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

Expanded access is currently available for this treatment.
Verified August 2016 by U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command Identifier:
First received: June 18, 2012
Last updated: August 25, 2016
Last verified: August 2016
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 Protocol for Individuals With Uncomplicated Cutaneous Leishmaniasis

Resource links provided by NLM:

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.

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   All

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01641796

Contact: Naomi Aronson, MD 301-295-3621
Contact: Timothy Whitman, DO 301-295-6400

United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
Contact: Naomi Aronson, MD    301-295-3621   
Contact: Peter J Weina, MD    301-400-1239   
Military Treatment Facilities
Multiple, Maryland, United States, 20814
Contact: Naomi Aronson, MD   
Principal Investigator: Naomi Aronson, MD         
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Principal Investigator: Naomi Aronson, MD Uniformed Services University of the Health Sciences
  More Information

Responsible Party: U.S. Army Medical Research and Materiel Command Identifier: NCT01641796     History of Changes
Other Study ID Numbers: S-12-13  S-12-13/M-10337 
Study First Received: June 18, 2012
Last Updated: August 25, 2016
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board

Keywords provided by U.S. Army Medical Research and Materiel Command:
Cutaneous Leishmaniasis
Expanded Access

Additional relevant MeSH terms:
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on January 14, 2017