutaneous

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Euglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jonathan Berman, MD PhD

    ABF

    STUDY CHAIR

  • Jaime Soto, MD

    Fundacion Nacional de Dermatologia

    STUDY DIRECTOR

  • Ernesto Rojas, MD

    Universidad Mayor de San Simón

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 23, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

February 2, 2021

Record last verified: 2018-07

Locations

BO(2)