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

Cutaneous Leishmaniasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703924
• Other study ID #: A-9768.1
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2008
• Last updated: June 5, 2015
• Start date: March 2003
• Est. completion date: January 2005

Study information

• Verified date: June 2015
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: January 2005
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

Drug:
• WR 279,396
A topical cream containing 15% paromomycin
• Placebo
Topical cream vehicle

Locations

Country	Name	City	State
France	Medical Center Institut Pasteur	Paris
Tunisia	Institue Pasteur	Tunis

Sponsors (2)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command	Walter Reed Army Institute of Research (WRAIR)

Countries where clinical trial is conducted

France,  Tunisia, 

References & Publications (1)

Ben Salah A, Buffet PA, Morizot G, Ben Massoud N, Zâatour A, Ben Alaya N, Haj Hamida NB, El Ahmadi Z, Downs MT, Smith PL, Dellagi K, Grögl M. WR279,396, a third generation aminoglycoside ointment for the treatment of Leishmania major cutaneous leishmanias — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-epithelialization of lesion		50 days	No
Secondary	Safety and tolerance of the cream		50 days	Yes