Overview
Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World
Status:
Completed
Completed
Trial end date:
2005-11-01
2005-11-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
U.S. Army Medical Research and Development Command
U.S. Army Medical Research and Materiel CommandCollaborator:
Walter Reed Army Institute of Research (WRAIR)Treatments:
Paromomycin
Criteria
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