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

Sponsors and Collaborators:	U.S. Army Medical Research and Materiel Command Walter Reed Army Institute of Research (WRAIR)
Information provided by:	U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:	NCT00703924

Purpose

The objective of this study is to determine the effectiveness and toxicity 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.

Condition	Intervention	Phase
Cutaneous Leishmaniasis	Drug: WR 279,396 Drug: Placebo	Phase II

MedlinePlus related topics: Leishmaniasis

Drug Information available for: Paromomycin Paromomycin sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: a Phase 2 Study in the Old World

Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:

Re-epithelialization of lesion [ Time Frame: 50 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerance of the cream [ Time Frame: 50 days ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	March 2003
Study Completion Date:	October 2004
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental WR 279,396 is a topical antibiotic cream containing paromomycin	Drug: WR 279,396 A topical cream containing 15% paromomycin
2: Placebo Comparator Topical cream vehicle	Drug: Placebo Topical cream vehicle

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.

Eligibility

Ages Eligible for Study:	5 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703924

Sponsors and Collaborators

U.S. Army Medical Research and Materiel Command

Walter Reed Army Institute of Research (WRAIR)

Investigators

Principal Investigator:

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

Institute Pasteur Tunisia

More Information

Responsible Party:	Division of Regulated Activities and Compliance, USAMMDA ( Robert E. Miller, Ph.D., RAC, Director )
Study ID Numbers:	A-9768
Study First Received:	June 20, 2008
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00703924
Health Authority:	United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:

cutaneous leishmaniasis topical treatment safety efficacy

Study placed in the following topic categories:

Leishmaniasis
Protozoan Infections
Skin Diseases, Infectious
Skin Diseases

Parasitic Diseases
Leishmaniasis, Cutaneous
Paromomycin

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Skin Diseases, Parasitic

Therapeutic Uses
Sarcomastigophora Infections
Mastigophora Infections
Amebicides
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009