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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00703924
• Date of registration: 20/06/2008
• Prospective Registration: No
• Primary sponsor: U.S. Army Medical Research and Materiel Command
• Public title: Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World
• Scientific title: Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: a Phase 2 Study in the Old World
• Date of first enrolment: March 2003
• Target sample size: 92
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00703924
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

France, Tunisia

Contacts

• Name: Afif Ben Salah, M.D., Ph.D.
• Affiliation: Institute Pasteur Tunisia

Key inclusion & exclusion 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



Age minimum: 5 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cutaneous Leishmaniasis

Intervention(s)

Drug: Placebo

Drug: WR 279,396

Primary Outcome(s)

Safety of WR 279,396 (AEs and SAEs) [Time Frame: 180 days]

Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days) [Time Frame: 180 days]

Secondary Outcome(s)

Final Cure Rate by Subject of All Lesions [Time Frame: 180 days]

Rate of Relapse [Time Frame: 180 days]

Time to Complete Re-epithelialization of the Index Lesion Ulcer Without Relapse [Time Frame: 180 days]

Secondary ID(s)

IND 50098

A-9768.1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Walter Reed Army Institute of Research (WRAIR)

Results

• Results available: Yes
• Date Posted: 15/02/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00703924