Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command Identifier:
First received: June 20, 2008
Last updated: December 21, 2016
Last verified: December 2016
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.

Condition Intervention Phase
Cutaneous Leishmaniasis
Drug: WR 279,396
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: a Phase 2 Study in the Old World

Resource links provided by NLM:

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

Primary Outcome Measures:
  • 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.

  • Efficacy and 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.

Secondary Outcome Measures:
  • 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

  • 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

Enrollment: 92
Study Start Date: March 2003
Study Completion Date: November 2005
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WR 279,396
WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin
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
Placebo Comparator: Placebo
Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.
Drug: Placebo
Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion
Other Name: Topical vehicle placebo

Detailed Description:
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.

Ages Eligible for Study:   5 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  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 identifier: NCT00703924

Medical Center Institut Pasteur
Paris, France, 75015
Institue Pasteur
Tunis, Tunisia
Sponsors and Collaborators
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
  More Information

Responsible Party: U.S. Army Medical Research and Materiel Command Identifier: NCT00703924     History of Changes
Other Study ID Numbers: A-9768.1
IND 50098 ( Other Identifier: FDA )
Study First Received: June 20, 2008
Results First Received: December 21, 2016
Last Updated: December 21, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Data will be shared with WRAIR

Keywords provided by U.S. Army Medical Research and Materiel Command:
cutaneous leishmaniasis topical treatment safety efficacy

Additional relevant MeSH terms:
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents processed this record on May 25, 2017