NCT00703924

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2003

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2008

Completed
8.7 years until next milestone

Results Posted

Study results publicly available

February 15, 2017

Completed
Last Updated

May 30, 2017

Status Verified

April 1, 2017

Enrollment Period

1.7 years

First QC Date

June 20, 2008

Results QC Date

December 21, 2016

Last Update Submit

April 25, 2017

Conditions

Cutaneous Leishmaniasis

Keywords

cutaneous leishmaniasis topical treatment safety efficacy

Outcome Measures

Primary Outcomes (2)

  • Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 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

    180 days

  • Safety of WR 279,396 (AEs and SAEs)

    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.

    180 days

Secondary Outcomes (3)

  • Time to Complete Re-epithelialization of the Index Lesion Ulcer Without Relapse

    180 days

  • Final Cure Rate by Subject of All Lesions

    180 days

  • Rate of Relapse

    180 days

Study Arms (2)

WR 279,396

EXPERIMENTAL

WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin

Drug: WR 279,396

Placebo

PLACEBO COMPARATOR

Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.

Drug: Placebo

Interventions

WR 279,396DRUG

A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion

Also known as: Paromomycin topical cream
WR 279,396
PlaceboDRUG

Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion

Also known as: Topical vehicle placebo
Placebo

Eligibility Criteria

Age5 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical Center Institut Pasteur

Paris, 75015, France

Location

Institue Pasteur

Tunis, Tunisia

Location

Related Publications (1)

  • Ben Salah A, Buffet PA, Morizot G, Ben Massoud N, Zaatour A, Ben Alaya N, Haj Hamida NB, El Ahmadi Z, Downs MT, Smith PL, Dellagi K, Grogl 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.

    PMID: 19415122RESULT

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Afif Ben Salah, MD, PhD
Organization
Institute Pasteur Tunisia
afif.bensalah@pasteur.rns.tn
216-71-792-429

Study Officials

  • Afif Ben Salah, M.D., Ph.D.

    Institute Pasteur Tunisia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2008

First Posted

June 24, 2008

Study Start

March 1, 2003

Primary Completion

November 1, 2004

Study Completion

November 1, 2005

Last Updated

May 30, 2017

Results First Posted

February 15, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Data will be shared with WRAIR

Locations

FR(1)TU(1)