NCT01641796

Brief Summary

This is an expanded access treatment protocol designed to provide a topical cream treatment option to military health care beneficiaries with parasitologically confirmed uncomplicated Cutaneous Leishmaniasis.

Trial Health

55
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Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2012

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

First QC Date

June 18, 2012

Last Update Submit

May 13, 2020

Conditions

Leishmaniasis, Cutaneous

Keywords

Cutaneous LeishmaniasisCLLesionTopicalTreatmentCreamExpanded Access

Interventions

ParomomycinDRUG

Paromomycin Topical Cream applied to all lesions once a day for 20 days

Also known as: Paromomycin Topical Cream

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female military health care beneficiary of any age.
  • Diagnosis of uncomplicated CL by having at least one lesion parasitologically confirmed by at least one of the following methods: 1) positive culture for promastigotes; 2) microscopic identification of amastigotes in stained lesion tissue; and/or 3) PCR assay performed either at the LDL, WRAIR or the Clinical Parasitology Service, CDC.
  • Ability to comprehend and willingness to sign informed consent or give assent
  • CL lesions in a location amenable to topical treatment
  • Patient is willing to forgo other treatments for CL while on treatment program
  • Females of childbearing potential must have a negative pregnancy test within 1 day of starting treatment and agree to use an acceptable method of birth control from start of treatment until 2 weeks after completing treatment

You may not qualify if:

  • Clinically significant concomitant disease that would preclude the patient from completing treatment in the opinion of the treating physician.
  • Clinical Evidence of mucosal involvement
  • Known allergy to aminoglycosides
  • Females who are pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

Military Treatment Facilities

Multiple Locations, Maryland, 20814, United States

Location

Related Publications (1)

  • Grogl M, Schuster BG, Ellis WY, Berman JD. Successful topical treatment of murine cutaneous leishmaniasis with a combination of paromomycin (Aminosidine) and gentamicin. J Parasitol. 1999 Apr;85(2):354-9.

    PMID: 10219319BACKGROUND

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

Paromomycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Naomi Aronson, MD

    Uniformed Services University of the Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2012

First Posted

July 17, 2012

Last Updated

May 15, 2020

Record last verified: 2020-05

Locations

US(2)