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WR 279,396 and Paromomycin for Cutaneous Leishmaniasis
NCT00606580Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2008
- Primary completion
- Jul 2011
- Countries
- 1
- Sponsor
- U.S. Army Medical Research and Development Command
- Modality
- Nanoparticles, Implantable Devices, Transdermal Patches
- Conditions
- cutaneous leishmaniasis (CL)
01
Overview
Phase 3, randomised, double-blind trial of paromomycin and gentamicin in cutaneous leishmaniasis (CL) (3 arms), sponsored by U.S. Army Medical Research and Development Command. Primary endpoint: Final Clinical Cure Rate at Day 168. Started Jan 2008; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
WR 279,396
15% paromomycin + 0.5% gentamicin topical cream
Paromomycin Alone
15% paromomycin topical cream
Vehicle Placebo
Cream base without antibiotics
03
Who it enrols
Patients aged 5-65 with 1-5 uncomplicated cutaneous leishmaniasis lesions (index lesion 1-5 cm, ulcerative), excluding those with mucosal/disseminated disease, pregnancy, diabetes, or recent anti-leishmanial treatment.
04
Endpoints
Primary
Final Clinical Cure Rate
Secondary
Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse
Number of Subjects With a Relapse on or After Day 42
Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion
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