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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
intravenous 20 mg/kg/day for 10 days
ThermoMed heat treatment device, one treatment
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure
Assess whether local heat therapy using the ThermoMed device was equivalent (clinical cure) in efficacy to 10 days of parenteral sodium stibogluconate. Clinical cure is defined as complete epithelialization of lesion. post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test.
Time frame: Assessment of cure is made at 2 months after treatment
Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure
Determine the equivalence of efficacy (clinical cure) of ThermoMed treatment vs sodium stibogluconate in clinical response of all skin lesions at 12 months. Clinical cure is defined as complete epithelialization of lesion. Post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test.
Time frame: 12 months
Number of Participants With Solicited Adverse Events
To compare the toxicity profiles of ThermoMed treatment versus parenteral sodium stibogluconate therapy thru specific solicited adverse events
Time frame: Days 3, 7 and 10
Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments
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Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns.
Time frame: day 1 and day 10
Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments
Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns.
Time frame: day 1 and day 10
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
Evaluate the feasibility of using species-specific PCR as a rapid diagnostic assay for L. major infection. The comparator modalities were: histopathology (identification of amastigotes); speciation determined through culture and isoenzyme analysis; and genus and species-specific PCR. Species PCR testing was performed at baseline to allow for the identification of L. major as each subject's infecting parasite. If an L. major infection could not be confirmed in a subject's lesion(s), then that subject could not be treated under this protocol.
Time frame: at baseline before treatment