Conditions: Cutaneous Leishmaniasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 56
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 20 mg/kg/day Sodium stibogluconate intravenous arm 2: ThermoMed device, single heat treatment at 50 degrees Celsius

Interventions: intervention 1: Sodium stibogluconate (Pentostam) intervention 2: ThermoMed
Intervention descriptions: intervention 1: intravenous 20 mg/kg/day for 10 days intervention 2: ThermoMed heat treatment device, one treatment

Protocol document: