At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Peru
U.S. Army Medical Research and Development Command·interventional·Posted Dec 15, 2009·Updated Jul 16, 2015
In Brief
A Phase 2 clinical trial evaluating WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) and Paromomycin Alone Cream (15% paromomycin topical cream) for Leishmaniasis, Cutaneous. Completed, enrolled 30 participants across 1 site.
Detailed Summary
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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeishmaniasis, Cutaneous
CountriesPeru
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2009
Enrollment StartJan 2010
Primary CompletionMar 2011
Study CompletionJul 2011
TodayJul 2026
First PostedDec 15, 2009
Enrollment StartJan 1, 2010
Primary CompletionMar 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.5 years ago
Interventions
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream)drug
topical application to CL lesions once daily for 20 days
Paromomycin Alone Cream (15% paromomycin topical cream)drug
topical application to CL lesions once daily for 20 days