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Expanded Access WR 279396 Topical Cream Treatment for Uncomplicated Cutaneous Leishmaniasis (WR279396RX)

Expanded access is temporarily not available for this treatment.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01641796
First received: June 18, 2012
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Leishmaniasis, Cutaneous
 Drug: WR 279,396

Study Type: Expanded Access     What is Expanded Access?
Official Title: WR 279,396 (Paromomycin + Gentamicin Topical Cream) Treatment Program for Individuals With Uncomplicated Cutaneous Leishmaniasis

Resource links provided by NLM:

MedlinePlus related topics: Leishmaniasis
U.S. FDA Resources

Further study details as provided by U.S. Army Medical Research and Materiel Command:

Intervention Details:
    Drug: WR 279,396
    Topical Cream applied to lesion once a day
    Other Name: Topical paromomycin and gentamicin combination cream.
Detailed Description:

When a military health care beneficiary presents at a Department of Defense Military Treatment Facility with a skin lesion clinically and epidemiologically consistent with suspicious Cutaneous Leishmaniasis, routine diagnostic parasitology testing will be performed as standard of care, and if there is a positive diagnosis, the patient will be offered the option to participate in this treatment program and after providing written informed consent/assent., if eligible to participate, the patient will receive treatment with WR 279,396.

  Eligibility

Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641796

Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Naomi Aronson, MD Uniformed Services University of the Health Sciences
  More Information

Publications:

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01641796     History of Changes
Other Study ID Numbers: S-12-13, S-12-13
Study First Received: June 18, 2012
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
Cutaneous Leishmaniasis
CL
Lesion
Topical
 Treatment
Cream
Expanded Access

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Gentamicins
Paromomycin
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Amebicides
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 21, 2013