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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.
 
ClinicalTrials.gov Identifier: NCT00657917
Recruitment Status : Terminated (No subjects were enrolled since the first subject completed the study 08Jun2007)
First Posted : April 14, 2008
Results First Posted : January 22, 2019
Last Update Posted : January 22, 2019
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
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
Actual Study Start Date : December 20, 2006
Actual Primary Completion Date : June 8, 2007
Actual Study Completion Date : June 24, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Paromomycin +Gentamicin topical cream
WR279,396 topically twice a day for 20 days
 Drug: Paromomycin +Gentamicin topical cream
WR297,396 for treatment of patients with parasitologically confirmed, primarily ulcerative, Old World CL, who had either failed pentavalent antimony treatment, or who where ineligible for pentavalent antimony therapy.
Other Name: WR279,396


Outcome Measures
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Primary Outcome Measures :
  1. The Appearance of Complete Epithelialization of Ulcerative Lesions Caused by Old World Cutaneous Leishmaniasis With no Relapse [ Time Frame: 180 days ]
    Appearance of complete (100%) epithelialization of a skin lesion at day 50+2 weeks, or the estimated 50%-99% re-epithelialization by day 50+2 weeks followed by complete eipithelialization by day 100+2 weeks, with both categories without relapse by day 180+30 days. Ulcer measured in millimeters.


Secondary Outcome Measures :
  1. Number of Relapses [ Time Frame: 180 days ]
    Evaluate the number of relapses occurring by day 180

  2. Safety and Tolerability (SAE's and AE's) [ Time Frame: 180 days ]
    Evaluate safety and tolerability as measured by completion of a full prescribed treatment course, treatment interruptions, SAE's and AE's


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00657917


Locations
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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 Development Command
Walter Reed Army Medical Center
Investigators
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Principal Investigator: COL Naomi Aronson, M.D. Uniformed Services Univ of the Health Sciences
More Information
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Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT00657917    
Other Study ID Numbers: A-13225
First Posted: April 14, 2008    Key Record Dates
Results First Posted: January 22, 2019
Last Update Posted: January 22, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by U.S. Army Medical Research and Development Command:
leishmaniasis
cutaneous
Old World
Leishmania major
Treatment
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Infections
Skin Diseases, Parasitic
Vector Borne Diseases
Skin Diseases, Infectious
Skin Diseases
 Gentamicins
Paromomycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiprotozoal Agents
Antiparasitic Agents