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A Randomized, Double-blind, Pivotal Phase 3 Study of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Alone Topical Cream for the Treatment of Cutaneous Leishmaniasis in Panama
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.
Details
| Lead sponsor | U.S. Army Medical Research and Development Command |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 399 |
| Start date | 2013-05 |
| Completion | 2016-01 |
Conditions
- Cutaneous Leishmaniasis
Interventions
- WR 279,396
- Paromomycin
Primary outcomes
- Percent of Participants With Final Clinical Cure — baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days
The primary efficacy endpoint is percent of subjects with final clinical cure. Final clinical cure is defined as follows: * Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR, * Subject has initial clinical improvement (\> 50% re-epithelialization of index lesion by nominal Day 63) followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND, * Subject has no relapse of index lesion.
Countries
Panama