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Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World

This study has been completed.
Sponsor:
Collaborator:
Walter Reed Army Institute of Research (WRAIR)
Information provided by:
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00703924
First received: June 20, 2008
Last updated: March 15, 2012
Last verified: March 2012
History of Changes

June 20, 2008
March 15, 2012
March 2003
October 2004   (final data collection date for primary outcome measure)
Re-epithelialization of lesion [ Time Frame: 50 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00703924 on ClinicalTrials.gov Archive Site
Safety and tolerance of the cream [ Time Frame: 50 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World
Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: a Phase 2 Study in the Old World

The objective of this study is to determine the effectiveness and toxicity of WR 279,396, a topical cream for the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo control under double-blind conditions in a local population group in Tunisia where leishmaniasis is endemic.

WR 279,396 is a paromomycin-based topical cream that has shown some suggestion of being effective for the treatment of non-serious, non-complicated cutaneous leishmaniasis in previous clinical studies. The goal of this study is to expand those observations in a larger, more rigorous study to clearly define the efficacy of this product and collect information about adverse effects.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Cutaneous Leishmaniasis
  • Drug: WR 279,396
    A topical cream containing 15% paromomycin
    Other Name: Paromomycin topical cream
  • Drug: Placebo
    Topical cream vehicle
    Other Name: Topical vehicle placebo
  • Experimental: 1
    WR 279,396 is a topical antibiotic cream containing paromomycin
    Intervention: Drug: WR 279,396
  • Placebo Comparator: 2
    Topical cream vehicle
    Intervention: Drug: Placebo
Ben Salah A, Buffet PA, Morizot G, Ben Massoud N, Zâatour A, Ben Alaya N, Haj Hamida NB, El Ahmadi Z, Downs MT, Smith PL, Dellagi K, Grögl M. WR279,396, a third generation aminoglycoside ointment for the treatment of Leishmania major cutaneous leishmaniasis: a phase 2, randomized, double blind, placebo controlled study. PLoS Negl Trop Dis. 2009;3(5):e432. Epub 2009 May 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2004
October 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 5-75 years
  • Lesions must measure at least 1 cm and be primarily ulcerative
  • Have cutaneous leishmaniasis proven parasitologically in the lesion selected for study
  • Must have given written informed consent to participate in the study

Exclusion Criteria:

  • Known drug intolerance to aminoglycosides in the patient or immediate family
  • Previous use of antileishmanial drugs (within 3 months) or present use of routinely nephrotoxic or ototoxic drugs
  • Patients with tuberculosis under treatment
  • Potential for follow-up: have less than 7 months time remaining in present address and/or plan to leave the area for more than 30 days
  • Extent of disease: more than 5 lesions or lesion equal to or greater than 5 cm or a lesion less than 5 cm from the eye, or a lesion in the face that, in the opinion of the attending dermatologist could potentially cause significant disfigurement
  • Location of disease: mucosal involvement
  • Disseminated disease: clinically significant lymphadenitis with nodules that are painful and greater than 1 cm in size in the lymphatic drainage of the ulcer
  • Concomitant medical problems: significant medical problems of the kidney or liver as determined by history and by the following laboratory studies:

Kidney: clinically significant abnormalities of urine analysis, serum levels of creatinine, BUN, total proteins greater than the upper limit of normal for the laboratory.

Liver: AST or ALT greater than the upper limit of normal for the laboratory General: glucose, Na+, or K+ greater than the upper limit of normal for the laboratory
Both
5 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00703924
A-9768
No
Robert E. Miller, Ph.D., RAC, Director, Division of Regulated Activities and Compliance, USAMMDA
U.S. Army Medical Research and Materiel Command
Walter Reed Army Institute of Research (WRAIR)
Principal Investigator: Afif Ben Salah, M.D., Ph.D. Institute Pasteur Tunisia
U.S. Army Medical Research and Materiel Command
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP