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