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

United States Army Medical Research and Development Command (USAMRDC)

Status and phase: Completed; Phase 2

Conditions: Cutaneous Leishmaniasis

Treatments: Device: ThermoMed; Drug: Sodium stibogluconate (Pentostam)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00884377

A-12364

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Department of Defense (DOD) Healthcare beneficiary
• Parasitologic diagnosis of cutaneous Leishmania infection

(Inclusion criteria for randomization includes that must be Leishmania major species)

• Willing to locate to WRAMC area during treatment and perform subsequent follow-up visits if needed

(If not active duty on orders, then the participant will bear the cost of food and lodging during the initial 10-day outpatient treatment period at Walter Reed Army Medical Center)

• Able to provide informed consent
• All participants (both male and female) must agree to take precautions not to become pregnant or father a child for at least 2 months after receiving sodium stibogluconate

Exclusion criteria

• Unable to provide informed consent

• Pregnancy (females of child bearing potential must have negative urine human chorionic gonadotropic hormone [HCG] within 48 hours of the start of infusion period)

• History of hypersensitivity to pentavalent antimonials

• Serious medical illness:

  1. QTc interval >/= 0.5 sec
  2. severe cardiac disease
  3. history of current pancreatitis
  4. liver failure or active hepatitis with transaminases >3X normal
  5. renal failure or creatinine >2.5
  6. thrombocytopenia (platelets <75,000)
  7. white blood cell count <2000
  8. hematocrit <25
  9. absence of palpable extremity pulses in the limb requiring treatment

• History of serious allergic reaction to local anesthetics

• Location of lesion not amenable to local therapy (such as close to eye, mucous membranes, face, cartilage)

• Presence of pacemaker and/or other implanted metallic devices

• Breast feeding

• Men unwilling to avoid fathering a child during and/or in the two months following receiving the treatment

• Women unwilling to avoid pregnancy for at least two months after receiving the treatment

• More than 20 lesions, or multiple lesions which in the opinion of the investigator would not be well treated with heat therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Sodium stibogluconate intravenous

Active Comparator group

Description:

20 mg/kg/day Sodium stibogluconate intravenous

Treatment:

Drug: Sodium stibogluconate (Pentostam)

ThermoMed device

Experimental group

Description:

ThermoMed device, single heat treatment at 50 degrees Celsius

Treatment:

Device: ThermoMed