Status:
COMPLETED
Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
Walter Reed Army Institute of Research (WRAIR)
Conditions:
Cutaneous Leishmaniasis
Eligibility:
All Genders
5-75 years
Phase:
PHASE2
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-b...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00703924
Start Date
March 1 2003
End Date
November 1 2005
Last Update
May 30 2017
Active Locations (2)
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1
Medical Center Institut Pasteur
Paris, France, 75015
2
Institue Pasteur
Tunis, Tunisia