Overview

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

Status:
Completed
Trial end date:
2005-11-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
U.S. Army Medical Research and Development Command
U.S. Army Medical Research and Materiel Command
Collaborator:
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