Phase 3
N=375
Phase 3 Study to Evaluate WR 279,396 vs. Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)
Cutaneous Leishmaniasis
Bottom Line
View on ClinicalTrials.gov: NCT00606580 ↗Enrolled (actual)
375
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Final Clinical Cure Rate — 101; 102; 73 participants — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- WR 279,396 topical cream (Drug); Paromomycin Alone topical cream (Drug); Vehicle placebo cream (Drug)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Final Clinical Cure Rate |
101; 102; 73 | 0.0001 sig |
| SECONDARY Final Clinical Cure Rate (Per Protocol Dataset) |
101; 102; 73 | 0.0006 sig |
| SECONDARY Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse |
67.2; 68.8; 48.8 | 0.330 |
| SECONDARY Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up |
67.2; 68.5; 49.4; 72.9; 81.5; 57.1 | — |
| SECONDARY Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 42 |
51.7; 81.6; 58.1 | — |
| SECONDARY Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 49 |
81.4; 90.4; 64.9 | — |
| SECONDARY Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 98 |
91.5; 98.9; 92.2 | — |
| SECONDARY Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion |
105; 107; 77 | 0.0001 sig |
| SECONDARY Number of Subjects Achieving Re-epithelialization of the Index Lesion Without Relapse |
84; 84; 62 | 0.005 sig |
| SECONDARY Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions Without Subsequent Relapse |
83; 84; 60 | 0.003 sig |
| SECONDARY Number of All Ulcerated Lesions Achieving 100% Re-epithelialization by Day 42 |
190; 218; 160 | <0.001 sig |
| SECONDARY Number of Subjects With a Relapse on or After Day 42 |
4; 3; 2 | 0.409 |
Summary
This study will test the ability of the topical cream WR 279,396 to treat the skin lesions caused by the parasite called leishmania. WR 279,396 is an antibiotic preparation that contains paromomycin + gentamicin. This cream will be compared to the effect of a topical cream containing paromomycin alone and to a placebo cream that contains no antibiotics. Therefore, this study will have three groups of patients, and they will be assigned to one of these treatments randomly. The study will be carried out without the patient or the physician knowing which cream is being used for which patient. The goal is to determine if WR 279,396 cream or the paromomycin cream is better than placebo, and if WR 279,396 is better than paromomycin alone.
Eligibility Criteria
Inclusion Criteria
- The subject was age 5 years or older, but less than 65 years.
- The subject was able to understand the information provided to him/her and give written informed consent. Consent was obtained from the parent/guardian of subjects who were 1 cm in the lymphatic drainage of the ulcer.
- The subject was a female with a positive urine pregnancy test, or who was breast feeding or lactating.
- The subject had an active malignancy or had a history of a solid, metastatic or hematologic malignancy, with the exception of a basal or squamous cell carcinoma of the skin that had been removed.
- The subject had a significant organ abnormality or chronic disease that, in the opinion of the investigator, would warrant exclusion of the subject from the study or would prevent the subject from completing the study.
- The subject was receiving any of the following medications: any medication containing pentavalent antimony, including stibogluconate sodium (Pentostam®) and meglumine antimoniate (Glucantime®); amphotericin B, including liposomal amphotericin B and amphotericin B deoxycholate; other medications containing paromomycin (administered IV or topically); methylbenzethonium chloride, fluconazole, ketoconazole, itraconazole; pentamidine; or allopurinol.
- The subject or the subject's parent/guardian was unable to understand verbal and/or written Arabic, English, or French (languages in which certified translations of the informed consent were available).
- The subject presented with an immuno-compromising condition, including recidivant leishmaniasis (during the past 2 years), or diabetes.
- The subject had a history of known or suspected idiosyncratic reactions or hypersensitivity to aminoglycosides.
Data sourced from ClinicalTrials.gov (NCT00606580). 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.