Phase 3
N=399
Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama
Cutaneous Leishmaniasis
Bottom Line
View on ClinicalTrials.gov: NCT01790659 ↗Enrolled (actual)
399
Serious AEs
0.8%
Results posted
Aug 2017
Primary outcome: Primary: Percent of Participants With Final Clinical Cure — 78.6; 77.8 percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- WR 279,396 (Drug); Paromomycin (Drug)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With Final Clinical Cure |
78.6; 77.8 | — |
| SECONDARY Percentage of Subjects With All Lesions Cured |
75.1; 76.3 | — |
| SECONDARY Percentage of All Lesions Cured at Day 168 (Ignores Per Subject Cure Rate) |
77.2; 83.3 | — |
| SECONDARY Area of Ulceration (mm^2) of the Index Lesion at Each Measurement Time Point |
153; 165; 831; 928; 677; 762 | — |
| SECONDARY Area of Ulceration (mm^2) All Treated Lesions at Each Measurement Time Point |
115; 115; 656; 699; 533; 577 | — |
| SECONDARY Median Time to Initial Clinical Cure for Index Lesions |
36.000; 48.000 | — |
Summary
This study is a pivotal Phase 3, randomized, double-blind, 3-site, two-group trial assessing the efficacy and safety of WR 279,396 Topical Cream and Paromomycin Alone Topical Cream in subjects with CL in Panama. The primary objective of this study is to determine if WR 279,396 results in statistically superior final clinical cure rates of an index lesion when compared with Paromomycin Alone for the treatment of CL in Panama expected to be caused by L panamensis.
Eligibility Criteria
Inclusion Criteria
- Male or female at least 2 years-of-age
- Subject or legal guardian able to give written informed consent or assent, as appropriate
- Diagnosis of CL in at least one lesion by at least one of the following methods: 1) positive culture for promastigotes or 2) microscopic identification of amastigotes in stained lesion tissue
- At least one ulcerative lesion ≥ 1 cm and ≤ 5 cm that has a diagnosis of CL
- Willing to forego other forms of treatments for CL including other investigational treatments during the study
- In the opinion of the investigator, subject (or their legal guardian), subject is capable of understanding and complying with the protocol
- If female and of child-bearing potential, must have a negative serum pregnancy test during screening and agree to use an acceptable method of birth control during the treatment phase and for 1 week after treatment is completed
Exclusion Criteria
- Lesion due to leishmania that involves the nasal or oral mucosa or any signs of mucosal disease that might be due to Leishmania
- Only a single lesion on the ear with erosive cartilage
- Signs and symptoms of disseminated disease in the opinion of the investigator
- More than 10 lesions
- Female who is breast-feeding
- Significant organ abnormality, chronic disease such as diabetes, severe hearing loss, evidence of renal or hepatic dysfunction, or creatinine, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) greater than 15% above the upper limit of normal (ULN) as defined by the clinical laboratory defined normal ranges
- Received treatment for leishmaniasis including any medication with pentavalent antimony including sodium stibogluconate (Pentostam™), meglumine antimoniate (Glucantime™); amphotericin B (including liposomal amphotericin B and amphotericin B deoxycholate); or other medications containing paromomycin (administered parenterally or topically) or methylbenzethonium chloride (MBCL); gentamicin; fluconazole; ketoconazole; pentamidine; miltefosine, azithromycin or allopurinol that was completed within 56 days of starting study treatments
- History of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides
Data sourced from ClinicalTrials.gov (NCT01790659). 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.