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

NCT ID: NCT00703924

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2005-11-30

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-blind conditions in a local population group in Tunisia where leishmaniasis is endemic.

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. 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.

Conditions

Cutaneous Leishmaniasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

WR 279,396

WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin

Group Type: EXPERIMENTAL

WR 279,396

Intervention Type: DRUG

A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion

Placebo

Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion

Interventions

WR 279,396

A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion

Intervention Type: DRUG

Placebo

Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion

Intervention Type: DRUG

Other Intervention Names

Paromomycin topical cream; Topical vehicle placebo

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed Army Institute of Research (WRAIR)

FED

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Afif Ben Salah, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Institute Pasteur Tunisia

Locations

Medical Center Institut Pasteur

Paris, , France

Institue Pasteur

Tunis, , Tunisia

Countries

France; Tunisia

References

Ben Salah A, Buffet PA, Morizot G, Ben Massoud N, Zaatour A, Ben Alaya N, Haj Hamida NB, El Ahmadi Z, Downs MT, Smith PL, Dellagi K, Grogl M. WR279,396, a third generation aminoglycoside ointment for the treatment of Leishmania major cutaneous leishmaniasis: a phase 2, randomized, double blind, placebo controlled study. PLoS Negl Trop Dis. 2009;3(5):e432. doi: 10.1371/journal.pntd.0000432. Epub 2009 May 5.

Reference Type: RESULT

PMID: 19415122 (View on PubMed)

Other Identifiers

IND 50098

Identifier Type: OTHER

Identifier Source: secondary_id

A-9768.1

Identifier Type: -

Identifier Source: org_study_id