NCT00884377

Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A total of 56 Department of Defense health care beneficiaries, 18 years of age or older and diagnosed with cutaneous leishmaniasis, were planned to be treated with either intravenous sodium stibogluconate (Pentostam-TM) or the ThermoMed-TM device of Thermosurgery Technologies, Inc. at the Walter Reed Army Medical Center. Pentostam is the standard of care for this disease, but the i.v. administration and the many known side effects prompt the search for an improved method of treating this disease, especially for milder cases. This study compares the safety and efficacy of these two treatment approached.

Conditions

• Cutaneous Leishmaniasis

Interventions

Type	Name	Description
DRUG	Sodium stibogluconate (Pentostam)	intravenous 20 mg/kg/day for 10 days
DEVICE	ThermoMed	ThermoMed heat treatment device, one treatment

Timeline

• Start date: 2004-02-01
• Primary completion: 2009-01-01
• Completion: 2009-03-01
• First posted: 2009-04-20
• Last updated: 2020-01-02
• Results posted: 2017-07-14

Locations

1 site across 1 country: United States