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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657917
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : December 1, 2011
Walter Reed Army Medical Center
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cutaneous Leishmaniasis Drug: Paromomycin +Gentamicin topical cream Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396
Study Start Date : November 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
U.S. FDA Resources

Intervention Details:
    Drug: Paromomycin +Gentamicin topical cream
    Apply topically twice daily for 20 days
    Other Name: WR279,396

Primary Outcome Measures :
  1. The primary outcome is the re-epithelialization of ulcerative lesions caused by Old World cutaneous leishmaniasis with no relapse [ Time Frame: 180 days ]

Secondary Outcome Measures :
  1. the secondary outcome is to determine if there are any local or systemic signs of toxicity, and if so to grade them. [ Time Frame: 180 days ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 lesion
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00657917

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Walter Reed Army Medical Center
Principal Investigator: COL Naomi Aronson, M.D. Uniformed Services Univ of the Health Sciences

Responsible Party: U.S. Army Medical Research and Materiel Command Identifier: NCT00657917     History of Changes
Other Study ID Numbers: A-13225
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: December 1, 2011
Last Verified: November 2011

Keywords provided by U.S. Army Medical Research and Materiel Command:
Old World
Leishmania major

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