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Trial record 1 of 1 for:    NCT00703924
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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 (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00703924
First received: June 20, 2008
Last updated: April 25, 2017
Last verified: April 2017
June 20, 2008
April 25, 2017
March 2003
November 2004   (Final data collection date for primary outcome measure)
  • Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days) [ Time Frame: 180 days ]
    CCR is defined as at least 50% reduction, from baseline, in index lesion area of ulceration at study days 50, 100 and 180 (+ 7 days). Randomized subjects were compared using the uncorrected Fisher's exact test. Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable. The Breslow-Day test was used to examine whether the effect of WR 279,396 varied between subgroups
  • Safety of WR 279,396 (AEs and SAEs) [ Time Frame: 180 days ]
    Safety was evaluated on each day during daily administration of the topical products. Subjects were observed and questioned for the occurrence of solicited local side effects (eg, pain, erythema, edema) and solicited systemic side effects (eg, vertigo, tinnitus, diminished hearing). Non-solicited AE evaluations included spontaneous reports from subjects and clinical observations.
Re-epithelialization of lesion [ Time Frame: 50 days ]
Complete list of historical versions of study NCT00703924 on ClinicalTrials.gov Archive Site
  • Time to Complete Re-epithelialization of the Index Lesion Ulcer Without Relapse [ Time Frame: 180 days ]
    100% re-epithelialization of the index lesion without having had a relapse. The log-rank test was used to compare the time to complete re-epithelialization.
  • Final Cure Rate by Subject of All Lesions [ Time Frame: 180 days ]
    Final cure rate by subject was determined using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable.
  • Rate of Relapse [ Time Frame: 180 days ]

    Relapse is defined as enlargement of the index lesion compared to previous measurement at any time after day 50 (+ 7 days) or not demonstrating CCR by study day 180. CCR was compared using uncorrected Fisher's exact test.

    Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable.

Safety and tolerance of the cream [ Time Frame: 50 days ]
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
This study is to determine the effectiveness and safety 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. Subjects will be randomized to receive either WR 279,396 or vehicle placebo; applied twice a day for 20 days.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Cutaneous Leishmaniasis
  • Drug: WR 279,396
    A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion
    Other Name: Paromomycin topical cream
  • Drug: Placebo
    Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion
    Other Name: Topical vehicle placebo
  • Experimental: WR 279,396
    WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin
    Intervention: Drug: WR 279,396
  • Placebo Comparator: Placebo
    Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.
    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. doi: 10.1371/journal.pntd.0000432. 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
92
November 2005
November 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:
  • Hearing abnormality
  • Ongoing pregnancy or have plans to become pregnant
  • Females of child bearing age (Tunisia Only)
  • Signs or symptoms of peripheral neuropathy

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

Sexes Eligible for Study: All
5 Years to 75 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Tunisia
 
 
NCT00703924
A-9768.1
IND 50098 ( Other Identifier: FDA )
No
Not Provided
Yes
Data will be shared with WRAIR
U.S. Army Medical Research and Materiel Command
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
April 2017

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