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Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396

Information source: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cutaneous Leishmaniasis

Intervention: Paromomycin +Gentamicin topical cream (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: U.S. Army Medical Research and Materiel Command

Official(s) and/or principal investigator(s):
COL Naomi Aronson, M.D., Principal Investigator, Affiliation: Uniformed Services Univ of the Health Sciences


The primary objective of this protocol is to treat laboratory confirmed cutaneous leishmaniasis with WR 279,396 in military health care beneficiaries. In this study "cutaneous leishmaniasis" is defined as Old World Leishmaniasis if acquired in the Southwest Central Asia/Middle East.

Clinical Details

Official title: Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary outcome is the re-epithelialization of ulcerative lesions caused by Old World cutaneous leishmaniasis with no relapse

Secondary outcome: the secondary outcome is to determine if there are any local or systemic signs of toxicity, and if so to grade them.

Detailed description: Up to 10 volunteers, who are military health care beneficiaries, with a diagnosis of Old World cutaneous leishmaniasis who have failed pentavalent antimony or are not eligible to be treated with pentavalent antimony, will be treated with WR 279,396 (topical paromomycin-gentamicin-AQIC) twice a day for 20 days. Primary endpoint will be the appearance of complete epithelialization of each skin lesion by Day 50+/-2 weeks, or estimated 50%-99% re-epithelialization by Day 50+/-2 weeks followed by complete epithelialization by Day 100+/-2 weeks,with both categories without relapse by Day 180+/-30 days. Efficacy will be evaluated by clinical appearance assessed by study investigator and documented with photographs of the treated skin lesions. Toxicity will be evaluated by local adverse reactions and by laboratory signs of systemic toxicity.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria: Parasitologically confirmed, primarily ulcerative, Old World CL, in a patient who had either failed pentavalent antimony treatment, or who was ineligible for pentavalent antimony therapy.

- Military health care beneficiary 18 years of age or greater, unless active military

in which case, 17 years is the minimum age

- Proven parasitological diagnosis by culture, PCR or microscopy in at least one skin


- Lesions primarily ulcerative (i. e., not verrucous or nodular)

- Written informed consent to participate in protocol

- Negative pregnancy test within 72 hours of starting protocol

- Agrees to take precautions not to become pregnant or father a child for at least two

months after completion of treatment with WR 279,396

- Cutaneous leishmaniasis acquired in Southwest Central Asia/Middle East*

- Inadequate response to treatment with pentavalent antimony or medical condition that

precludes the use of pentavalent antimony Exclusion Criteria:

- Drug intolerance: history of known or suspected hypersensitivity or idiosyncratic

reactions to aminoglycosides in the patient

- any leishmanial lesion on mucosal surface

- Presence of signs or symptoms of peripheral neuropathic myasthenia gravis,

neuromuscular block

- Routinely taking nephrotoxic or ototoxic medications

- Disseminated disease defined as clinically significant subcutaneous nodules that are

in the lymphatic drainage tract for the skin lesion with regional adenopathy > 1 cm

- Abnormal Romberg test at baseline

- Clinically significant medical problems of the kidney or liver as determined by

history and by the following laboratory studies:

- Kidney: Creatinine > 2x the upper limit of normal

- Liver: ASTor ALT >4x the upper limit fo normal

- This includes "L. major," "L. tropica," and "L. infantum" with over 98% of

cases in U. S. military in 2002-2004 being "L. major"

- An inadequate response to treatment with pentavalent antimony includes

patients who show no or little improvement during a 15-20 day treatment course, those that initially epithelialize but later show signs of breakdown/ ulceration or develop new lesions. In general, for those with initial treatment response, would recommend waiting for approximately two months after pentavalent antimony and if lesion is not epithelialized at that time, consideration for further therapy is advised.

Locations and Contacts

Walter Reed Army Medical Center, Washington, District of Columbia 20307, United States
Additional Information

Starting date: November 2004
Last updated: November 29, 2011

Page last updated: August 23, 2015

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