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

This study has been completed.
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00657917
First received: February 22, 2008
Last updated: November 29, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Cutaneous Leishmaniasis
Drug: Paromomycin +Gentamicin topical cream
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The primary outcome is the re-epithelialization of ulcerative lesions caused by Old World cutaneous leishmaniasis with no relapse [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: November 2004
Study Completion Date: November 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Paromomycin +Gentamicin topical cream
    Apply topically twice daily for 20 days
    Other Name: WR279,396
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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 ClinicalTrials.gov identifier: NCT00657917

Locations
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
Investigators
Principal Investigator: COL Naomi Aronson, M.D. Uniformed Services Univ of the Health Sciences
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00657917     History of Changes
Other Study ID Numbers: A-13225
Study First Received: February 22, 2008
Last Updated: November 29, 2011
Health Authority: United States: Food and Drug Administration

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

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 July 24, 2014