At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 56 enrolled
Drug / intervention
Sodium stibogluconate (Pentostam) +1 moredrug
Likely dose
Sodium stibogluconate (Pentostam) 20 mg/kgfrom 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.
A Phase I/II Randomized Comparison of Localized Heat Therapy Versus Sodium Stibogluconate (Pentostam) for the Treatment of Old World Cutaneous Leishmaniasis (HSRRB Log No. A-12364)
U.S. Army Medical Research and Development Command·interventional·Posted Apr 20, 2009·Updated Jan 2, 2020
In Brief
A Phase 2 clinical trial evaluating Sodium stibogluconate (Pentostam) and ThermoMed for Cutaneous Leishmaniasis. Completed, enrolled 56 participants across 1 site.
Detailed Summary
This study serves to compare the effectiveness of treating cutaneous leishmaniasis with either intravenous sodium stibogluconate or direct heat therapy using the ThermoMed-TM device.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCutaneous Leishmaniasis
CountriesUnited States
CollaboratorsWalter Reed Army Medical Center
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2004
Primary CompletionJan 2009
Study CompletionMar 2009
First PostedApr 2009
TodayJul 2026
First PostedApr 20, 2009
Enrollment StartFeb 1, 2004
Primary CompletionJan 1, 2009
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 17.2 years ago
Interventions
Sodium stibogluconate (Pentostam)drug
intravenous 20 mg/kg/day for 10 days
ThermoMeddevice
ThermoMed heat treatment device, one treatment