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

United States Army Medical Research and Development Command (USAMRDC)

Status and phase

Completed

Phase 2

Conditions

Cutaneous Leishmaniasis

Treatments

Drug: WR 279,396

Drug: Placebo

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00703924

IND 50098 (Other Identifier)

A-9768.1

Details and patient eligibility

About

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.

Full 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.

Enrollment

92 patients

Sex

All

Ages

5 to 75 years old

Volunteers

No Healthy Volunteers

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