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Double-blind, Randomized, Pharmacokinetics, Safety, and Efficacy Trial of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream for the Treatment of Cutaneous Leishmaniasis in Panama
The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in subjects with cutaneous leishmaniasis (CL).
Details
| Lead sponsor | U.S. Army Medical Research and Development Command |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 30 |
| Start date | 2010-03 |
| Completion | 2011-07 |
Conditions
- Leishmaniasis, Cutaneous
Interventions
- WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream)
- Paromomycin Alone Cream (15% paromomycin topical cream)
Primary outcomes
- Number of Participants Who Obtained Final Clinical Cure of Index Lesion — 168 days
Number of participants who had initial clinical cure (100% re-epithelialization of index lesion by Day 63) OR initial clinical improvements (\> 50% re-epithelialization of index lesion followed by Day 63 by 100% re-epithelialization of the index lesion on or before Day 100), AND no relapse of index lesion.
Countries
Panama