Phase 2
N=92
Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World
Cutaneous Leishmaniasis
Bottom Line
View on ClinicalTrials.gov: NCT00703924 ↗Enrolled (actual)
92
Serious AEs
1.1%
Results posted
Feb 2017
Primary outcome: Primary: Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days) — 47; 30; 3; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- WR 279,396 (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Nov 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days) |
47; 30; 3; 12 | — |
| PRIMARY Safety of WR 279,396 (AEs and SAEs) |
49; 40; 11; 5; 2; 2 | — |
| SECONDARY Time to Complete Re-epithelialization of the Index Lesion Ulcer Without Relapse |
10; 34; 4; 1; 20; 10 | — |
| SECONDARY Final Cure Rate by Subject of All Lesions |
46; 29; 4; 13 | — |
| SECONDARY Rate of Relapse |
0; 3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00703924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.