At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 92 enrolled
Drug / intervention
WR 279,396 +1 moredrug
Likely dose
WR 279,396 0.0005 mLfrom 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.
Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: a Phase 2 Study in the Old World
U.S. Army Medical Research and Development Command·interventional·Posted Jun 24, 2008·Updated May 30, 2017
In Brief
A Phase 2 clinical trial evaluating WR 279,396 and Placebo for Cutaneous Leishmaniasis. Completed, enrolled 92 participants across 2 sites in 2 countries.
Detailed Summary
This study is to determine the effectiveness and safety of WR 279,396, a topical cream for the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo control under double-blind conditions in a local population group in Tunisia where leishmaniasis is endemic.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCutaneous Leishmaniasis
CountriesFrance, Tunisia
CollaboratorsWalter Reed Army Institute of Research (WRAIR)
Timeline
Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2003
Primary CompletionNov 2004
Study CompletionNov 2005
First PostedJun 2008
TodayJul 2026
First PostedJun 24, 2008
Enrollment StartMar 1, 2003
Primary CompletionNov 1, 2004
Study CompletionNov 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.0 years ago
Interventions
WR 279,396drug
A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion
Placebodrug
Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion