Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis

Universidad Peruana Cayetano Heredia

Overview

Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable. Thermotherapy is a clinically validated first line alternative for the treatment of Cutaneous Leishmaniasis in South America. However, current heat-delivery modalities are either too costly or lack governmental approval required to be made widely available to endemic areas. The investigators have adapted a reliable, safe, and low-cost heat pack for Cutaneous Leishmaniasis that the investigators have named the HECT-CL device. In this pilot study the investigators will enroll 25 patients who have either failed or are not candidates for pentivalent antimonies. The hypothesis states that the HECT-CL device demonstrates efficacy non-statistically inferior to estimates for current South American Pentavalent Antimonial cure rates (76%) while demonstrating basic safety and tolerability.

Study Type

EXPANDED_ACCESS

Conditions

Cutaneous Leishmaniasis

Interventions

Heat pack conduction-heat therapyDEVICE

Hand warmer heat pack with reliable (and monitored) temperature (50-52 degrees Celsius) will be applied to lesion borders for 3 minutes (fractionated to 90 second intervals or less) every day, for 7 consecutive days.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * with CL diagnosed by skin smear (WHO method), biopsy, culture, PCR * aged 8-80 years old * with no more than 3 lesions * ulcerative and non-ulcerative ulcers less than 4 cm diameter. * allergy, prohibitive side effects to standard chemotherapy, or other contraindication to antimonial treatment (e.g. cardiac arrhythmia) * capable of signing an informed consent or having capable guardians (in the case of minors). * Children ≥ 8 years of age must give written or verbal informed assent along with written consent of their guardians. Exclusion Criteria: * lesions less than 2cm from the nose, mouth, ears, or eyes. * clinically diagnosed with mucosal involvement. * evidence of lymph node involvement on exam. * unable or unwilling to commit to the treatment and follow-up plan. * prior CL treatment within last 1 month. * pregnant or lactating * uncontrolled severe systemic illness or immunocompromised state.

Central Contacts

Alejandro Llanos-Cuentas, MD, PhD

CONTACT

51-1-482-7739 elmer.llanos@upch.pe

Data from ClinicalTrials.gov

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