CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 399 enrolled
Drug / intervention
WR 279,396 +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.

Search/NCT01790659
NCT01790659Phase 3Completed
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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

U.S. Army Medical Research and Development Command·interventional·Posted Feb 13, 2013·Updated Feb 14, 2018

In Brief

A Phase 3 clinical trial evaluating WR 279,396 and Paromomycin for Cutaneous Leishmaniasis. Completed, enrolled 399 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCutaneous Leishmaniasis
CountriesPanama
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 13, 2013
Enrollment StartMay 1, 2013
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 13.4 years ago

Interventions

WR 279,396drug

WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%

Paromomycindrug

Paromomycin alone